VectivBio and Asahi Kasei Pharma Announce the Start of a Phase 1 Study of Apraglutide in Japan
VectivBio, a clinical-stage biopharmaceutical company pioneering novel transformational treatments for severe rare conditions, and Asahi Kasei Pharma have 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 (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 installment 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. 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.
“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.
- Eloxx Pharmaceuticals Announces Final Data Assessment from Phase 2 Combination Clinical Trial of ELX-02 in Class 1 Cystic Fibrosis Patients Read more
- Verge Genomics Announces Positive Safety and Tolerability Data from the Phase 1 Clinical Trial of VRG50635, a Potential Best-in-Class Therapeutic for All Forms of ALS Read more
- DEM BioPharma Appoints Wendy Young, Ph.D., to Scientific Advisory Board Read more
- Confo Therapeutics Enters into Research Collaboration for GPCR-Targeting Antibody Discovery with AbCellera Read more
- Vyriad Announces Expansion of T-Cell Lymphoma Trial at Mayo Clinic Read more