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Category: Inflammatory Bowel Disease

Weekly Top News – IBD – July 6, 2020

July 6, 2020

Remsima SC (infliximab biosimilar SC) / Celltrion
Celltrion Healthcare Receives Positive CHMP Opinion for an Additional Five Indications for Remsima SC Including for Use in Inflammatory Bowel Disease and Ankylosing Spondylitis (Businesswire) – Jun 28, 2020 – “Celltrion Healthcare today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended expanding the existing marketing authorisation for the subcutaneous (SC) formulation of Remsima (CT-P13) in an additional five indications: for the treatment of patients with ankylosing spondylitis, Crohn’s disease, ulcerative colitis, psoriatic arthritis and psoriasis….’Remsima SC could offer patients an alternative administration method that provides adequate exposure during maintenance treatment with infliximab and takes significantly less time than the current intravenous formulation, thereby reducing the time patients need to be in medical settings with infusion administrations,’ said Professor Walter Reinisch….Celltrion has completed its application process for patent protection for the Remsima SC formulation and dosage, until 2037 and 2038 respectively in approximately 100 countries throughout the US, Europe and Asia.”

 

MORF-057 / Morphic Therap
Morphic Therapeutic Presents Positive Preclinical Data Supporting Development of MORF-057 in Inflammatory Bowel Disease at Digestive Disease Week 2020 (GlobeNewswire) – Jun 29, 2020 – “The data presented at DDW demonstrate that MORF-057 successfully targets the integrin α4β7 with high potency and selectivity. These studies recapitulate results from previous in vitro and in vivo models of increasing complexity and bolster the emerging profile of MORF-057 by demonstrating saturation of α4β7 in non-human primate receptor occupancy studies…IND filing on track for mid-year and phase 1 clinical trial expected third-quarter 2020…”

 

spesolimab (BI 655130) / Boehringer Ingelheim
BI 655130 Long-term Treatment in Patients With moderate-to Severe Ulcerative Colitis (clinicaltrials.gov) – Jul 1, 2020 – P2; N=79; Recruiting; Sponsor: Boehringer Ingelheim; N=535 –> 79

 

EUPHORIA: Enhancing Ultrasound & Photoacoustic for Recognition of Intestinal Abnormalities (clinicaltrials.gov) – Jul 2, 2020 – P; N=504; Not yet recruiting; Sponsor: iThera Medical GmbH

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Weekly Top News – IBD – June 29, 2020

June 29, 2020

BMS-986165 / BMS
BMS-986165: Data from P2 trial (NCT03934216) for moderate-to-severe ulcerative colitis in 2021 (Bristol-Myers Squibb) – Jun 27, 2020 – Investor Series Immunology and Cardiovascular: Data from P2 trial (NCT03599622) for moderate-to-severe Crohn’s disease in 2022 or later

 

 

Remsima SC (infliximab biosimilar SC) / Celltrion
Celltrion Healthcare Receives Positive CHMP Opinion for an Additional Five Indications for Remsima SC Including for Use in Inflammatory Bowel Disease and Ankylosing Spondylitis (Businesswire) – Jun 28, 2020 – “Celltrion Healthcare today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended expanding the existing marketing authorisation for the subcutaneous (SC) formulation of Remsima® (CT-P13) in an additional five indications: for the treatment of patients with ankylosing spondylitis, Crohn’s disease, ulcerative colitis, psoriatic arthritis and psoriasis….Celltrion has completed its application process for patent protection for the Remsima® SC formulation and dosage, until 2037 and 2038 respectively in approximately 100 countries throughout the US, Europe and Asia.”

