Astria joins Kaken to bring new HAE therapy navenibart to Japan
Phase 3 clinical trial in the works to further evaluate therapy's safety, efficacy
Kaken Pharmaceutical has secured the rights to develop and commercialize navenibart, an investigational treatment for hereditary angioedema (HAE), in Japan.
Kaken will pay $16 million as part of an agreement with navenibart developer Astria Therapeutics that includes another $16 million if development and sales milestones are met. Astria is also entitled to royalties on sales of the therapy and partial reimbursement on the costs of clinical trials.
“We are thrilled to partner with Kaken for the development and commercialization of navenibart in Japan, which advances our strategy to enable broad access to navenibart globally,” Jill C. Milne, PhD, CEO of Astria, said in a company press release.
Hiroyuki Horiuchi, president and representative director of Kaken, said the agreement “supports our strategy of providing therapies that address unmet medical needs in the Japanese community.”
“We believe that navenibart is a complementary fit with our HAE portfolio, providing patients in Japan with the potential for low-burden treatments to better manage their disease,” Horiuchi said.
How does navenibart treat swelling attacks?
In HAE, swelling attacks are driven by the overproduction of the signaling molecule bradykinin. Navenibart is an antibody-based therapy that’s made to block kallikrein, an enzyme involved in producing bradykinin. Given by injections under the skin, it’s designed to prevent or reduce the frequency of HAE swelling attacks.
“As a physician that treats people with HAE, I am incredibly excited about the potential of a preventative therapy with navenibart’s profile,” said Michihiro Hide, MD, PhD, president of the Hiroshima City Hospital Organization. “I believe that navenibart could have a significant impact on the lives of HAE patients in Japan where people living with HAE are seeking options that allow them to be protected from their HAE attacks with very low treatment burden.”
Data from the a Phase 1b/2 trial ALPHA-STAR (NCT05695248) indicate navenibart reduced monthly swelling attack rates by up to 95%, a reduction that was sustained over nearly a year of treatment in the open-label extension study ALPHA-SOLAR (NCT06007677).
Astria is sponsoring a Phase 3 clinical trial called ALPHA-ORBIT (NCT06842823) to further evaluate the therapy’s safety and efficacy. It looks to enroll about 145 people, ages 12 and older, with HAE types 1 or 2. To be eligible, participants must have had at least two swelling attacks during the trial’s run-in period. The study’s participants will be randomly assigned to injections of a placebo or navenibart every three or six months, the main goal being to assess how treatment impacts attack rates after six months. The trial is recruiting participants at more than a dozen sites in the U.S. and Canada.
As part of the new agreement, Kaken will provide support for the ALPHA-ORBIT study in Japan, according to Astria. Kaken also will be responsible for regulatory submissions there.
“In addition to our shared values that put patients first, Kaken brings strong relationships with the Japanese medical community that we believe will support both our Phase 3 ALPHA-ORBIT trial as well as the potential commercialization of navenibart in the future,” Milne said.
About the Author
