ACADIA Pharmaceuticals and Neuren Pharmaceuticals Announce Exclusive License Agreement

ACADIA Pharmaceuticals (NASDAQ:ACAD) and Neuren Pharmaceuticals (ASX:NEU) announced today that they have entered into an exclusive North American License Agreement for the development and commercialization of trofinetide for Rett syndrome and other indications. Neuren retains rights to develop and commercialize trofinetide for all indications outside of North America.

As quoted in the press release:

ACADIA plans to initiate a Phase 3 randomized, double-blind placebo-controlled study evaluating trofinetide in the second half of 2019 following completion of additional manufacturing activities. This study will evaluate trofinetide and placebo in approximately 180 girls with Rett syndrome and will measure the Rett Syndrome Behavior Questionnaire (RSBQ), a caregiver assessment, and the Clinical Global Impression of Improvement (CGI-I), a physician assessment, as co-primary efficacy endpoints.

“A potential treatment for Rett syndrome is a perfect fit with ACADIA’s mission to develop novel therapies to improve the lives of patients with central nervous system disorders,” said Serge Stankovic, M.D., M.S.P.H, Executive Vice President, Head of Research and Development at ACADIA. “Today there are no approved treatments for the girls and women suffering from Rett syndrome. We look forward to initiating a Phase 3 study in the second half of 2019 to further explore the potential benefits of trofinetide for patients and their caregivers.”

Click here to read the full press release.