Chinese Alzheimer's drugmaker says lack of funding, Covid outbreak forced it to shutter international PhIII
Green Valley Pharma, the Shanghai drugmaker that scored a stunning approval to market an Alzheimer’s drug in China two years ago, has shuttered a Phase III trial that would’ve paved its way to the FDA.
A lack of funding had forced its hand, according to the biotech, which said its commercial sales had withered amid a new Covid-19 outbreak in China. It tried to raise additional financing but was unable to due to “geopolitical circumstances and a chilly capital market for biomedical investments.”
The company issued a press release explaining the early termination in Chinese last Friday, a few days after Endpoints News first reported that the trial had been halted, citing trial sites.
Eric Reiman, a former scientific advisor to Green Valley, told Endpoints he was informed the trial was discontinued “due to unexpected financial challenges related to the Covid-19 pandemic in China.”
The release confirmed his comment and elaborated on the decision.
GV-971, the drug in question, is an oral capsule consisting of an oligosaccharide derived from seaweeds. While researchers had initially thought it may work by altering amyloid beta, Green Valley ultimately proposed that it works through the gut-brain axis, taming down nervous system inflammation through modulating gut microbiota.
Endorsed by some high-profile names in the US, its surprise 2019 approval came at a time Biogen had scrapped two trials for aducanumab, then the foremost Alzheimer’s candidate around the world, before ultimately reversing course and steering it toward a controversial approval. The stunning news out of China sparked a whole gamut of reactions among experts, from cautious optimism to skepticism to bewilderment.
The Phase III study kicked off in October 2020 and was designed to enroll 2,046 patients with mild to moderate Alzheimer’s.
In the end, Green Valley screened 1,308 participants across 11 countries or regions as of April 26, 439 of whom were randomized into the study. Among them were 257 subjects in North America, 118 in Europe and 64 in China.
An independent data safety monitoring board had met earlier this year at the 10% enrollment milestone to review the safety data and concluded that there were no safety risks that would affect the continuation of the trial, the company noted.
However, the domestic outbreak that started in early 2022 had a huge impact on GV-971 sales, which largely went through in-hospital prescription, Green Valley said. Those also coincided with an enrollment spike in other countries — translating to a short-term cash crunch. At the same time, the pandemic made off-line assessment of trial participants difficult, which contributed to a growing dropout rate, all contributing to rising costs and risks.
Right now, the company suggested that it will wind down the trial and focus on the Chinese market. From a statement:
At about 10 million, our country has the world’s largest Alzheimer’s patient community. As the pandemic alleviates, Green Valley will accelerate the work of market and hospital access after GV-971 enters national insurance, and focus our resources on doing well on the existing market. With GV-971 demonstrating treatment benefits on a growing number of patients over the past two or so years on the market, more and more doctors will begin to recognize its unique clinical value, it will be included in authoritative clinical guidelines and expert consensus as well as national insurance. In the future it has the potential to benefit even more Chinese patients. Meanwhile based on our mission of “Only making medicines that humans most long for,” Green Valley will persist in our goal of bringing GV-971 to the international market, and restart international studies of GV-971 when the situation allows, so that this original AD medicine can reach patients around the world.