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Category: Psoriasis

Weekly Top News – Psoriasis – July 6, 2020

July 6, 2020

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
Study of Subcutaneous Risankizumab Injection to Assess Change in Palmoplantar Pustulosis Area and Severity Index [PPPASI] in Adult Japanese Participants With Palmoplantar Pustulosis (clinicaltrials.gov) – Jun 30, 2020 – P3; N=116; Not yet recruiting; Sponsor: AbbVie

 

Siliq (brodalumab) / Bausch Health, LEO Pharma, Kyowa Hakko Kirin
Efficacy and safety of brodalumab in adolescents from 12 to 17 years of age with moderate-to-severe plaque psoriasis (clinicaltrialsregister.eu) – Jun 30, 2020 – P3; N=120; Sponsor: LEO Pharma A/S

 

Ilumya (tildrakizumab-asmn) / Sun Pharma, Almirall
Sun Pharmaceutical Industries receives Japan MHLW approval for Ilumya (Business Standard) – Jun 29, 2020 – “Sun Pharmaceutical Industries announced that one of its wholly-owned subsidiaries has received approval from the Ministry of Health, Labour and Welfare (MHLW), Japan for Ilumya (tildrakizumab) for the treatment of plaque psoriasis in adult patients who have an inadequate response to conventional therapies.”

 

AVT02 (adalimumab biosimilar) / Cipla, Alvotech
Pharmacokinetic, Efficacy, Safety, and Immunogenicity of AVT02 With Moderate to Severe Chronic Plaque Psoriasis (clinicaltrials.gov) – Jul 1, 2020 – P3; N=448; Not yet recruiting; Sponsor: Alvotech Swiss AG

 

bimekizumab (UCB4940) / UCB; Humira (adalimumab) / Eisai, AbbVie
BE OPTIMAL: A Study to Test the Efficacy and Safety of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis (clinicaltrials.gov) – Jul 1, 2020 – P3; N=840; Recruiting; Sponsor: UCB Biopharma SRL; Suspended –> Recruiting

 

bimekizumab (UCB4940) / UCB
BE COMPLETE: A Study to Evaluate the Efficacy and Safety of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis (clinicaltrials.gov) – Jul 1, 2020 – P3; N=390; Recruiting; Sponsor: UCB Biopharma S.P.R.L.; Suspended –> Recruiting

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Weekly Top News – Psoriasis – June 29, 2020

June 29, 2020

bimekizumab (UCB4940) / UCB; Stelara (ustekinumab) / J&J
First Presentations of Bimekizumab Phase 3 Data Demonstrate Superior Skin Clearance Over Placebo and Stelara at Week 16 in Adults with Moderate-to-Severe Plaque Psoriasis (Canada Newswire) – Jun 22, 2020 – P3, N=435; BE READY (NCT03410992); P3, N=570; BE VIVID (NCT03370133); Sponsor: UCB Biopharma S.P.R.L.; “UCB Canada Inc., today shared the first presentations of data from the Phase 3 clinical development program of bimekizumab, its investigational IL-17A and IL-17F inhibitor, as part of a virtual session for the American Academy of Dermatology (AAD) 2020 Annual Meeting held on June 12, 2020. Patients treated with bimekizumab achieved superior skin clearance in both the BE VIVID and BE READY Phase 3 studies, compared to those who received placebo or Stelara (ustekinumab)….The two late-breaking presentations cited in this release are…Kim A. Papp, Andrew Blauvelt, Richard Langley…Kenneth Gordon…Mark Lebwohl.”

 

Skilarence (dimethyl fumarate) / Almirall; Fumaderm (dimethyl fumarate) / Biogen
To evaluate the long-term efficacy and tolerability of treatment with dimethyl fumarate in adults with chronic plaque psoriasis. Valutare l’efficacia e la tollerabilità a lungo termine del trattamento con dimetilfumarato in adulti affetti da psoriasi cronica a placche . (clinicaltrialsregister.eu) – Jun 25, 2020 – P3; N=300; Ongoing; Sponsor: ALMIRALL SPA

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
Israel approves new psoriasis treatment (The Jerusalem Post) – Jun 25, 2020 – “Skyrizi – A new treatment for psoriasis that has been recently approved is now being available to treat Israeli psoriasis patients and it has demonstrated therapeutic success, even in severe cases.”