 

Remicade (infliximab) / Mitsubishi Tanabe, J&J
Diversigen, Inc. and Alimentiv Inc. Announce Collaboration Agreement for Ulcerative Colitis Research Study (GlobeNewswire) – Jun 25, 2020 – “Diversigen, Inc….today announced they have signed a collaboration agreement for a research study on patients with Acute Severe Ulcerative Colitis (ASUC)….The study, titled: ‘Pharmacokinetics of Infliximab and Tumor Necrosis Factor Concentrations in Serum, Stool, and Colonic Mucosa in Acute Severe Ulcerative Colitis (PROTOS Study),’ is designed to provide new insights into the molecular determinants of response to infliximab (IFX) in patients with ASUC….The results will be jointly owned by Diversigen and Alimentiv, and the data will be co-published upon completion of the study.”

 

Entyvio (vedolizumab) / Takeda
BRIEF—FDA nod of for Takeda’s US Entyvio facility (The Pharma Letter) – Jun 24, 2020 – “…Takeda Pharmaceutical says the US Food and Drug Administration has approved the company’s submission for its biologics manufacturing facility located in Brooklyn Park, Minnesota for the production of Entyvio (vedolizumab) drug substance. The facility also has capabilities beyond production of Entyvio drug substance to support the study and development of future biologic products.”

 

Zeposia (ozanimod) / BMS
Open-Label Extension of RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis (clinicaltrials.gov) – Jun 23, 2020 – P3; N=869; Active, not recruiting; Sponsor: Celgene; Recruiting –> Active, not recruiting

Read More …

Weekly Top News – IBD – June 22, 2020

June 22, 2020

etrasimod (APD334) / Arena
Etrasimod: Data from P2b CULTIVATE trial (NCT04173273) for Crohn’s disease in mid-2021 (Arena) – Jun 18, 2020 – Corporate Presentation: Data from P3 trial for Crohn’s disease in H2 2022

 

etrasimod (APD334) / Arena
Etrasimod: NDA submission for ulcerative colitis in mid-2022 (Arena) – Jun 18, 2020 – Corporate Presentation

 

Stelara (ustekinumab) / J&J
Final NICE green light for Janssen’s Stelara in UC (PharmaTimes) – Jun 17, 2020 – “The National Institute for Health and Care Excellence (NICE) has now issued a final green light for NHS use of Janssen’s Stelara (ustekinumab) to treat ulcerative colitis. The decision permits NHS doctors to prescribe the drug to treat moderately to severely active ulcerative colitis (UC) in adults when conventional therapy or a biological agent cannot be tolerated, or the disease has responded inadequately or lost response to treatment, only if: a tumour necrosis factor (TNF)-alpha inhibitor has failed, cannot be tolerated, or is unsuitable….According to NICE, clinical trial evidence shows that Stelara is more effective than placebo for treating moderately to severely active ulcerative colitis….However, its endorsement is contingent upon Janssen providing Stelara at the same price or lower than that agreed…”

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy (clinicaltrials.gov) – Jun 17, 2020 – P2/3; N=720; Recruiting; Sponsor: AbbVie; N=1536 –> 720; Trial primary completion date: Sep 2020 –> Mar 2022

 

Xeljanz (tofacitinib) / Pfizer, Marche Polytechnic University
ANMAT approved the use of a medicine to treat ulcerative colitis [Google translation] (El Litoral) – Jun 17, 2020 – “The National Administration of Medicines, Foods and Medical Technology (ANMAT) approved in Argentina the use of an oral medication for the treatment of moderate to severe ulcerative colitis in adults. Approval was obtained from the results of three phase III clinical trials that integrate a global clinical development program called OCTAVE and that included more than 1,700 patients. This is a new indication for a medicine containing tofacitinib for the treatment of ulcerative colitis…”

 

Zeposia (ozanimod) / BMS
Safety and Efficacy Trial of RPC1063 for Moderate to Severe Ulcerative Colitis (clinicaltrials.gov) – Jun 16, 2020 – P3; N=1012; Active, not recruiting; Sponsor: Celgene; Recruiting –> Active, not recruiting; Trial completion date: Mar 2021 –> Jun 2020; Trial primary completion date: Jun 2020 –> Mar 2020

 

