ontunisertib (AGMB-129) / AgomAb Therapeutics - LARVOL DELTA

Human Mass Balance Study of [14C] Ontunisertib in Healthy Volunteers (clinicaltrials.gov) - P1 | N=8 | Recruiting | Sponsor: Agomab Spain S.L.U. | Not yet recruiting ➔ Recruiting | Trial completion date: Dec 2026 ➔ Sep 2026 | Trial primary completion date: Dec 2026 ➔ Sep 2026

Enrollment open • Trial completion date • Trial primary completion date • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease

STENOVA TRIAL UPDATE: OPEN-LABEL EXTENSION OF ONTUNISERTIB IN FIBROSTENOSING CROHN'S DISEASE WITH OBJECTIVE IMAGING EFFICACY ASSESSMENTS (UEGW 2026) - No abstract available

Clinical • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease

NOV-ERA - A Clinical Trial to Assess the Efficacy and Safety of Ontunisertib Compared to Placebo in Patients With Fibrostenosing Crohn's Disease (clinicaltrials.gov) - P2 | N=320 | Recruiting | Sponsor: Agomab Spain S.L.U. | Not yet recruiting ➔ Recruiting

Enrollment open • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease

First Half 2026 Program Highlights and Anticipated Milestones: Ontunisertib (AGMB-129) (GlobeNewswire) - "Regulatory alignment with U.S. Food and Drug Administration (FDA) on key elements of NOV-ERA Phase 2b study design with Ontunisertib in Fibrostenosing Crohn’s Disease (FSCD), including Novel Primary Endpoint of Endoscopic Passability; Topline Data from Open-Label Long-term Extension Study (OLE) Part of STENOVA Study with Ontunisertib in FSCD...On Track to Initiate NOV-ERA Phase 2b Study in FSCD with Ontunisertib."

FDA event • P2 data • Crohn's disease

STENOVA - A Study to Evaluate Safety, Tolerability, PK and PD of AGMB-129 in Patients With Fibrostenotic Crohn's Disease (clinicaltrials.gov) - P2 | N=103 | Completed | Sponsor: Agomab Spain S.L.U. | Active, not recruiting ➔ Completed

Trial completion • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease

Anti-fibrotic therapy in Crohn's disease: hype or reality-can intestinal fibrosis Be targeted effectively? (PubMed, Expert Rev Gastroenterol Hepatol) - "This special report summarizes emerging anti-fibrotic strategies in Crohn's disease, including clinical data for ontunisertib and preclinical evidence for anti-TL1A therapies and obefazimod. Early clinical and translational findings suggest that targeting fibrosis in Crohn's disease may be feasible. In the authors' view, the greater challenge lies in developing the tools and trial frameworks needed to demonstrate that therapies can alter the course of fibrostenotic disease."

Journal • Crohn's disease • Fibrosis • Gastroenterology • Hepatology • Immunology • Inflammation • Inflammatory Bowel Disease

NOV-ERA - A Clinical Trial to Assess the Efficacy and Safety of Ontunisertib Compared to Placebo in Patients With Fibrostenosing Crohn's Disease (clinicaltrials.gov) - P2 | N=320 | Not yet recruiting | Sponsor: Agomab Spain S.L.U.

New P2 trial • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease

Human Mass Balance Study of [14C] Ontunisertib in Healthy Volunteers (clinicaltrials.gov) - P1 | N=8 | Not yet recruiting | Sponsor: Agomab Spain S.L.U.

New P1 trial • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel 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-β RI) for the potential treatment of Fibrostenosing Crohn’s Disease (FSCD) (GlobeNewswire) - "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 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."

Clinical protocol • New P2b trial • Crohn's disease

Ontunisertib (AGMB-129), a gut-restricted small molecule inhibitor of ALK5 for the treatment of FSCD (GlobeNewswire) - "We continue to have positive interactions with the FDA to align on the study design of the Phase 2b study with ontunisertib in FSCD and are on track to initiate the study in the second half of 2026. We are progressing the OLE part of the STENOVA study (Part B) with ontunisertib in FSCD patients, with topline results expected in the second half of 2026....As of February 2026, the Data Safety and Monitoring Board has not raised any safety issue and has recommended for the OLE study to continue as per the protocol with 200mg BID ontunisertib for up to 60 weeks."