 

BMS-986165 / BMS
BMS-986165: Data from P2 trial (NCT03881059) for psoriatic arthritis in H2 2020 (Bristol-Myers Squibb) – Jun 27, 2020 – Investor Series Immunology and Cardiovascular: Data from P2 trial (NCT03252587) for systemic lupus erythematosus in 2021

 

 

Novartis Cosentyx gains positive CHMP opinion for pediatric psoriasis, reinforcing established efficacy and safety profile (Novartis Press Release) – Jun 26, 2020 – “Novartis…today announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for Cosentyx® (secukinumab) for the treatment of moderate-to-severe plaque psoriasis in children and adolescents aged 6 to

 

bimekizumab (UCB4940) / UCB
A Study to Evaluate the Safe and Effective Use of the Prefilled Safety Syringe or the Auto-injector for the Subcutaneous Self-injection of Bimekizumab Solution by Subjects With Moderate to Severe Chronic Plaque Psoriasis (PSO) (clinicaltrials.gov) – Jun 23, 2020 – P3; N=38; Active, not recruiting; Sponsor: UCB Biopharma S.P.R.L.; N=255 –> 38

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Weekly Top News – Psoriasis – June 22, 2020

June 22, 2020

Stelara (ustekinumab) / J&J; Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
A Study of Subcutaneous Risankizumab Injection for Pediatric Participants With Moderate to Severe Plaque Psoriasis to Assess Change in Disease Symptoms (clinicaltrials.gov) – Jun 17, 2020 – P3; N=132; Not yet recruiting; Sponsor: AbbVie

 

Ilumya (tildrakizumab-asmn) / Sun Pharma, Almirall
AOTMiT: What will the Transparency Council do in July? [Google translation] (medexpress.pl) – Jun 17, 2020 – “AOTMiT published the Transparency Council’s work plan from July 1 to July 31….MEETING OF THE TRANSPARENCY COUNCIL NO. 28/2020 13 JULY 2020: Ilumetri (tildrakizumab) – CONDITIONAL Indication: as part of the drug program ‘Treatment of moderate to severe plaque psoriasis’; 30/2020 27 JULY 2020: Dupixent (dupilumabum) – CONDITIONAL Indication: as part of the drug program : ‘Treatment of severe form of atopic dermatitis (ICD-10 L20)’ Decision problem: preparation of a position on drug evaluation…”

 

Ilumya (tildrakizumab-asmn) / Sun Pharma, Almirall
Sun Pharma and Hikma enter into unique licensing settlement for Ilumya for Middle East & North Africa areas (Equitybulls) – Jun 15, 2020 – “Sun Pharmaceutical…announced that one of its wholly-owned subsidiaries and Hikma Pharmaceuticals PLC (Hikma) have entered into an exclusive licensing and distribution agreement for Ilumya…for the Middle East & North Africa (MENA) region….Hikma will be responsible for the registration and commercialization of the product in all MENA markets and Sun Pharma will be responsible for product supply…The term of this agreement is 15 years from first sale, with two years’ automatic renewal periods.”

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
Study to Assess the Safety and Change in Disease Symptoms of Risankizumab (Skyrizi Prefilled Syringe for Injection) in Adult Participants With Moderate to Severe Plaque Psoriasis (clinicaltrials.gov) – Jun 16, 2020 – P; N=3000; Not yet recruiting; Sponsor: AbbVie

 

Tremfya (guselkumab) / J&J
GULLIVER: A Study of Guselkumab in Naive or Bio-experienced Participants With Regional (Facial and Genital) Psoriasis (clinicaltrials.gov) – Jun 19, 2020 – P; N=400; Recruiting; Sponsor: Janssen-Cilag S.p.A.

 

Tremfya (guselkumab) / J&J
New phase 3 data for Tremfya (guselkumab), a first-in-class IL-23 p19 subunit iInhibitor, show consistent, high levels of skin clearance through four years in adult patients with moderate to severe plaque psoriasis (Businesswire) – Jun 15, 2020 – P3, N=992; VOYAGE 2 (NCT02207244); P3, N=837; VOYAGE 1 (NCT02207231); Sponsor: Janssen Research & Development, LLC; “The Janssen Pharmaceutical Companies of Johnson & Johnson today announced new long-term plaque psoriasis data for Tremfya® (guselkumab), a first-in-class treatment showing consistent, high levels of skin clearance at week 100 and week 204 (four years)…In the open-label extension of VOYAGE 2, at four years, 80 percent of patients who were treated with guselkumab 100 mg every 8 weeks (q8w), achieved at least 90 percent improvement in the Psoriasis Area and Severity Index (PASI 90) score….These data are being shared online as an accepted poster (P15300) by the American Academy of Dermatology….Separately, data…VOYAGE 1 trial…are also being shared online as a poster (P15287)…at week 48, approximately 42 percent of guselkumab-treated patients and 23 percent of adalimumab-treated patients were symptom-free.”