To Evaluate the Efficacy and Safety of FE 999315 in Japanese Subjects With Mild to Moderate Active Ulcerative Colitis (clinicaltrials.gov) – Jun 17, 2020 – P3; N=274; Completed; Sponsor: Ferring Pharmaceuticals; Active, not recruiting –> Completed

 

ALPN-101 / AbbVie
Alpine Immune Sciences and AbbVie announce option and license agreement for the development and commercialization of ALPN-101 (Businesswire) – Jun 18, 2020 – “Alpine Immune Sciences…and AbbVie…announced an exclusive worldwide option and license agreement for ALPN-101, a first-in-class dual CD28/ICOS costimulation antagonist….Under the terms of the agreement, Alpine will receive an upfront payment of $60 million, and will also be eligible to receive up to an aggregate of $805 million for exercise of the option and success-based development, regulatory and commercial milestones. In addition, Alpine is eligible to receive tiered royalties on net sales of ALPN-101. In exchange, AbbVie will receive an option to an exclusive license for ALPN-101. During the option period, Alpine will conduct a phase 2 study in systemic lupus erythematosus.”

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Weekly Top News – IBD – June 15, 2020

June 15, 2020

Alofisel (darvadstrocel) / Takeda
ADMIRE-CD-II: Study to Assess Efficacy and Safety of Cx601, Adult Allogeneic Expanded Adipose-derived Stem Cells (eASC) for the Treatment of Complex Perianal Fistula(s) in Participants With Crohn’s Disease (CD) (clinicaltrials.gov) – Jun 9, 2020 – P3; N=554; Recruiting; Sponsor: Tigenix S.A.U.; Active, not recruiting –> Recruiting

 

Xeljanz (tofacitinib) / Pfizer, Marche Polytechnic University
TOFAST: Tofacitinib in Adult Patients With Moderate to Severe Ulcerative Colitis (clinicaltrials.gov) – Jun 9, 2020 – P; N=280; Not yet recruiting; Sponsor: Pfizer

 

Humira (adalimumab) / Eisai, AbbVie
AbbVie dodges antitrust challenge to Its Humira ‘patent thicket’ (Bloomberg Law) – Jun 8, 2020 – “AbbVie Inc., Amgen Inc., a Samsung subsidiary, and Novartis unit Sandoz Inc. don’t have to face antitrust claims over patent infringement settlements that delayed generic competition for the blockbuster arthritis drug Humira, a Chicago federal judge ruled Monday….Dismissing the case, Shah noted that patent applications are normally covered by the Noerr-Pennington doctrine, which shields companies from antitrust liability for petitioning the government.”

 

CERC-002 / Kyowa Hakko Kirin, Sanofi, Cerecor
Cerecor Inc. announces proposed public offering of common stock (GlobeNewswire) – Jun 8, 2020 – “Cerecor Inc….announced today that it intends to offer for sale shares of its common stock in an underwritten public offering….Cerecor intends to use the net proceeds of the offering for general corporate purposes and working capital, primarily to support the ongoing clinical development of key assets within its pipeline and for general and administrative expenses.”

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Weekly Top News – IBD – June 8, 2020

June 8, 2020

etrasimod (APD334) / Arena
Etrasimod: Completion of enrollment of P3 ELEVATE UC 52 trial (NCT03945188) for ulcerative colitis in H2 2020 (Arena) – Jun 4, 2020 – Corporate Presentation: Data from P3 ELEVATE UC 12 trial (NCT03996369) for ulcerative colitis in H2 2021 

 

etrolizumab (RG7413) / Roche
A Study Comparing the Efficacy and Safety of Etrolizumab With Adalimumab and Placebo in Participants With Moderate to Severe Ulcerative Colitis (UC) in Participants Naive to Tumor Necrosis Factor (TNF) Inhibitors (Study #2) (clinicaltrials.gov) – Jun 4, 2020 – P3; N=358; Completed; Sponsor: Hoffmann-La Roche; Active, not recruiting –> Completed

 

