VectivBio and Asahi Kasei Pharma Announce the Start of a Phase 1 Study of Apraglutide in Japan
- Category: Proteins and Peptides
- Published on Tuesday, 14 March 2023 09:34
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Single-dose study to assess pharmacokinetics, pharmacological activity, safety and tolerability in healthy Japanese men and women
BASEL, Switzerland I March 13, 2023 I VectivBio Holding AG (“VectivBio”) (Nasdaq: VECT),), a clinical-stage biopharmaceutical company pioneering novel transformational treatments for severe rare conditions, and Asahi Kasei Pharma Corporation (“Asahi Kasei Pharma”) today 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.
* Using exchange rates in effect at the time of Agreement’s effective date.
Apraglutide is an investigational new drug that 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).
About The STARS Phase 3 Program
STARS is a pivotal, global Phase 3 study enrolling approximately 144 patients with SBS-IF stratified 50/50 for CIC and stoma, with patients being evaluated over 48 weeks and 24 weeks respectively. This stratification will allow for the evaluation of anatomy-specific key secondary endpoints. Patients are randomized 2:1 for either once-weekly-apraglutide or placebo. The study includes an improved PS weaning algorithm tailored to remnant bowel anatomy to enhance signal detection. STARS is designed to establish a new standard of care for all patients with SBS-IF and to tailor apraglutide treatment to patients with distinct remnant bowel anatomy. The Phase 3 study is being conducted globally in 18 countries and over 80 sites.
About VectivBio AG
VectivBio is a global clinical-stage biotechnology company focused on transforming and improving the lives of patients with severe rare conditions. 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).
VectivBio is also advancing its modular, small molecule CoMET platform to address a broad range of previously undruggable Inherited Metabolic Diseases (IMDs). CoMET leverages innovative chemistry, based on a proprietary stabilized pantetheine backbone, to restore fundamental cellular metabolism in pediatric populations with IMDs characterized by a deficit of energy metabolism caused by the depletion of functional Coenzyme A (“CoA”). Candidates from the CoMET platform are initially being evaluated in methylmalonic acidemia (MMA), propionic acidemia (PA), and other organic acidemias.
About Asahi Kasei Pharma
In accordance with the Asahi Kasei Pharma Mission "To sincerely care for each individual life and solve their unmet medical needs with a wealth of ideas and solid science," Asahi Kasei Pharma operates pharmaceutical and diagnostic businesses in the Health Care Business Unit of the Asahi Kasei Group. For more information, please visit https://www.asahikasei-pharma.co.jp/en/.
SOURCE: Asahi Kasei Pharma