 

bimekizumab (UCB4940) / UCB
BE BRIGHT: A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis (clinicaltrials.gov) – Jun 19, 2020 – P3; N=1355; Active, not recruiting; Sponsor: UCB Biopharma S.P.R.L.; Recruiting –> Active, not recruiting

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Weekly Top News – Psoriasis – June 15, 2020

June 15, 2020

 Ilumya (tildrakizumab-asmn) / Sun Pharma, Almirall
Sun Pharma announces long-term insights into the clinical use of Ilumya (tildrakizumab-asmn) in a cross section of people living with moderate-to-severe plaque psoriasis (PRNewswire) – Jun 12, 2020 – “Sun Pharmaceutical Industries Ltd…announced that one of its wholly owned subsidiaries presented further evidence of the long-term use and cost-effectiveness of Ilumya (tildrakizumab-asmn) in moderate-to-severe plaque psoriasis at the American Academy of Dermatology (AAD) Virtual Meeting Experience 2020….Long-term analyses of the reSURFACE 1 and 2 extension studies found that Ilumya offers sustained and improved results in patients with moderate-to-severe plaque psoriasis….Another post-hoc analysis…saw continued improvement and sustained response rates when they maintained treatment for up to three years….A 10-year cost analysis study revealed that ILUMYA is among the most cost-effective first-line therapies….’Notably, 85 percent of the patients included in our analysis had never used a biologic before even though they have been living with psoriasis for over a decade,” said lead investigator Kim Papp, M.D., Ph.D….”

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim; Cosentyx (secukinumab) / Novartis
AbbVie presents new late-breaking data showing Skyrizi (risankizumab-rzaa) achieves superior rates of complete skin clearance versus Cosentyx (secukinumab) at 52 weeks (PRNewswire) – Jun 12, 2020 – P3, N=327; NCT03478787; Sponsor: AbbVie; “AbbVie…today announced new late-breaking phase 3b head-to-head data showing superior rates of skin clearance for Skyrizi (risankizumab-rzaa) to Cosentyx (secukinumab) at week 52…66 percent of psoriasis patients receiving Skyrizi achieved completely clear skin—100 percent clearance in the Psoriasis Area and Severity Index (PASI 100)—versus 40 percent of patients receiving Cosentyx at week 52 (p

 

Stelara (ustekinumab) / J&J; bimekizumab (UCB4940) / UCB
First presentations of bimekizumab phase 3 data demonstrate superior skin clearance over placebo and Stelara at week 16 in adults with moderate-to-severe plaque psoriasis (PRNewswire) – Jun 12, 2020 – P3, N=435; BE READY (NCT03410992); P3, N=570; BE VIVID (NCT03370133); Sponsor: UCB Biopharma S.P.R.L.; “UCB…announced the first presentations of data from the Phase 3 clinical development program of bimekizumab…as part of a virtual session for the American Academy of Dermatology (AAD) 2020 Annual Meeting….’Today’s results demonstrate that bimekizumab may offer rapid and consistent skin clearance results over the course of 12 months, which represents a profound and meaningful evolution for many people living with psoriasis,’ said Dr. Kenneth Gordon…Phase 2b data from the BE ABLE 2 psoriasis study will also be presented virtually for AAD 2020….The two late-breaking presentations cited in this release are…Kim A. Papp, Andrew Blauvelt, Richard Langley…Kenneth Gordon…Mark Lebwohl.”

 

Humira (adalimumab) / Eisai, AbbVie; Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim; Stelara (ustekinumab) / J&J
Abbvie’s psoriasis drug proves long-term treatment effect (Korea Biomedical Review) – Jun 10, 2020 – P=NA, N=NA; “Abbvie’s Skyrizi (ingredient: risankizumab) showed the best treatment efficacy and lasting effect on plaque psoriasis patients among existing biological products, Professor Youn Sang-woong of the Seoul National University Bundang Hospital said Wednesday….In a long-term study that compared Skyrizi and Stelara (ingredient: ustekinumab) and Humira (ingredient: adalimumab), researchers confirmed that the proportion of patients who achieved Psoriasis Area Severity Index (PASI) 90 at week 16 of treatment reached 75-90 percent.”

