Scoop: Green Valley's seaweed-derived Alzheimer's drug, approved in China, is halted in PhIII study

11 May 2022
endpts.com
Small molecular drug
A Phase III study of a seaweed-derived Alzheimer’s drug, conditionally approved in China in November 2019, has been halted, five trial sites have confirmed to Endpoints News.
Shanghai-based Green Valley Pharmaceuticals’ oligomannate, or GV-971, was in a late-stage Alzheimer’s study dubbed “Green Memory,” but the trial was halted due to supply chain issues, according to four of the sites. One site said it was not supply chain-related.
Eric Reiman, a former scientific advisor to Green Valley, said he was informed the trial was discontinued “due to unexpected financial challenges related to the COVID-19 Pandemic in China.”
“Based on the information that was shared with us, the advisors were not aware of any treatment-related safety issues,” Reiman said in an email to Endpoints. He is also executive director of Banner Alzheimer’s Institute, which is listed as one of the study’s trial sites on clinicaltrials.gov.
The trial was halted at one site in early April, another about two weeks ago and others “several” and “a couple” weeks ago. One trial site said they received a calendar invite from the company for tomorrow. “Shanghai is not in a happy place,” one of the trial sites said, citing the Covid-19 lockdowns currently taking place in the city.
Endpoints has reached out to multiple phone numbers and emails associated with Green Valley and will update accordingly. At the time of its IND clearance in April 2020, Green Valley said it would work with IQVIA on the trial. A spokesperson for the CRO told Endpoints in an emailed statement: “It’s our corporate policy to defer all study questions to the respective study sponsors.”
The news comes after CMO Samuel Agus left his post last month, according to his LinkedIn profile.
The study kicked off in October 2020 and had expected to enroll 2,046 patients with mild to moderate Alzheimer’s. At the time of the IND clearance news, Green Valley said it planned to wrap up the trial in 2024 and submit an NDA by 2025. In January, the biotech said the trial was now slated for completion by 2025 and that it had screened 949 patients and had 292 randomized, thus far. At that time, 154 clinical centers in 10 countries and regions had been activated.
Green Valley has described the drug as: “Being the world’s first AD drug that targets the gut-brain axis, GV-971 reduces peripheral and central inflammation by reconditioning the gut microbiota and inhibiting the abnormal balance of gut microbiota-derived metabolites.”
China’s regulators conditionally approved the drug in November 2019, sending shockwaves into the Alzheimer’s drug development world as there hadn’t been a new medicine for the memory-robbing disease in nearly two decades. But experts were “cautiously optimistic” following the nod.
Related:Alzheimer's breakthrough? Not so fast — experts poke holes in data underlying China's surprise approval
“The other scientific advisors and I were excited about the chance to help the company design a rigorous global Phase 3 clinical trial. We were interested in the drug’s potentially novel mechanism of action, the initial basic science and clinical trial findings from China, the chance to clarify the drug’s efficacy, and potential implications for the role of the microbiome in the development and treatment of Alzheimer’s disease,” Reiman told Endpoints.
The drug was included in China’s national reimbursement drug list late last year, Green Valley said in December 2021, reducing the monthly medication cost from RMB 3,580 ($531) to RMB 1,184 ($175).
The FDA also cleared an IND for a Phase II study of the drug in patients with early-stage Parkinson’s, Green Valley said in January. That trial is expected to include 300 patients at 30 centers in North America and Asia-Pacific over the course of a 36-week study.
The news comes as Biogen and Eisai said Monday that they completed the submission for their second Alzheimer’s treatment, dubbed lecanemab, and as Eli Lilly works on its application for its drug donanemab.
Green Valley was founded in 1997 and employs 1,500 people, according to the company’s website.
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