AGMB-447 / AgomAb Therapeutics - LARVOL DELTA

AGMB-447, an inhaled ALK5 inhibitor in development for the treatment of idiopathic pulmonary fibrosis, demonstrates safety, tolerability, lung-restricted exposure, and target engagement in healthy subjects (ERS 2026) - "Conclusions Inhalation of AGMB-447 was considered safe and well tolerated in healthy subjects. The observed lung‑restricted profile, low systemic exposure, and local target engagement indicate that AGMB-447 has the potential to safely target the TGF-β pathway in the lungs."

Clinical • First-in-human • Cough • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases • SMAD3 • TGFB1 • TGFBR1

Agomab Announces…Design of Phase 2 INSPIRIA Study (GlobeNewswire) - "INSPIRIA is a 24-week Phase 2, randomized, double-blind, placebo-controlled study in approximately 120 patients with confirmed IPF. Patients will be randomized 2:1 to receive AGMB-447 4 mg twice daily or placebo, administered by inhalation on top of standard of care. The study is designed to evaluate the safety, pharmacokinetics and efficacy of AGMB-447 in IPF patients. The primary endpoint will be the change from baseline in forced vital capacity at Week 24. The CTA for INSPIRIA has been submitted, and the study is anticipated to begin in the second half of 2026 across a large European site network."

New P2 trial • Idiopathic Pulmonary Fibrosis

Agomab Announces Positive Phase 1 Results for AGMB-447 in Patients with Idiopathic Pulmonary Fibrosis… (GlobeNewswire) - "A total of 10 IPF patients were included in Part C. In line with the data in healthy participants reported previously, AGMB-447 was observed to have a generally favorable safety and tolerability profile in IPF patients at 4.5 mg BID. While a higher incidence of adverse events was reported at 6 mg BID, no new specific safety signals were identified, and no systemic safety signals were detected at any dose. The most frequently reported adverse events were cough and bronchospasm....In IPF patients, pSMAD3 reduction in BAL cells of >50% was achieved at the 4.5 mg BID dose....Agomab intends to present detailed Phase 1 results at a future scientific conference."

P1 data • Idiopathic Pulmonary Fibrosis

First Half 2026 Program Highlights and Anticipated Milestones: AGMB-447 (GlobeNewswire) - "We have enrolled 10 participants in the IPF cohort of the Phase 1b study with AGMB-447. In this cohort, participants receive multiple doses of AGMB-447 or placebo over 14 days. We expect to report topline results from the IPF patient cohort in the coming months. We are on track to initiate a Phase 2 trial with AGMB-447 in IPF in the second half of the year."

New P2 trial • P1 data • Trial status • Idiopathic Pulmonary Fibrosis

Phase I Study to Assess Safety, Tolerability, PK and PD of AGMB-447 in Healthy Participants and Participants With IPF (clinicaltrials.gov) - P1 | N=143 | Completed | Sponsor: Agomab Spain S.L. | Recruiting ➔ Completed

Trial completion • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases

Agomab to Participate in Upcoming Conferences (Yahoo Finance)

Preclinical • Idiopathic Pulmonary Fibrosis

AGMB-447, an inhaled small molecule inhibitor of ALK5 in development for the treatment of IPF (GlobeNewswire) - "We continue to enroll participants in the IPF cohort of the Phase 1b study with AGMB-447. In this cohort, up to 12 participants with IPF will receive multiple doses of AGMB-447 or placebo over 14 days. We have dosed the first participants, and expect to report topline results in the second half of 2026. We received positive scientific advice from the UK Medicines and Healthcare products Regulatory Agency (MHRA), supporting our planned Phase 2 trial in IPF patients. We are on track to initiate a Phase 2 proof-of-concept study with AGMB-447 in IPF in the second half of 2026."

New P2 trial • P1 data • Trial status • Idiopathic Pulmonary Fibrosis

Agomab Receives U.S. Patent for AGMB-447, its Inhaled Lung-restricted Small Molecule Inhibitor of ALK5 in Development for the Treatment of Idiopathic Pulmonary Fibrosis (GlobeNewswire) - "This patent provides intellectual property (IP) protection for AGMB-447 in the U.S. through at least 2041, excluding any potential patent term extensions....'We look forward to the results of the IPF patient cohort of the Phase 1b study later this year'."