 

Ilumya (tildrakizumab-asmn) / Sun Pharma, Almirall
Sun Pharma plans to present clinical insights from 25 data abstracts across its dermatology portfolio at the 2020 AAD virtual meeting experience (PRNewswire) – Jun 11, 2020 – “Sun Pharmaceutical Industries Inc., USA (SPII) ‘Sun Pharma’ today announced 25 data abstracts from its dermatology portfolio will be presented at the American Academy of Dermatology (AAD) Virtual Meeting Experience 2020. The data presentations will highlight key clinical insights on Ilumya…The virtual meeting will take place from June 12 to June 14, 2020.”

 

Taltz (ixekizumab) / Eli Lilly, Second Xiangya Hospital of Central South University; Olumiant (baricitinib) / Incyte, Eli Lilly, University of Colorado; mirikizumab (LY3074828) / Eli Lilly
Lilly highlights the evolution of its dermatology portfolio at Annual American Academy of Dermatology Meeting (AAD) (PRNewswire) – Jun 12, 2020 – “Eli Lilly and Company…announced today that it will present new data from Taltz® (ixekizumab), Olumiant® (baricitinib), mirikizumab and lebrikizumab at the virtual American Academy of Dermatology (AAD) meeting. The data being highlighted at this year’s virtual conference include the latest therapeutic data available in dermatological conditions such as psoriasis and atopic dermatitis (AD). Lilly will present 24 e-Posters, including 14 for Taltz, five for baricitinib, three for mirikizumab and two for lebrikizumab…e-Posters…Presenting Authors: Mark Lebwohl, Andrew Blauvelt…Kim Papp…”

 

Enstilar (calcipotriene/betamethasone dipropionate) / LEO Pharma
LEO Pharma presents results from study of twice-weekly Enstilar (calcipotriene and betamethasone dipropionate) foam for topical use in long-term maintenance treatment of plaque psoriasis (Businesswire) – Jun 12, 2020 – P3, N=650; PSO-LONG (NCT02899962); Sponsor: LEO Pharma; “LEO Pharma…presented results from the Phase 3 PSO-LONG clinical trial. PSO-LONG compared the efficacy and safety of twice-weekly Enstilar; (calcipotriene and betamethasone dipropionate) Foam, versus foam vehicle for long-term (52-week) maintenance treatment for adult patients with plaque psoriasis.3,4 Results were presented as ePosters online at the American Academy of Dermatology (AAD) Virtual Meeting Experience (VMX) 2020….Enstilar (calcipotriene and betamethasone dipropionate) Foam met the primary endpoint in the PSO-LONG trial by prolonging time to first relapse versus foam vehicle (56 days vs. 30 days)…These results, as demonstrated by the primary endpoint, introduce new clinical data for the treatment of adult patients with plaque psoriasis,’ said Mark Lebwohl, M.D.”

 

AK111 / Akesobio
The first patient of Kangfang Biological (09926-HK) new drug AK111 was successfully enrolled [Google translation] (Finet Group) – Jun 7, 2020 – “Kangfang Bio-B (09926-HK) announced that…drug AK111…in the first phase 1b clinical trial in China, the first case of moderate to severe plaque psoriasis…patient has successfully completed enrollment and administration….AK111 has previously received IND approval for psoriasis in China…completed a phase I study on healthy subjects…safe and well tolerated at a single dose…currently conducting clinical studies of multiple dosing in patients with moderate to severe psoriasis in China.”

 

BMS-986165 / BMS
POETYK-PSO-2: An Investigational Study to Evaluate Experimental Medication BMS-986165 Compared to Placebo and a Currently Available Treatment in Participants With Moderate-to-Severe Plaque Psoriasis (clinicaltrials.gov) – Jun 9, 2020 – P3; N=1000; Active, not recruiting; Sponsor: Bristol-Myers Squibb; Trial completion date: Jul 2020 –> Dec 2020; Trial primary completion date: Jul 2020 –> Dec 2020

 

Enbrel (etanercept) / Pfizer, Amgen
Study To Evaluate The Impact Of Difficult To Treat Sites On Biological Response In Moderate-To-Severe Plaque Psoriasis(PsO). (clinicaltrials.gov) – Jun 11, 2020 – P; N=1; Not yet recruiting; Sponsor: Pfizer

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Weekly Top News – Psoriasis – June 8, 2020

June 8, 2020

Taltz (ixekizumab) / Eli Lilly, Second Xiangya Hospital of Central South University
EULAR 2020: Lilly’s Taltz (ixekizumab) continues to show robust and consistent efficacy in psoriatic arthritis (Eli Lilly Press Release) – Jun 3, 2020 – P3, N=363; SPIRIT-H2H (NCT02349295); P3, N=303; COAST-X (NCT02757352); Sponsor: Eli Lilly and Company; “Lilly also highlighted notable results from two additional studies. The SPIRIT-P2 study demonstrated sustained improvement in signs and symptoms of PsA…for up to three years in patients with prior inadequate response or intolerance to one or two tumor necrosis factor inhibitors (TNFi). In the Phase 3 COAST-X study…patients treated with Taltz saw improvement in fatigue, spinal pain and stiffness at Week 16.”

