Agomab reports positive Phase 1 data for inhaled IPF drug AGMB-447, plans Phase 2

Agomab Therapeutics NV announced on September 14, 2026 positive results from a Phase 1 study of AGMB-447, an inhaled, lung-restricted small molecule inhibitor of ALK5, in patients with Idiopathic Pulmonary Fibrosis (IPF).

The three-part Phase 1 trial tested single and multiple ascending doses in healthy participants and a multiple-dose arm in IPF patients. Ten IPF patients were included in Part C, and the drug showed a generally favorable safety and tolerability profile at 4.5 mg twice daily, consistent with prior results in healthy volunteers.¹ A higher rate of adverse events occurred at 6 mg twice daily, though no new safety concerns emerged and none of the safety signals appeared to affect the body beyond the lungs at any dose tested; cough and bronchospasm were the most common side effects.¹ Cough episodes were brief and largely occurred during inhalation, and the drug's disease-related cough did not worsen over the 14-day dosing period at any dose.¹

On pharmacokinetics, the drug showed low exposure in the bloodstream but high exposure in the lungs of IPF patients, and the 4.5 mg twice-daily dose kept bronchoalveolar lavage fluid levels above IC90 for at least six hours and above IC50 for 24 hours, matching results seen in healthy participants.¹ Target engagement was also confirmed, with more than 50% reduction in pSMAD3 in lavage cells at the 4.5 mg twice-daily dose.¹

Agomab has designed a Phase 2 study named INSPIRIA. The 24-week, randomized, double-blind, placebo-controlled trial will enroll about 120 confirmed IPF patients, randomized 2:1 to receive AGMB-447 at 4 mg twice daily or placebo by inhalation, added to standard of care.¹ The primary endpoint is change from baseline in forced vital capacity at Week 24.¹ The clinical trial application has been submitted, and the study is expected to begin in the second half of 2026 across a large European site network.¹