AGMB-129 / AgomAb Therapeutics - LARVOL DELTA

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

Relative Bioavailability and Effect of Food Study With AGMB-129 in Healthy Participants (clinicaltrials.gov) - P1 | N=25 | Completed | Sponsor: Agomab Spain S.L. | Active, not recruiting ➔ Completed

Trial completion

Relative Bioavailability and Effect of Food Study With AGMB-129 in Healthy Participants (clinicaltrials.gov) - P1 | N=24 | Active, not recruiting | Sponsor: Agomab Spain S.L.

New P1 trial

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. | N=36 ➔ 90 | Trial completion date: Dec 2024 ➔ Dec 2025 | Trial primary completion date: Dec 2024 ➔ Dec 2025

Enrollment change • Trial completion date • Trial primary completion date • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel 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=36 | Recruiting | Sponsor: Agomab Spain S.L.

Trial completion date • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel 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=36 | Recruiting | Sponsor: Agomab Spain S.L. | Phase classification: P2a ➔ P2

Phase classification • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease

Agomab Receives FDA Fast Track Designation for AGMB-129 in Fibrostenosing Crohn’s Disease and Starts STENOVA Phase 2a Clinical Trial (Businesswire) - "Agomab Therapeutics NV...today announced that it received Fast Track Designation from the U.S. Food and Drug Administration (FDA) for AGMB-129 for the potential treatment of Fibrostenosing Crohn’s Disease (FSCD). In addition, Agomab has initiated its STENOVA Phase 2a clinical trial evaluating AGMB-129, an oral gastro-intestinal (GI)-restricted small molecule inhibitor of ALK5 (TGF-βRI or ALK5), in patients with symptomatic FSCD....The primary endpoints are the safety and tolerability of AGMB-129 in FSCD patients. Secondary endpoints include the pharmacokinetics and target engagement at the site of the ileal strictures."

Fast track designation • Trial status • Crohn's disease • Inflammation

Agomab Raises $100 Million Series C to Advance Fibrosis-focused Pipeline (Businesswire) - "Proceeds will support clinical Phase 2 stage lead candidate AGMB-129 for Fibrostenosing Crohn’s Disease and the development of a highly innovative pipeline of anti-fibrotic and regenerative therapies, including AGMB-447 for idiopathic pulmonary fibrosis and AGMB-101 and AGMB-102 for inflammatory and fibrotic indications...Agomab Therapeutics NV...announced the closing of a $100 million (€94.9 million) Series C financing round led by Fidelity Management & Research Company, with participation from new investors EQT Life Sciences (EQT), Canaan, Dawn Biopharma, a platform controlled by KKR, and existing investors."

Financing • Crohn's disease • Idiopathic Pulmonary Fibrosis • Immunology • Inflammatory Bowel Disease

Drug-Drug Interaction Study With AGMB-129 and Midazolam in Healthy Participants (clinicaltrials.gov) - P1 | N=14 | Completed | Sponsor: Agomab Spain S.L. | Active, not recruiting ➔ Completed

Trial completion

STENOVA - A Study to Evaluate Safety, Tolerability, PK and PD of AGMB-129 in Patients With Fibrostenotic Crohn's Disease (clinicaltrials.gov) - P2a | N=36 | Recruiting | Sponsor: Agomab Spain S.L. | Not yet recruiting ➔ Recruiting

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

Drug-Drug Interaction Study With AGMB-129 and Midazolam in Healthy Participants (clinicaltrials.gov) - P1 | N=14 | Active, not recruiting | Sponsor: Agomab Spain S.L. | Recruiting ➔ Active, not recruiting

Enrollment closed

Drug-Drug Interaction Study With AGMB-129 and Midazolam in Healthy Participants (clinicaltrials.gov) - P1 | N=14 | Recruiting | Sponsor: Agomab Spain S.L.

New P1 trial

A Study to Evaluate Safety, Tolerability, PK and PD of AGMB-129 in Patients With Fibrostenotic Crohn's Disease (clinicaltrials.gov) - P2a | N=36 | Not yet recruiting | Sponsor: Agomab Spain S.L.

New P2a trial • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease

Agomab Reports Positive Phase 1 Results with AGMB-129, a GI-restricted ALK5 Inhibitor for Fibrostenosing Crohn’s Disease (Businesswire) - P1 | N=81 | NCT04933565 | Sponsor: Origo Biopharma | "Agomab Therapeutics NV...today announced positive clinical results from its Phase 1 study evaluating AGMB-129...intended for the treatment of Fibrostenosing Crohn’s Disease (FSCD)....AGMB-129 was well-tolerated at all doses tested. The incidence and intensity of adverse events were similar across all dose cohorts including the placebo cohort. No drug-related safety signal or dose-limiting toxicities were identified. The favorable safety profile from the Phase 1 study supports the evaluation of AGMB-129 in a planned global Phase 2a study in patients with FSCD. Plasma PK analyses showed no clinically relevant systemic exposure, whereas biopsies of the ileum showed high local concentrations of AGMB-129, confirming that the GI-restriction mechanism can operate efficiently in humans."

P1 data • Crohn's disease • Immunology • Inflammatory Bowel Disease

First in Human Study of ORG-129 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=81 | Completed | Sponsor: Origo Biopharma | Active, not recruiting ➔ Completed

Trial completion

First in Human Study of ORG-129 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=80 | Active, not recruiting | Sponsor: Origo Biopharma | Recruiting ➔ Active, not recruiting | N=56 ➔ 80

Enrollment change • Enrollment closed

First in Human Study of ORG-129 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=56 | Recruiting | Sponsor: Origo Biopharma | Trial completion date: Sep 2022 ➔ Jan 2023 | Trial primary completion date: Aug 2022 ➔ Dec 2022

Trial completion date • Trial primary completion date

First in Human Study of ORG-129 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=56 | Recruiting | Sponsor: Origo Biopharma | Trial completion date: Mar 2022 ➔ Sep 2022 | Trial primary completion date: Feb 2022 ➔ Aug 2022

Trial completion date • Trial primary completion date