 

Tremfya (guselkumab) / J&J
New first-in-class phase 3 Tremfya (guselkumab) data demonstrate improvement in psoriatic arthritis joint and skin symptoms at week 52 (PharmiWeb) – Jun 3, 2020 – P3, N=383; DISCOVER-1 (NCT03162796); P3, N=741; DISCOVER-2 (NCT03158285); Sponsor: Janssen Research & Development, LLC; “The Janssen Pharmaceutical Companies of Johnson & Johnson today announced new data from two phase 3 clinical trials, DISCOVER-1 and DISCOVER-2, which showed that Tremfya (guselkumab) demonstrated improvements in multiple clinical outcomes including joint symptoms, skin symptoms, soft tissue inflammation, physical function and reduction in radiographic progression at week 52 in adult patients with active psoriatic arthritis (PsA)….In a separate study, data from DISCOVER-1 and DISCOVER-2 were analyzed as part of a network meta-analysis that compared the efficacy and safety of TREMFYA to other targeted biologic therapies for PsA. Twenty-six Phase 3 studies were included comparing the impact of 13 targeted therapies for PsA…The analysis is being shared as an abstract (Abstract AB0820) during the EULAR E-Congress18.”

 

Efleira (netakimab) / Biocad
Biocad presents results of clinical trial proving efficacy of netakimab at EULAR 2020 (Eurekalert) – Jun 5, 2020 – P3, N=194; PATERA (NCT03598751); Sponsor: Biocad; “Four abstracts present the results from an international randomized double-blind phase 3 clinical trial (PATERA) which demonstrate netakimab decreases disease activity and reduces skin manifestation of psoriatic arthritis through 24 weeks of therapy….The results of the clinical trials have shown that 80 patients (82%) in netakimab arm and 9 (9%) in the placebo arm achieved ACR20 at week 24….Netakimab was registered for treatment of ankylosing spondylitis and psoriatic arthritis in spring 2020 in Russia.”

 

bimekizumab (UCB4940) / UCB; Cimzia (certolizumab pegol) / Astellas, UCB, Eli Lilly
UCB shares breadth of innovative new data from rheumatology portfolio for EULAR 2020 E-Congress (PharmiWeb) – Jun 5, 2020 – “UCB…today announced significant new data on CIMZIA® (certolizumab pegol)…bimekizumab, that are being presented at the Annual European Congress of Rheumatology (EULAR) 2020. With a total of 14 accepted abstracts and five accepted as oral presentations across multiple rheumatology solutions, UCB’s research is set to take center stage at this year’s virtual congress.”

 

Taltz (ixekizumab) / Eli Lilly, Second Xiangya Hospital of Central South University
European advisory group backs new indications of five meds (SeekingAlpha) – May 31, 2020 – “The European Medicines Agency’s advisory group CHMP has adopted positive opinions backing labeling updates/new indications of the following drugs….Eli Lilly’s (NYSE:LLY) Taltz (ixekizumab): New indication for pediatric plaque psoriasis in children as young as six years old weighing at least 25 kg and adolescents who are candidates for systemic therapy.”

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
Abbvie to apply for pension psoriasis treatment ‘Skyrizi’ insurance today [Google translation] (Medifonews) – Jun 1, 2020 – “Abbvie Korea (CEO So-Young Kang) announced that health insurance benefits for the severe psoriasis treatment interleukin-23 (IL-23) inhibitor ‘Skyrizi (component name: Risankizumab)’ will be applied from June 1st….The insured drug price is KRW 2,49,580 when administered once for 3 months maintenance therapy (150 mg), in which 75 mg is injected twice, which is the same or similar to the existing interleukin inhibitors.”