DSMB • FDA event • New P2b trial • P2a data • Crohn's disease

Results from the STENOVA trial: A Phase 2a, randomized, placebo-controlled, double-blind study to assess the safety, pharmacokinetics (PK), and pharmacodynamics of ontunisertib (AGMB-129) in patients with Fibrostenotic Crohn’s Disease (FSCD) (ECCO-IBD 2026) - "A trend of improvements in endoscopic and MRE outcomes was observed. The data suggest that ontunisertib has potential to be the first ALK5 inhibitor suitable for chronic dosing in humans and may provide a therapeutic option for FSCD patients."

Clinical • P2a data • PK/PD data • Crohn's disease • Immunology • Inflammatory Bowel Disease • TGFB1 • TGFBR1

Belgium biotech Agomab outlines up to $212M Nasdaq debut to fund immunology trials (FierceBiotech) - "Dubbed ontunisertib, the ALK5 inhibitor demonstrated its ability to target the correct part of the intestine in a phase 2 trial of fibrostenosing Crohn’s disease last year....Now, Agomab plans to use the IPO money to launch a global phase 2b study of the oral small molecule in fibrostenosing Crohn's disease....Some of the planned IPO proceeds will also go toward starting a midstage study of AGMB-447, another ALK5 inhibitor from Origo. Agomab is already running a phase 1 study of AGMB-447 in both healthy volunteers and patients with idiopathic pulmonary fibrosis, with a top-line readout expected later this year."

Financing • Crohn's disease • Idiopathic Pulmonary Fibrosis

A Multiple Ascending Dose Study With AGMB-129 in Healthy Participants (clinicaltrials.gov) - P1 | N=30 | Completed | Sponsor: Agomab Spain S.L.U. | Trial completion date: Dec 2025 ➔ Sep 2025 | Trial primary completion date: Dec 2025 ➔ Sep 2025 | Recruiting ➔ Completed

Trial completion • Trial completion date • Trial primary completion date • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease

Agomab Announces Positive Topline Phase 2a Data for Ontunisertib in Fibrostenosing Crohn’s Disease (The Manila Times) - "Part A of the STENOVA study achieved its primary endpoint, with the observed safety profile supporting further clinical development. The severity and incidence of adverse events were similar among treatment arms, including placebo. There were no signs of treatment related cardiac toxicity, no pro-inflammatory effects, and no signals in safety labs, vital signs, and physical exams....The company plans to discuss the STENOVA results with regulatory authorities and prepare for a Phase 2b study."

P2a data • Crohn's disease

A Multiple Ascending Dose Study With AGMB-129 in Healthy Participants (clinicaltrials.gov) - P1 | N=40 | Recruiting | Sponsor: Agomab Spain S.L. | Not yet recruiting ➔ Recruiting

Enrollment open • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease

A Multiple Ascending Dose Study With AGMB-129 in Healthy Participants (clinicaltrials.gov) - P1 | N=40 | Not yet recruiting | Sponsor: Agomab Spain S.L.

New P1 trial • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease

Agomab Completes $89 Million Series D Financing to Support Broad Fibrosis-Focused Pipeline [Google translation] (Sohu.com) - "Agomab Therapeutics NV...announced the completion of a USD 89 million (EUR 82.1 million) Series D financing round, with participation from new investors Sanofi and Invus, as well as existing investors....The proceeds from the Series D financing will be used to further advance the clinical development of Agomab's lead candidate, AGMB-129, a gut-restricted, oral, small molecule inhibitor of ALK5 (TGFβ1R) for patients with fibrotic Crohn's disease (FSCD). Interim data from the Phase 2a STENOVA trial are expected in the first quarter of 2025. In addition, the proceeds will be used to advance the clinical development of AGMB-447, a lung-restricted inhaled small molecule inhibitor of ALK5, which is currently in a Phase 1 clinical trial in healthy subjects and patients with idiopathic pulmonary fibrosis (IPF); and the initial clinical development of AGMB-101..."

Financing • P2a data • Crohn's disease • Idiopathic Pulmonary Fibrosis • Liver Cirrhosis

Late-Breaking Interim STENOVA Data Presented at Digestive Disease Week 2025 Demonstrate Potential of AGMB-129 in Fibrostenosing Crohn’s Disease (GlobeNewswire) - P2a | N=103 | STENOVA (NCT05843578) | Sponsor: Agomab Spain S.L. | "The interim analysis was conducted on the first 44 patients after 12 weeks of treatment and indicated that the primary endpoint of favorable safety and tolerability of AGMB-129 was met at both doses....The study also met its two predefined secondary endpoints of pharmacokinetics (PK) and target engagement in the first 44 patients. The PK data indicated very low systemic exposure to AGMB-129 and high exposure to its inactive main metabolite MET-158....The STENOVA study is fully recruited, and on track to report results on 103 patients in the fourth quarter of this year."