Zeposia (ozanimod) / BMS
Bristol Myers Squibb announces positive topline results from pivotal phase 3 True North trial evaluating Zeposia (ozanimod) in patients with moderate to severe ulcerative colitis (Businesswire) – Jun 2, 2020 – P3, N=1,012; True North (NCT02435992); Sponsor: Celgene; “Bristol Myers Squibb (NYSE:BMY) today announced results from True North, a pivotal Phase 3 trial evaluating oral Zeposia (ozanimod)…for adult patients with moderate to severe ulcerative colitis. True North met both primary endpoints, demonstrating highly statistically significant (p-value < 0.0001) results for induction of clinical remission at Week 10 and in maintenance at Week 52….The company will complete a full evaluation of the True North data and work with investigators to present detailed results at a future medical meeting, as well as discuss these results with health authorities.”

 

Stelara (ustekinumab) / J&J
UK Health Agency recommends Stelara for moderately to severely active ulcerative colitis (IBD News Today) – Jun 1, 2020 – “The U.K. National Institute for Health and Care Excellence (NICE) has recommended the use of Stelara (ustekinumab) to treat patients with moderately to severely active ulcerative colitis specifically in adults when conventional and biological therapies are ineffective or not tolerated. Stelara’s developer, Janssen, anticipates that this recommendation may allow the treatment to be publicly available in England and Wales before the end of 2020.”

 

Zeposia (ozanimod) / BMS
TOUCHSTONE: Efficacy and Safety Study of RPC1063 in Ulcerative Colitis (clinicaltrials.gov) – Jun 2, 2020 – P2; N=196; Completed; Sponsor: Celgene; Active, not recruiting –> Completed

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Weekly Top News – IBD – June 1, 2020

June 1, 2020

ontamalimab (SHP647) / Takeda
European Commission releases Takeda from commitment to divest Shire’s pipeline compound SHP647 (Businesswire) – May 28, 2020 – Takeda will discontinue the current SHP647 clinical trial program, and it will be providing all eligible trial participants with the opportunity to have continued access to SHP647 in a post-trial access (‘PTA’) study. In addition, subject to obtaining trial participant consents and the satisfaction of regulatory and ethical considerations, Takeda will make SHP647 clinical trial data and biosamples available to the scientific community through the Crohn’s & Colitis Foundation….Takeda will no longer develop the SHP647 compound in any inflammatory bowel disease indication, including Ulcerative Colitis or Crohn’s Disease.”

 

etrasimod (APD334) / Arena
Arena completes full enrollment of etrasimod phase 2 ADVISE trial for atopic dermatitis, provides program updates (Arena Press Release) – May 26, 2020 – “Etrasimod ELEVATE UC 52 Phase 3 trial in ulcerative colitis (UC) ongoing and on track; ELEVATE UC 12 Phase 3 trial expected to initiate in H2 2020; topline data for both trials expected by year end 2021…Etrasimod CULTIVATE Phase 2b dose-ranging trial in Crohn’s disease (CD) initiated and ongoing; considering options to help facilitate availability of topline data in 2021; withdrawing previously announced overall program guidance based on expected COVID-19 impact on trial execution including site activation and enrollment…Olorinab CAPTIVATE Phase 2b trial in abdominal pain associated with irritable bowel syndrome (IBS-C, IBS-D) ongoing; experiencing some COVID-19 related impact on trial enrollment; topline data expected between Q4 2020 and Q1 2021…”

 

ontamalimab (SHP647) / Takeda
EU regulators allow Takeda to buy Shire without selling asset (Reuters) – May 28, 2020 – “Japan’s Takeda Pharmaceutical Co Ltd (4502.T) will not be required to sell a biologic drug, a concession made to address EU antitrust concerns over its 2018 bid to buy Shire, because market condition have changed, EU regulators said on Thursday….’On this basis, the Commission concluded that the combination of the above developments amounted to exceptional circumstances so that the divestment of SHP 647 was no longer necessary to render Takeda’s acquisition of Shire compatible with the internal market,’ the EU competition enforcer said.”