 

Ilumya (tildrakizumab-asmn) / Sun Pharma, Almirall
Efficacy and Safety of Tildrakizumab in the Treatment of Scalp Psoriasi (clinicaltrials.gov) – Jun 5, 2020 – P3; N=214; Recruiting; Sponsor: Sun Pharma Global FZE; N=136 –> 214

 

IMU-935 / Immunic
IMU-935: “Pharmacokinetic results of single ascending dose cohorts 1-5 predictable dose-linear pharmacokinetics”; Psoriasis (Immunic Therapeutics, Jefferies Virtual Healthcare Conference 2020) – Jun 5, 2020 

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
Risankizumab Versus Secukinumab for Subjects With Moderate to Severe Plaque Psoriasis (clinicaltrials.gov) – Jun 4, 2020 – P3; N=327; Active, not recruiting; Sponsor: AbbVie; Trial completion date: Feb 2020 –> Jul 2020; Trial primary completion date: Feb 2020 –> Jul 2020

 

AK111 / Akesobio
The first patient of Kangfang Biological (09926-HK) new drug AK111 was successfully enrolled [Google translation] (Finet Group) – Jun 7, 2020 – “Kangfang Bio-B (09926-HK) announced that…drug AK111…in the first phase 1b clinical trial in China, the first case of moderate to severe plaque psoriasis…patient has successfully completed enrollment and administration….AK111 has previously received IND approval for psoriasis in China…completed a phase I study on healthy subjects…safe and well tolerated at a single dose…currently conducting clinical studies of multiple dosing in patients with moderate to severe psoriasis in China.”

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Weekly Top News – Psoriasis – June 1, 2020

June 1, 2020

IMU-935 / Immunic
IMU-935: Initiation of PART B of P1 trial in healthy volunteers in Q3 2020 (Immunic Therapeutics) – May 28, 2020 – R&D Day: Initiation of PART C of P1 trial for moderate-to-severe psoriasis in H2 2020 
[Screenshot]

 

llllllllll brepocitinib (PF-06700841) / Pfizer
A Study to Evaluate the Efficacy and Safety of PF-06700841 in Subjects With Active Psoriatic Arthritis (clinicaltrials.gov) – May 26, 2020 – P2b; N=218; Active, not recruiting; Sponsor: Pfizer; Recruiting –> Active, not recruiting

 

IMU-935 / Immunic
IMU-935: PK data from P1 trial for healthy volunteers in Q2 2020 (Immunic Therapeutics) – May 29, 2020 – Company Overview: Data from SAD and MAD parts of P1 trial for healthy volunteers later in 2020 
[Screenshot]

 

IMU-935 / Immunic
IMU-935: Data from PART C of P1 trial for psoriasis in 2021 (Immunic Therapeutics) – May 29, 2020 – R&D Day 
[Screenshot]

 

Siliq (brodalumab) / Bausch Health, LEO Pharma, Kyowa Hakko Kirin; Stelara (ustekinumab) / J&J
EMBRACE 1: Efficacy and Safety of Brodalumab in Adolescents From 12 to 17 Years of Age With Moderate-to-severe Plaque Psoriasis (clinicaltrials.gov) – May 28, 2020 – P3; N=120; Not yet recruiting; Sponsor: LEO Pharma; Trial completion date: Aug 2023 –> Nov 2023; Initiation date: Jun 2020 –> Sep 2020; Trial primary completion date: Oct 2022 –> Jan 2023

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Weekly Top News – Psoriasis – May 25, 2020

May 25, 2020

Enbrel (etanercept) / Pfizer, Amgen
Study to Evaluate the Efficacy of Enbrel as a Biological Treatment in Moderate to Severe Plaque Psoriasis Patients (clinicaltrials.gov) – May 21, 2020 – P; N=1; Not yet recruiting; Sponsor: Pfizer

 

Ilumya (tildrakizumab-asmn) / Sun Pharma, Almirall; Skilarence (dimethyl fumarate) / Almirall; Fumaderm (dimethyl fumarate) / Biogen
TRANSITION: Efficacy and Safety of Tildrakizumab in Participants With Moderate-to-Severe Chronic Plaque Psoriasis Who Are Non-Responders to Dimethyl Fumarate Therapy (clinicaltrials.gov) – May 20, 2020 – P4; N=250; Active, not recruiting; Sponsor: Almirall, S.A.; Recruiting –> Active, not recruiting

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Weekly Top News – Psoriasis – May 18, 2020

May 18, 2020

mirikizumab (LY3074828) / Eli Lilly
Mirikizumab: Data from P3 OASIS-1 trial (NCT03482011) for psoriasis in H2 2020 (Eli Lilly, Bank of America Merrill Lynch Global Healthcare Conference 2020) – May 15, 2020

