Swiss Biotech VectiveBio, in partnership with Asahi Kasei Pharma Corporation, have started a Phase 1 Study of Apraglutide. The single-dose study aims to assess pharmacokinetics, pharmacological activity, safety and tolerability in healthy Japanese men and women. The study plays a key role in applying for marketing authorization in Japan.
Based in Basel, VectivBio is a clinical-stage biopharmaceutical company pioneering novel transformational treatments for severe, rare conditions. Its lead product candidate, apraglutide, is a next-generation, long-acting synthetic GLP-2 analog being developed for a range of rare gastrointestinal diseases where GLP-2 can play a central role in addressing disease pathophysiology, including short bowel syndrome with intestinal failure (SBS-IF) and Acute Graft-Versus-Host Disease (aGVHD).
In partnership with Japan-based Asahi Kasei Pharma Corporation, VectivBio has initiated 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 placebo control.
This study is expected to be the only Japan-specific clinical study necessary to file a marketing authorization application in Japan. “The initiation of the Phase 1 study is a significant milestone for VectivBio and Asahi Kasei Pharma as this brings us one step closer to making apraglutide available for SBS-IF patients in Japan,” said Omar Khwaja, MD, Chief Medical Officer of VectivBio.
Strengthening an existing partnership
In March 2022 VectivBio entered into an exclusive licensing agreement with Asahi Kasei Pharma Corporation to develop and commercialize apraglutide, a next-generation, long-acting GLP-2 analog, for the treatment of short bowel syndrome with intestinal failure (SBS-IF), steroid-refractory acute graft-versus-host disease (aGVHD) and future indications in Japan.
VectivBio received an upfront cash payment of approximately $30 million ($5 million of which was the first instalment of development cost-sharing) 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.
(Press release/RAN)
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