 

Rinvoq (upadacitinib) / AbbVie
U-ACHIEVE: A Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis (UC) (clinicaltrials.gov) – May 27, 2020 – P3; N=844; Recruiting; Sponsor: AbbVie; Trial primary completion date: Apr 2021 –> Oct 2021

 

Entyvio (vedolizumab) / Takeda
Vedolizumab IV in Pediatric Participants With Ulcerative Colitis (UC) or Crohn’s Disease (CD) (clinicaltrials.gov) – May 29, 2020 – P2; N=90; Completed; Sponsor: Takeda; Active, not recruiting –> Completed

 

ravagalimab (ABBV-323) / AbbVie
A Study to Investigate How Well Ravagalimab (ABBV-323) Works and How Safe it is in Participants With Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy (clinicaltrials.gov) – May 29, 2020 – P2; N=40; Recruiting; Sponsor: AbbVie; N=30 –> 40; Trial completion date: Nov 2021 –> Aug 2022

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Weekly Top News – IBD – May 25, 2020

May 25, 2020

spesolimab (BI 655130) / Boehringer Ingelheim
BI655130 (SPESOLIMAB) Induction Treatment in Patients With Moderate-to-severe Ulcerative Colitis (clinicaltrials.gov) – May 22, 2020 – P2/3; N=98; Completed; Sponsor: Boehringer Ingelheim; Active, not recruiting –> Completed

 

synthetic biotic therapeutic / Synlogic
Synlogic announces termination of AbbVie collaboration agreement (PRNewswire) – May 21, 2020 – “Synlogic, Inc….today announced the termination of its collaboration with AbbVie…for the development of Synthetic Biotic medicines for the potential treatment of inflammatory bowel disease (IBD)….Upon termination, Synlogic regains all rights to develop these and new IBD Synthetic Biotic medicines for all effectors targeting IBD. This allows Synlogic to fully leverage its expertise in strain engineering, quantitative biology, regulatory, and manufacturing of living medicines to expand its wholly owned GI-based program portfolio to include IBD. Synlogic further regains the rights to partner its IBD programs.”

 

filgotinib (GLPG0634) / Gilead
Gilead and Galapagos announce positive topline results of phase 2b/3 trial of filgotinib in moderately to severely active ulcerative colitis (GlobeNewswire) – May 20, 2020 – P2b/3, N=1,351; SELECTION1 (NCT02914522); Sponsor: Gilead Sciences; “Gilead Sciences…and Galapagos…today announced positive topline results from SELECTION…Phase 2b/3 trial evaluating the efficacy and safety of…filgotinib…adult patients with moderately to severely active ulcerative colitis (UC). Filgotinib 200 mg achieved all primary endpoints in the study, inducing clinical remission at Week 10 and maintaining clinical remission at Week 58 in a significantly higher proportion of patients compared with placebo. Filgotinib 100 mg did not achieve statistically significant clinical remission at Week 10.”

 

Tremfya (guselkumab) / J&J
A Study of Guselkumab in Participants With Moderately to Severely Active Crohn’s Disease (clinicaltrials.gov) – May 21, 2020 – P3; N=25; Not yet recruiting; Sponsor: Janssen Pharmaceutical K.K.

 

mirikizumab (LY3074828) / Eli Lilly
LUCENT 2: A Maintenance Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (clinicaltrials.gov) – May 19, 2020 – P3; N=1044; Recruiting; Sponsor: Eli Lilly and Company; Trial primary completion date: Jun 2021 –> Mar 2021

 

PF-06826647 / Pfizer
A Study To Evaluate The Safety And Efficacy Of PF-06826647 In Participants With Moderate To Severe Ulcerative Colitis (clinicaltrials.gov) – May 20, 2020 – P2b; N=202; Recruiting; Sponsor: Pfizer; Not yet recruiting –> Recruiting

 

AMT-101 / Applied Molecular Transport
Inflammatory disease biotech Applied Molecular Transport files for a $100 million IPO (Nasdaq) – May 18, 2020 – “Applied Molecular Transport’s pipeline contains lead candidate AMT-101…that has completed a Phase 1b trial for ulcerative colitis (UC). The company plans to initiate Phase 2 trials of AMT-101 in UC and related inflammatory indications between 2020 and 2021.”

