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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