Agomab Therapeutics has announced that the final part of a Phase 1 study of its AGMB-447 inhaled ALK5 inhibitor, which enrolled patients with idiopathic pulmonary fibrosis, demonstrated “a generally favorable safety and tolerability profile” in those patients at the lowest dose tested. The Phase 1 study was initiated in 2023, and Agomab released data from the portions of the study in healthy volunteers at the beginning of 2026.
The company also said that it has submitted a clinical trial application for a Phase 2 study that it intends to initiate before the end of 2026. According to Agomab, the planned 24-week Phase 2 INSPIRIA study is expected to enroll approximately 120 IPF patients who will receive either 4 mg doses of nebulized of AGMB-447 twice daily or inhaled placebo twice daily, in addition to standard of care.
The 10 IPF patients in Part C of the Phase 1 study received nebulized AGMB-447 twice a day over 14 days at doses ranging from 4.5 mg to 6 mg. According to Agomab, cough and bronchospasm were the most common adverse events, mostly occurring around the time of inhalation. The company says that PK data observed in IPF patients were similar to those from the healthy volunteer portion of the trial, with high exposure in the lung and low systemic exposure.
Agomab Chief Medical Officer Philippe Wiesel commented, “We are very pleased with the Phase 1 results of AGMB-447 in patients with IPF announced today. In line with the positive interim data in healthy participants announced earlier this year, the data indicated a generally favorable safety, tolerability and PK profile of AGMB-447 and provided proof-ofmechanism of TGFβ/ALK5 inhibition in the lungs of IPF patients. We believe that by blocking the TGFβ/ALK5 pathway locally in the lung, AGMB447 has the potential to offer a potent anti-fibrotic therapy to IPF patients. The extensive data collected in our broad Phase 1 program supports the initiation of our Phase 2 INSPIRIA study later this year.”
Read the Agomab Therapeutics press release