 

ABY-035 / Affibody
Affibody and Inmagene announce strategic partnership to develop ABY-035 – a phase 2 drug candidate with best-in-class potential for auto-immune diseases (Cision) – May 16, 2020 – “Affibody AB (‘Affibody’) and Inmagene Biopharmaceuticals (‘Inmagene’) today announced a strategic partnership to develop and commercialize ABY-035, a bispecific molecule targeting Interleukin-17A (IL-17), for multiple auto-immune diseases. Inmagene will be responsible for commercialization in mainland China, Hong Kong, Taiwan, and Macau (Greater China), and South Korea, as well as development activities in the Asia Pacific region, excluding Japan. Affibody will retain global commercial rights outside of Greater China and South Korea. The partners will work together to enroll patients into global registrational trials to support Biologics License Applications (BLAs) in multiple indications worldwide.”

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
A Study Comparing Risankizumab to Placebo in Participants With Active Psoriatic Arthritis (PsA) Who Have a History of Inadequate Response to or Intolerance to at Least One Disease Modifying Anti-Rheumatic Drug (DMARD) Therapy (clinicaltrials.gov) – May 12, 2020 – P3; N=964; Active, not recruiting; Sponsor: AbbVie; Recruiting –> Active, not recruiting; Trial primary completion date: Jan 2021 –> Oct 2020

 

EDP1815 / Evelo Biosci
Evelo Biosciences reports first quarter financial results and business highlights (GlobeNewswire) – May 11, 2020 – “Selected enteric capsule formulation of EDP1815 for Phase 2 dose ranging trial in psoriasis; trial initiation now expected in 3Q 2020, with interim data in mid-2021….This study will evaluate three doses of the enteric capsule formulation of EDP1815 versus placebo in approximately 225 individuals with mild to moderate psoriasis. The primary endpoint will be mean reduction in PASI score at 16 weeks….Evelo also announced interim data from cohorts of individuals with either mild to moderate psoriasis…who were treated with the newer, alternate formulation of EDP1815 in the ongoing Phase 1b studies. Meaningful clinical responses were not observed in either cohort. Based on these data, Evelo is discontinuing development of the alternate formulation.”

 

GSK2831781 / GSK
GSK2831781: Proof-of-concept data from P1 trial (NCT03965533) for psoriasis in H2 2020 (Immutep) – May 14, 2020 – NWR Virtual Small Cap Health Conference

 

Stelara (ustekinumab) / J&J
PROUST: A Study to Characterize Profile of Participant With Psoriatic Arthritis Depending on Whether Their Disease is Managed by a Dermatologist or by a Rheumatologist, and Starting Ustekinumab (clinicaltrials.gov) – May 14, 2020 – P=N/A; N=221; Completed; Sponsor: Janssen Cilag S.A.S.; Active, not recruiting –> Completed

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Weekly Top News – Psoriasis – May 11, 2020

May 11, 2020

Otezla (apremilast) / Amgen
Amgen announces positive top-line results from Otezla (apremilast) phase 3 ADVANCE study in mild-to-moderate plaque psoriasis (BioSpace) – May 6, 2020 – P3, N=595; ADVANCE (NCT03721172); Sponsor: Amgen; “Amgen (NASDAQ:AMGN) today announced positive top-line results from the ADVANCE trial, a phase 3, multicenter, randomized, placebo-controlled, double-blind study to assess the efficacy of Otezla (apremilast) in adults with mild-to-moderate plaque psoriasis. The study showed that oral Otezla 30 mg twice daily achieved a statistically significant improvement, compared with placebo, in the primary endpoint of the static Physician’s Global Assessment (sPGA) response (defined as an sPGA score of clear (0) or almost clear (1) with at least a 2-point reduction from baseline) at week 16….Detailed results will be submitted for presentation at an upcoming medical meeting.”

 

BMS-986165 / BMS
Bristol-Myers Squibb Co (BMY) Q1 2020 earnings call transcript (The Motley Fool) – May 7, 2020 – “Phase III trials both 046, 047 completed enrollment. So at this time, we are looking at follow-up of these patients, collection of the data and screening activity, so that we can approach the database lock. There is no reason to believe that there will be any delays. We’re looking toward — at the end of the year for readout of the first study 046 and first quarter of next year for 047 for the psoriasis program.”