P1 data • Patent • Idiopathic Pulmonary Fibrosis

AGMB-447, an Inhaled Lung-Restricted TGFβR1/ALK5 Inhibitor Intended for the Treatment of Idiopathic Pulmonary Fibrosis, Shows Robust Anti-Fibrotic Activity and Target Engagement in Preclinical Species and Healthy Subjects (ATS 2026) - No abstract available

Preclinical • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases • 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

Agomab Announces Positive Phase 1 Interim Results with AGMB-447 in Healthy Participants and Initiation of Idiopathic Pulmonary Fibrosis Cohort (GlobeNewswire) - "Interim data from Phase 1 with single and multiple ascending doses show no safety signals and a generally favorable tolerability profile of AGMB-447 in healthy participants. Pharmacokinetic profile in healthy participants shows low systemic exposure of AGMB-447, with high exposure to the lung. Robust dose-dependent target engagement of ALK5 observed with AGMB-447 in healthy participants....First patients dosed in the Idiopathic Pulmonary Fibrosis cohort of the study....Based on the positive results observed to date, the company plans to initiate a Phase 2 study in IPF patients in 2026. Agomab intends to present detailed Phase 1 results at a future scientific conference."

New P2 trial • P1 data • Trial status • Idiopathic Pulmonary Fibrosis

Phase I Study to Assess Safety, Tolerability, PK and PD of AGMB-447 in Healthy Participants and Participants With IPF (clinicaltrials.gov) - P1 | N=145 | Recruiting | Sponsor: Agomab Spain S.L. | N=107 ➔ 145 | Trial completion date: Dec 2025 ➔ Jun 2026 | Trial primary completion date: Dec 2025 ➔ Jun 2026

Enrollment change • Trial completion date • Trial primary completion date • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases

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

Phase I Study to Assess Safety, Tolerability, PK and PD of AGMB-447 in Healthy Participants and Participants With IPF (clinicaltrials.gov) - P1 | N=107 | Recruiting | Sponsor: Agomab Spain S.L. | N=76 ➔ 107 | Trial completion date: Mar 2025 ➔ Dec 2025 | Trial primary completion date: Mar 2025 ➔ Dec 2025

Enrollment change • Trial completion date • Trial primary completion date • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases

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

Agomab Receives FDA Orphan Drug Designation for AGMB-447 in Idiopathic Pulmonary Fibrosis (Businesswire) - "Agomab Therapeutics NV...announced that it has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for AGMB-447, its inhaled, small molecule inhibitor of ALK5. Agomab is evaluating AGMB-447 as a potential treatment for Idiopathic Pulmonary Fibrosis (IPF) in a Phase 1 clinical trial (NCT06181370)."

Orphan drug • Idiopathic Pulmonary Fibrosis

Orphan Designation: treatment of idiopathic pulmonary fibrosis (FDA) - Date Designated: 05/15/2024

Orphan drug • Idiopathic Pulmonary Fibrosis • Pulmonary Disease • Respiratory Diseases

Phase I Study to Assess Safety, Tolerability, PK and PD of AGMB-447 in Healthy Participants and Participants With IPF (clinicaltrials.gov) - P1 | N=76 | Recruiting | Sponsor: Agomab Spain S.L.

New P1 trial • Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases

Agomab Starts Phase 1 Clinical Study for AGMB-447 in Healthy Subjects and Patients with Idiopathic Pulmonary Fibrosis (Businesswire) - "Agomab Therapeutics NV...today announced that it has dosed the first subject in a first-in-human Phase 1 clinical study of AGMB-447, an inhaled lung-restricted small molecule inhibitor of ALK5 (TGFβRI or ALK5). The study is evaluating AGMB-447 in healthy subjects and in patients with idiopathic pulmonary fibrosis (IPF)....The Phase 1 trial includes a Single Ascending Dose (SAD) and a Multiple Ascending Dose (MAD) evaluation of AGMB-447 in healthy subjects, followed by repeated dosing with AGMB-447 in IPF patients over a two-week treatment period."

Trial status • Idiopathic Pulmonary Fibrosis • Pulmonary Disease • Respiratory Diseases

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

Agomab Therapeutics to Acquire Origo Biopharma (Businesswire) - "Agomab Therapeutics NV (‘Agomab’) announced today that it has entered into a definitive agreement under which it will acquire Origo Biopharma S.L., a Spanish clinical-stage biotechnology company developing organ-restricted small molecule drug candidates targeting the transforming growth factor beta (TGF-β) pathway for the treatment of fibrosis-related disorders....A second program, ORG-447, is a lung-restricted ALK-5-inhibitor, currently in IND-enabling studies, for treatment of idiopathic pulmonary fibrosis."

M&A • Preclinical • Idiopathic Pulmonary Fibrosis • Respiratory Diseases