China’s Green Valley Pharmaceutical company has prematurely ended an FDA approved study on its GV-971 to treat mild to moderate Alzheimer’s disease, says a media report
Company officials attributed the ending of the trial to “multiple negative factors” and Green Valley terminated a global phase 3 trial for its seaweed-derived Alzheimer’s drug oligomannate, or GV-971, the company said in a statement, according to Robert Besser report in Beijing Bulletin today.
Green Valley noted that it stopped the study due to the “global geopolitical situation” and a gloomy biotech capital market, preventing it from raising the funding to support the trial.
The company noted that COVID-19 outbreaks in China slowed the sales of GV-971 domestically.
In 2019, China approved GV-971 for use in treating mild to moderate Alzheimer’s disease.
To win approvals in Western countries, Green Valley began its global phase 3 trial, with an FDA go-ahead in April 2020, just as COVID began to close down much of the world.
Green Valley faced many questions after its initial study was only partially successful, however, continued with a Phase 3 trial which included opening 162 trial sites.
Company officials said that as of April 26, 1,308 patients had been screened for the study and 439 enrolled, including 257 participants in the U.S.
As enrollment in the test increased, Green Valley found itself in need of cash. At the same time, the worldwide Covid outbreak decreased the number of test participants already selected.
Green Valley has informed participants about discontinuing the trial, assisting them in withdrawing from the drug and starting them on standard treatments. Meanwhile, in January the company received permission from the U.S. Federal Drug Administration to begin a phase 2 trial for GV-971 in Parkinson’s disease patients.
Green Valley officials have reiterated that they remain committed to obtaining international approvals for GV-971, saying the global clinical program will start again “when condition permits in the future,” the report in Beijing Bulletin added