 

EDP1815 / Evelo Biosci
Evelo Biosciences reports first quarter financial results and business highlights (GlobeNewswire) – May 11, 2020 – “Selected enteric capsule formulation of EDP1815 for Phase 2 dose ranging trial in psoriasis; trial initiation now expected in 3Q 2020, with interim data in mid-2021….This study will evaluate three doses of the enteric capsule formulation of EDP1815 versus placebo in approximately 225 individuals with mild to moderate psoriasis. The primary endpoint will be mean reduction in PASI score at 16 weeks….Evelo also announced interim data from cohorts of individuals with either mild to moderate psoriasis…who were treated with the newer, alternate formulation of EDP1815 in the ongoing Phase 1b studies. Meaningful clinical responses were not observed in either cohort. Based on these data, Evelo is discontinuing development of the alternate formulation.”

 

IMU-935 / Immunic
Immunic, Inc. reports first quarter 2020 financial results and highlights recent activity (PRNewswire) – May 8, 2020 – “The current, single ascending dose part of the ongoing phase 1 trial of IMU-935, being conducted in Australia, is planned to be followed by a multiple ascending dose (MAD) portion in healthy volunteers and a safety evaluation in patients with mild-to-moderate psoriasis as a third part of this phase 1 trial. Based on the temporary pausing of trials in healthy volunteers imposed by Ethics Committees in Australia due to COVID-19, the MAD portion of the trial is expected to start in the second half of 2020.”

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Weekly Top News – Psoriasis – May 4, 2020

May 4, 2020

Siliq (brodalumab) / Bausch Health, Leo Pharma, Kyowa Hakko Kirin
Brodalumab: Regulatory decision in China for psoriasis in H2 2020 (Kyowa Hakko Kirin Pharma) – May 1, 2020 – Q1 2020 Results 

 

Cosentyx (secukinumab) / Novartis
pINPOINt: A Study of Secukinumab Treatment in Patients With Plaque Psoriasis and Coexisting Non-alcoholic Fatty Liver Disease (NAFLD) (clinicaltrials.gov) – Apr 28, 2020 – P3; N=90; Suspended; Sponsor: Novartis Pharmaceuticals; Not yet recruiting –> Suspended

 

Otezla (apremilast) / Amgen
Amgen Inc (AMGN) Q1 2020 earnings call transcript (Amgen Press Release) – Apr 30, 2020 – “Otezla was acquired on Nov. 21, 2019 and generated $479 million of sales in the first quarter of 2020….Data from the Phase 3 study in patients with mild-to-moderate psoriasis are expected in Q2 2020….Aimovig® (erenumab-aooe) sales increased 20% driven by 46% volume growth, offset partially by lower net selling price as we expanded patient access.”

 

GSK2831781 / GSK
GSK2831781: Expiry of patents related to composition-of-matter and methods of treatment in 2036 (Immutep) – Apr 30, 2020 – Investor Presentation


 

Stelara (ustekinumab) / J&J
Stelara: Patent expiry in US in 2023 (J&J) – Apr 26, 2020 – Annual Meeting of Shareholders

 

Stelara (ustekinumab) / J&J
Comparative Study to Evaluate the Pharmacokinetics of BAT2206 vs Stelara® in Healthy Subjects (clinicaltrials.gov) – May 1, 2020 – P1; N=270; Not yet recruiting; Sponsor: Bio-Thera Solutions

 

PF-06700841 / Pfizer
Dose Ranging Study To Assess Efficacy, Safety and Tolerability Of PF-06700841 Topical Cream In Psoriasis (clinicaltrials.gov) – Apr 28, 2020 – P2b; N=240; Recruiting; Sponsor: Pfizer; Trial completion date: May 2020 –> Apr 2021; Trial primary completion date: May 2020 –> Apr 2021

 

Otezla (apremilast) / Amgen
REWARD: A Study of Apremilast Use and Effectiveness in Patients With Psoriatic Arthritis in The Netherlands (clinicaltrials.gov) – Apr 29, 2020 – P=N/A; N=200; Recruiting; Sponsor: Amgen; Trial completion date: Mar 2020 –> Jun 2022; Trial primary completion date: Mar 2020 –> Jun 2022

 

Otezla (apremilast) / Amgen
REALIZE: A Study to Assess Benefits of Apremilast in Patients With Moderate to Severe Chronic Plaque Psoriasis Followed by Dermatologists Under Real Life Settings in France (clinicaltrials.gov) – Apr 28, 2020 – P=N/A; N=500; Recruiting; Sponsor: Amgen; Trial primary completion date: Mar 2020 –> Mar 2021

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