Canton Township-based MMS Holdings, a data-focused contract research organization, has announced a successful collaboration with Shanghai’s Green Valley Pharmaceutical Co. to aid in the treatment of Alzheimer’s.
The partnership resulted in U.S. Food and Drug Administration approval of an investigational new drug application for the GV-971 international multi-center Phase 3 clinical study in the treatment of patients with Alzheimer’s disease.
Building on Green Valley’s successful application for GV-971 as the first Alzheimer’s drug approved in China in 17 years, MMS and Green Valley partnered to support an additional Phase 3 study and development plan to meet the requirements of U.S. regulations. Green Valley now can begin a large-scale Phase 3 clinical trial in the U.S., which seeks to enroll more than 2,000 patients with mild to moderate Alzheimer’s across North America, Europe, and Asia.
“MMS has a well-established history within neuroscience and strategic support of these indications is a tradition in our portfolio,” says Uma Sharma, chief scientific officer at MMS. “We are proud to see many international sponsors benefitting from this expertise in recent times.”
GV-971 is an orally administered mixture of acidic linear oligosaccharides derived from marine brown algae. Preclinical studies on its mechanism of action show that GV-971 improved the cognitive function by inhibiting neuroinflammation through the targeting of dysbiosis of gut microbiota in AD transgenic mouse models.
In a completed 36-week Phase 3 clinical trial conducted in China, GV-971 showed rapid initial gains in cognition with sustained improvement across the study in mild-to-moderate Alzheimer’s patients that was statistically significant comparing the placebo. Green Valley’s new therapy was approved by the National Medical Products Administration and launched in China last year.
“With its novel mechanism of action and positive results in one Phase 3 study, MMS is excited to be part of a program that is advancing new therapies in an indication that has been relentlessly challenging over the last few decades, and we thank Green Valley for their continued trust in us,” says Ben Kaspar, global regulatory affairs manager at MMS.
The Phase 3 clinical trial is slated to be completed in 2024, and the new drug registration application submission is expected by 2025.
MMS serves the pharmaceutical, biotech, and medical device industries. Green Valley was founded in 1997.