Agomab’ AGMB-129 Receives the US FDA’s Fast Track Designation for Fibrostenosing Crohn’s Disease
Shots:
- The US FDA has granted FTD to AGMB-129 for Fibrostenosing Crohn’s Disease (FSCD). The company also announced the initiation of the P-IIa trial (STENOVA) evaluating AGMB-129, an oral GI-restricted small molecule inhibitor of ALK5 in 36 patients with symptomatic FSCD across the USA, Canada, and EU
- The 1EPs of the study are the safety and tolerability of AGMB-129 & 2EPs incl. the PK and target engagement at the site of the ileal strictures
- In the P-I trial, single- and multiple-dose AGMB-129 was well-tolerated at all doses tested & confirmed that the GI-restricted mechanism operates efficiently in humans by showing high local exposure to AGMB-129 in the ileum
Ref: Businesswire | Image: Agomab
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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.