P2a data • Crohn's disease

A PHASE 2A, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND STUDY TO ASSESS THE SAFETY, PHARMACOKINETICS (PK) AND PHARMACODYNAMICS (PD) OF AGMB-129 IN PATIENTS WITH FIBROSTENOTIC CROHN'S DISEASE: INTERIM RESULTS FROM THE STENOVA TRIAL (DDW 2025) - No abstract available

Clinical • P2a data • PK/PD data • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease

AGMB-129-C102: STENOVA - A Study to Evaluate Safety, Tolerability, PK and PD of AGMB-129 in Patients With Fibrostenotic Crohn's Disease (clinicaltrials.gov) - P2 | N=103 | Active, not recruiting | Sponsor: Agomab Spain S.L. | Recruiting ➔ Active, not recruiting | Trial completion date: Dec 2026 ➔ Sep 2026 | Trial primary completion date: Dec 2026 ➔ Sep 2026

Enrollment closed • Trial completion date • Trial primary completion date • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease

Intestinal fibrosis in Crohn's disease : towards new therapeutic options? (PubMed, Rev Med Liege) - "New therapeutic strategies are emerging, including TL1A inhibitors (duvakitug, tulisokibart), an ALK5 inhibitor (AGMB-129), and targeted AGR2 therapies (TH-009). Additionally, mesenchymal stem cells are being investigated in our hospital center in combination with endoscopic balloon dilation, aiming to assess their therapeutic potential. The development of effective anti-fibrotic therapies remains a critical medical need to improve the management of intestinal strictures and reduce the need for invasive procedures in Crohn's disease."

Journal • Review • Crohn's disease • Fibrosis • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • AGR2 • TGFBR1

Agomab Announces Positive Topline Phase 2a Interim Results for AGMB-129 in Fibrostenosing Crohn’s Disease (Businesswire) - P2a | N=90 | STENOVA (NCT05843578) | Sponsor: Agomab Spain S.L. | "STENOVA clinical trial on track to report full results in the fourth quarter of 2025....Agomab Therapeutics NV...today announced positive interim results from 44 patients completing treatment in the ongoing STENOVA1 Phase 2a clinical trial for AGMB-129, an oral gastro-intestinal (GI)-restricted small molecule inhibitor of ALK5 (TGF-β RI or ALK5) for the potential treatment of Fibrostenosing Crohn’s Disease (FSCD)....The primary endpoints are the safety and tolerability of AGMB-129 in FSCD patients....The company has also initiated the open-label treatment extension of the STENOVA study with AGMB-129. Study participants who have completed the double-blind 12-week treatment period are eligible to participate and can receive treatment for up to an additional 48 weeks."

P2a data • Crohn's disease

AGMB-129, an investigational ALK5 inhibitor for the treatment of Fibrostenosing Crohn’s Disease (FSCD), shows gastrointestinal (GI) restricted pharmacokinetics (PK) and a favorable safety profile in healthy subjects (ECCO-IBD 2025) - P2 | "AGMB-129 was safe and well-tolerated at all dosages and is the first ALK5 inhibitor suitable for continuous daily dosing in humans. The STENOVA Ph2a study of AGMB-129 up to 200 mg BID in symptomatic FSCD is ongoing (NCT05843578)."

Clinical • PK/PD data • Crohn's disease • Immunology • Inflammatory Bowel Disease • TGFB1 • TGFBR1

AGMB-129-C102: STENOVA - A Study to Evaluate Safety, Tolerability, PK and PD of AGMB-129 in Patients With Fibrostenotic Crohn's Disease (clinicaltrials.gov) - P2 | N=90 | Recruiting | Sponsor: Agomab Spain S.L. | Trial completion date: Dec 2025 ➔ Dec 2026 | Trial primary completion date: Dec 2025 ➔ Dec 2026

Trial completion date • Trial primary completion date • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease

Agomab Announces $89 Million Series D Financing to Support Broad Fibrosis-Focused Pipeline (Businesswire) - "The proceeds from the Series D will be used to further advance the ongoing clinical development of Agomab’s lead candidate, AGMB-129, a gut-restricted oral small molecule inhibitor of ALK5 (TGFβ1R), in patients with fibrostenosing Crohn’s disease (FSCD). Interim data from the Phase 2a STENOVA trial are expected in the first quarter of 2025. In addition, proceeds will be used to advance the clinical development for AGMB-447…as well as initial clinical development of AGMB-101…"

Financing • P2a data • Crohn's disease • Immunology • Inflammation • Inflammatory Bowel Disease