お知らせ • Jun 24
Agomab Therapeutics NV Announces Design Of NOV-ERA Phase 2b Study With Ontunisertib In Fibrostenosing Crohn’s Disease Agomab Therapeutics NV announced the design of its upcoming Phase 2b NOV-ERA study with ontunisertib, its investigational oral gastro-intestinal (GI)-restricted small molecule inhibitor of ALK5 (or TGF-ß RI) for the potential treatment of Fibrostenosing Crohn’s Disease (FSCD). Approximately 46% of Crohn’s disease patients have FSCD, or fibrotic strictures in the intestinal tract, which can cause obstructive symptoms leading to dietary change, malnutrition and surgery. Despite the large unmet medical need, there are no approved pharmacological therapies for FSCD. The Company has aligned with the FDA on the study design of NOV-ERA, including the study’s primary efficacy endpoint of endoscopic passability at Week 24 as assessed by the SES-CD narrowing score, as well as several secondary efficacy endpoints relevant to patients with FSCD. The protocol has been submitted to the FDA and has cleared central Institutional Review Board (IRB) approval in the U.S. In addition, the study has received approval by Health Canada. The Company has also submitted Clinical Trial Applications in multiple countries globally, including in the European Union and Asia Pacific territories. The Company expects to initiate the NOV-ERA study following receipt of applicable regulatory and ethics approvals and plans to dose the first participants in the second half of 2026. The planned NOV-ERA study is a randomized, double-blind, placebo-controlled, dose-ranging, multicenter Phase 2b trial to assess the efficacy and safety of ontunisertib in participants diagnosed with symptomatic FSCD. The trial is expected to enroll up to 320 adult patients globally. To be eligible for the trial, participants must have at least one naive or anastomotic endoscopically non-passable ileal stricture, confirmed by a centrally read Simple Endoscopic Score for Crohn’s Disease (SES-CD). Upon study initiation, participants will be randomized in a 1:1:1:1 ratio to receive either ontunisertib at one of three dose levels (400 mg, 200 mg, and 100 mg), or a matching placebo, administered twice daily. The trial will consist of a 6-week screening period, a 52-week treatment period, and a 2-week follow-up period. The primary endpoint is the proportion of patients achieving endoscopic passability of the ileal index stricture at Week 24. Key secondary efficacy endpoints include: Proportion of participants achieving endoscopic passability of the ileal index stricture at Week 52. Change from baseline in Magnetic Resonance Enterography (MRE) imaging features of the index stricture at Week 24 and Week 52. Change from baseline in total SES-CD at Week 24 and Week 52. Proportion of participants with an endoscopic response and remission at Week 24 and Week 52 compared to baseline. Change from baseline in Patient-Reported Outcome questionnaire for stricturing Crohn’s disease (S-PRO 2.0) severity score at Week 24 and Week 52. Time to an FSCD-related event (including surgery and endoscopic balloon dilation). The endpoints assessed in the NOV-ERA study are designed to inform the selection of potential registrational endpoints for ontunisertib in FSCD. Ontunisertib is an investigational drug and not approved by any regulatory authority. Its efficacy and safety have not been established. Ontunisertib (AGMB-129) is an oral small molecule GI-restricted inhibitor of ALK5 (or TGF-ß RI) currently in clinical development for the treatment of Fibrostenosing Crohn’s Disease (FSCD). TGF-ß is a major driver of fibrosis. Ontunisertib is specifically designed to inhibit ALK5/TGF-ß in the GI-tract. Rapid first-pass metabolism in the liver prevents clinically relevant systemic exposure, potentially delivering an improved safety profile over systemically available inhibitors in this class. Ontunisertib has received U.S. FDA Fast Track Designation. Crohn’s disease is a chronic progressive disease of the gastrointestinal tract. It is estimated that approximately 46% of patients with Crohn’s disease have fibrosis of the gastrointestinal tract, resulting in stricture formation and intestinal obstructions, most frequently in the terminal ileum. These strictures can cause obstructive symptoms leading to dietary change, malnutrition and surgery. Despite the large unmet medical need, there are no approved pharmacological therapies for FSCD. お知らせ • Apr 27
AgomAb Therapeutics NV, Annual General Meeting, May 26, 2026 AgomAb Therapeutics NV, Annual General Meeting, May 26, 2026, at 16:00 Romance Standard Time. Location: posthoflei 1 box 6, 2600, antwerp (berchem), Belgium Board Change • Feb 18
High number of new and inexperienced directors There are 8 new directors who have joined the board in the last 3 years. The company's board is composed of: 8 new directors. 2 experienced directors. No highly experienced directors. Non-Executive Independent Director Ohad Hammer is the most experienced director on the board, commencing their role in 2019. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors. お知らせ • Feb 06
AgomAb Therapeutics NV has completed an IPO in the amount of $200 million. AgomAb Therapeutics NV has completed an IPO in the amount of $200 million.
Security Name: American Depositary Shares
Security Type: Depositary Receipt (Common Stock)
Securities Offered: 12,500,000
Price\Range: $16
Discount Per Security: $1.12