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Vectivbio, Asahi Kasei commence Phase 1 study of apraglutide
The Fly

Vectivbio, Asahi Kasei commence Phase 1 study of apraglutide

VectivBio Holding and Asahi Kasei Pharma announced the start of a Phase 1 study investigating the pharmacokinetics, pharmacological action, safety, and tolerability of apraglutide when a single subcutaneous dose is given to healthy Japanese adult men and women. Pharmacological actions and safety will be investigated by comparison with a placebo control. In March 2022 VectivBio entered into an exclusive licensing agreement with Asahi Kasei Pharma to develop and commercialize apraglutide, a next-generation, long-acting GLP-2 analog, for the treatment of short bowel syndrome with intestinal failure, steroid-refractory acute graft-versus-host disease and future indications in Japan. VectivBio received an upfront cash payment of approximately $30 million and is eligible for up to approximately $170 million in further development activities and milestone payments upon the achievement of certain development, regulatory and commercial milestone events. VectivBio is also eligible to receive tiered, double-digit, escalating royalties on sales of apraglutide in Japan. VectivBio is conducting the STARS Phase 3 global program studying apraglutide in patients with SBS-IF with 93 sites in 18 countries, including multiple sites in Japan. This newly initiated Phase 1 study in healthy Japanese volunteers, conducted by Asahi Kasei Pharma, is expected to be the only Japan-specific clinical study necessary to file a marketing authorization application in Japan.

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