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Weekly Top News – IBD – May 18, 2020

May 18, 2020

brazikumab (AMG 139) / AstraZeneca
AstraZeneca recovery of global rights to brazikumab (MEDI2070) from Allergan completed (AstraZeneca Press Release) – May 11, 2020 – “AstraZeneca has completed a previously communicated agreement to recover the global rights to brazikumab (formerly MEDI2070), a monoclonal antibody targeting IL23, from Allergan. AstraZeneca and Allergan have terminated their previous license agreement and all rights to brazikumab have therefore now returned to AstraZeneca….Under the termination agreement, Allergan will fund up to an agreed amount, estimated to be the total costs expected to be incurred by AstraZeneca until completion of the development of brazikumab for Crohn’s disease (CD) and ulcerative colitis (UC), including the development of a companion diagnostic.”

 

brazikumab (AMG 139) / AstraZeneca
Open-label Extension Study of Brazikumab in Crohn’s Disease (clinicaltrialsregister.eu) – May 12, 2020 – P3; N=1000; Sponsor: Allergan Limited

 

AK101 / Akesobio
Akeso gets approval for AK101 investigational New Drug Application in China (Reuters) – May 15, 2020 – “Announces approval for AK101 Investigational New Drug Application for ulcerative colitis in China”

 

PL8177 / Palatin Technologies
Palatin Technologies, Inc. reports third quarter fiscal year 2020 financial results and recent business highlights (PRNewswire) – May 12, 2020 – “A Phase 2 proof-of-concept clinical study with an oral formulation of PL8177 in ulcerative colitis patients is now targeted to start in the first half of calendar year 2021, with data readout in the first half of calendar year 2022.”

 

Stelara (ustekinumab) / J&J
SEAVUE: Safety and Efficacy of Adalimumab Versus Ustekinumab for One Year (clinicaltrials.gov) – May 14, 2020 – P3b; N=386; Active, not recruiting; Sponsor: Janssen Scientific Affairs, LLC; Trial primary completion date: Apr 2020 –> Dec 2020

 

LC51-0255 / LG Chem
LG Chem Life Sciences Innovation Center announces data from phase I study of its ulcerative colitis treatment LC51-0255 (Businesswire) – May 14, 2020 – “P1,N=110; NCT03174613; Sponsor: LG Chem; Positive topline results of oral LC51-0255 presented at virtual Digestive Disease Week (DDW) 2020 as ePoster…was well-tolerated in healthy subjects using once-daily oral administration for up to 21 days….We are delighted to be moving LC51-0255 into Phase II this year.”

 

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

 

KB295 / Kaleido
Kaleido Biosciences provides corporate update and reports first quarter 2020 financial results (GlobeNewswire, Kaleido Biosciences) – May 14, 2020 – “Initiating a clinical study later this year evaluating a new MMT candidate, KB295, in approximately 30 patients with mild-to-moderate ulcerative colitis (UC). Top-line results are expected in mid-2021.”

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Weekly Top News – IBD – May 11, 2020

May 11, 2020

filgotinib (GLPG0634) / Gilead
Filgotinib: Data from P2b/3 SELECTION1 trial (NCT02914522) for ulcerative colitis in Q2 2020 (Galapagos) – May 8, 2020 – Q1 2020 Results

