Agomab’s AGMB-447 inhaled ALK5 inhibitor gets orphan drug designation from the FDA

According to Agomab Therapeutics, the company’s AGMB-447 inhaled ALK5 inhibitor has received orphan drug designation from the FDA for the treatment of idiopathic pulmonary fibrosis (IPF). Agomab initiated a Phase 1 trial of AGMB-447 in December 2023.

Agomab Chief Medical Officer Philippe Wiesel commented, “Receiving orphan drug designation from the FDA provides further support that AGMB-447’s mechanism of action has the potential to achieve meaningful therapeutic benefits to IPF patients. As we progress through our ongoing first-in-human Phase 1 trial, we look forward to evaluating the data from the single ascending dose and multiple ascending dose evaluation of AGMB-447 in healthy subjects and IPF patients.”

Read the Agomab Therapeutics press release.

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