Agomab Announces Positive Phase 1 Results for AGMB-447 in Patients with Idiopathic Pulmonary Fibrosis and Design of Phase 2 INSPIRIA Study
Agomab Therapeutics reported positive Phase 1 results for AGMB-447, its inhaled lung-restricted ALK5 (TGFβR1) inhibitor, in IPF patients: generally favorable safety and tolerability, low systemic with high pulmonary exposure, and >50% pSMAD3 reduction in BAL cells at 4.5 mg twice daily, indicating robust target engagement in the 10-patient cohort. The company also unveiled INSPIRIA, a 24-week Phase 2 study of approximately 120 IPF patients randomized 2:1 to AGMB-447 4 mg twice daily or placebo on top of standard of care, with change from baseline in forced vital capacity at Week 24 as the primary endpoint.
Key figures
- Drug Name
- AGMB-447
- Phase Of Trial
- Phase 1 (completed); Phase 2 INSPIRIA planned
- Bal exposure
- above IC(90) for at least 6 hours and above IC(50) for 24 hours post-inhalation at 4.5 mg BID
- Phase2 start
- second half of 2026, large European site network; CTA submitted
- Phase2 duration
- 24 weeks
- Phase2 patients
- approximately 120
- Psmad3 reduction
- >50% in BAL cells at 4.5 mg BID
- Phase2 study name
- INSPIRIA
- Phase1 ipf patients
- 10
- Phase2 randomization
- 2:1 to AGMB-447 4 mg twice daily or placebo on top of standard of care
- Ipf patient population
- approximately 255,000 patients in U.S., Japan, and EU4+UK
- Phase2 primary endpoint
- change from baseline in forced vital capacity at Week 24
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