 

brazikumab (AMG 139) / AbbVie
AbbVie and Allergan receive clearance from U.S. Federal Trade Commission for AbbVie’s acquisition of Allergan (AbbVie Press Release) – May 5, 2020 – “AbbVie…and Allergan…announced that the U.S. Federal Trade Commission (FTC) has accepted the proposed consent order in connection with AbbVie’s pending acquisition of Allergan. The acceptance by the FTC satisfies all required antitrust clearances needed to be obtained for the acquisition of Allergan by AbbVie. As part of the proposed consent, Allergan has agreed to divest brazikumab, an investigational IL-23 inhibitor in development for autoimmune diseases, to AstraZeneca and Zenpep, a treatment for exocrine pancreatic insufficiency due to cystic fibrosis and other conditions, to Nestle. Nestle also will be acquiring Viokace, another pancreatic enzyme preparation, as part of the same transaction.”

 

etrolizumab (RG7413) / Roche
LAUREL: A Study of the Efficacy and Safety of Etrolizumab Treatment in Maintenance of Disease Remission in Ulcerative Colitis (UC) Participants Who Are Naive to Tumor Necrosis Factor (TNF) Inhibitors (clinicaltrials.gov) – May 5, 2020 – P3; N=359; Completed; Sponsor: Hoffmann-La Roche; Active, not recruiting –> Completed; Trial completion date: Jul 2020 –> Apr 2020

 

TD-1473 / J&J
TD-1473: Data from P2 DIONE trial (NCT03635112) for Crohn’s disease in 2021 (Theravance) – May 7, 2020 – Q1 2020 Results: Data from P2b portion of P2b/3 RHEA trial (NCT03758443) for ulcerative colitis in 2021

 

etrolizumab (RG7413) / Roche
HICKORY: A Study of the Efficacy and Safety of Etrolizumab in Participants With Ulcerative Colitis Who Have Been Previously Exposed to Tumor Necrosis Factor (TNF) Inhibitors (clinicaltrials.gov) – May 8, 2020 – P3; N=609; Completed; Sponsor: Hoffmann-La Roche; Active, not recruiting –> Completed

 

Entyvio SC (vedolizumab SC) / Takeda
European Commission approves subcutaneous formulation of Entyvio (vedolizumab) for use as maintenance therapy in adults with moderately to severely active ulcerative colitis or Crohn’s disease (Takeda Press Release) – May 8, 2020 – “Takeda Pharmaceutical Company Limited…today announced that the European Commission has granted a Marketing Authorization for the subcutaneous (SC) formulation of Entyvio (vedolizumab), a gut-selective biologic for use as maintenance therapy in adults with moderately to severely active ulcerative colitis (UC) or Crohn’s disease (CD). Entyvio SC will be made available in both a pre-filled syringe and a pre-filled pen….This decision by the European Commission means that Entyvio SC is now approved for use in the 27 member states of the European Union, plus the United Kingdom, Norway, Liechtenstein and Iceland….In addition to having received approval from the European Commission, Entyvio SC has been submitted for regulatory review with other regulatory authorities worldwide.”

 

MORF-057 / Morphic Therapeutic
Morphic announces corporate highlights and first quarter 2020 financial results (GlobeNewswire, Morphic Therapeutic) – May 6, 2020 – “Data presented at ECCO Congress support MORF-057 in IBD; IND on track for mid-year. ‘At the ECCO meeting, we presented preclinical data that strongly support the development of our candidate MORF-057, an oral inhibitor of α4β7, which is on track to enter clinical studies for inflammatory bowel disease in the second half of this year. These data demonstrated high specificity for its intended biologic target and mechanistic equivalence to the approved intravenous therapeutic against α4β7, vedolizumab.'”

 

PN-10-943 / Protagonist Therapeutics
Protagonist Therapeutics reports first quarter financial results and provides corporate update (PRNewswire) – May 7, 2020 – “The results of the PTG-300 beta-thalassemia Phase 2 study will be presented at an upcoming medical conference in the second quarter of 2020….The Company is discontinuing clinical development for PTG-300 in beta-thalassemia and myelodysplastic syndromes….A Phase 2 study of PN-943 in approximately 150 patients with moderate-to-severe ulcerative colitis is currently planned.”

