On 13 May, the Shanghai-based pharmaceutical company, Green Valley, announced the early termination of the global, multi-center Phase III trial of their investigational drug, GV-971 (also known as Sodium Oligomannate). Following on from approval of GV-971 by China’s National Medical Products Administration in November 2019, Green Valley had initiated a Phase III trial of the drug in April 2020, aiming to use the data from this global, multi-center trial to complete their Investigational New Drug submission to the US Food and Drug Administration (FDA). GV-971 is a small molecule drug derived from seaweed, purported to reduce brain inflammation by acting on the gut microbiome, and is taken orally in capsule form. At the time of Green Valley’s announcement, the Phase III Green Memory trial had screened 1,308 participants from 162 clinical centers around the world, randomising 439 participants from North America, Europe and China.
In their press release announcing termination of the trial, Green Valley cited funding concerns linked to low sales during the pandemic on the one hand, coupled with accelerating recruitment rates and increasing trial costs on the other. In addition, Green Valley highlighted elevated dropout rates due to the pandemic, as well as challenges completing the regular cognitive assessments required for participant follow-up. Green Valley are now in discussions with regulatory agencies, clinical centers, investigators and participants to minimise the negative impacts of trial termination, and will focus primarily on accelerating and expanding access to GV-971 for the Chinese market.