 

CERC-002 / Sanofi, Kyowa Hakko Kirin, Cerecor
Cerecor reports Q1 2020 results and update (GlobeNewswire, Cerecor Inc.) – May 7, 2020 – “CERC-002 (anti-LIGHT mAb) being developed for pediatric-onset Crohn’s disease expects initial data readout in Q1 2021 with the moratorium placed on endoscopy from the AGA”

 

filgotinib (GLPG0634) / Gilead
SELECTION1: Filgotinib in the Induction and Maintenance of Remission in Adults With Moderately to Severely Active Ulcerative Colitis (clinicaltrials.gov) – May 4, 2020 – P2b; N=1351; Completed; Sponsor: Gilead Sciences; Active, not recruiting –> Completed

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Weekly Top News – IBD – May 4, 2020

May 4, 2020

mirikizumab (LY3074828) / Eli Lilly
A Long-term Extension Study of Mirikizumab (LY3074828) in Participants With Crohn’s Disease (clinicaltrialsregister.eu) – Apr 28, 2020 – P3; N=778; Ongoing; Sponsor: Eli Lilly and Company

 

Stelara (ustekinumab) / J&J
NICE recommends Stelara (ustekinumab) for the treatment of moderately to severely active ulcerative colitis (PharmiWeb) – Apr 28, 2020 – “The Janssen Pharmaceutical Companies of Johnson & Johnson welcomes the National Institute for Health and Care Excellence (NICE) positive Final Appraisal Document (FAD) recommending Stelara (ustekinumab) as an option for treating moderately to severely active ulcerative colitis (UC) in adults when conventional therapy or a biological agent cannot be tolerated, or the disease has responded inadequately or lost response to treatment, only if: a tumour necrosis factor (TNF)-alpha inhibitor has failed (that is the disease has responded inadequately or has lost response to treatment) or a TNF-alpha inhibitor cannot be tolerated or is not suitable.”

 

Entyvio (vedolizumab) / Takeda
Efficacy of Vedolizumab in Crohn’s Disease Patients Naive to Biological Therapy (clinicaltrials.gov) – Apr 27, 2020 – P; N=100; Not yet recruiting; Sponsor: Pontifícia Universidade Católica do Paraná

 

ontamalimab (SHP647) / Takeda
Efficacy and Safety Study of SHP647 as Induction Therapy in Participants With Moderate to Severe Crohn’s Disease (CARMEN CD 305) (clinicaltrials.gov) – Apr 28, 2020 – P3; N=1032; Active, not recruiting; Sponsor: Shire; Recruiting –> Active, not recruiting

 

ontamalimab (SHP647) / Takeda
FIGARO UC 302: Efficacy and Safety Study of SHP647 as Induction Therapy in Participants With Moderate to Severe Ulcerative Colitis (clinicaltrials.gov) – Apr 28, 2020 – P3; N=740; Active, not recruiting; Sponsor: Shire; Recruiting –> Active, not recruiting

 

ontamalimab (SHP647) / Takeda
Efficacy and Safety Study of SHP647 as Induction Therapy in Participants With Moderate to Severe Crohn’s Disease (CARMEN CD 306) (clinicaltrials.gov) – Apr 28, 2020 – P3; N=1032; Active, not recruiting; Sponsor: Shire; Recruiting –> Active, not recruiting

 

ontamalimab (SHP647) / Takeda
FIGARO UC 301: Efficacy and Safety Study of SHP647 as Induction Therapy in Participants With Moderate to Severe Ulcerative Colitis (clinicaltrials.gov) – Apr 28, 2020 – P3; N=740; Active, not recruiting; Sponsor: Shire; Recruiting –> Active, not recruiting

 

A Study to Assess the Long-Term Safety of Ustekinumab Versus Other Biologics in Patients With Crohn’s Disease (clinicaltrials.gov) – May 1, 2020 – P; N=1056; Not yet recruiting; Sponsor: Janssen Scientific Affairs, LLC

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