According to the terms of the strategic collaboration, OnKai will use five AI models to form enrollment plans for clinical trials run by Galmed, starting with trials of its small molecule drug Aramchol to treat the rare disease primary sclerosing cholangitis (PSC). These trials include a phase 2a study beginning in late 2023 and a phase 2/3 trial confirmatory trial following that.
PSC is a chronic disease where bile ducts become fibrotic (scarred) and become narrower. This eventually leads to bile backing up into the liver and damaging the organ, sometimes leading to cirrhosis. Aramchol is designed to prevent fibrosis and could become the first approved treatment for the disease.
The first AI model to be used by OnKai in the collaboration is named TrialBridge. The platform is designed to connect free clinics and their patients with specialist centers, improving access of the patients to healthcare and clinical trials.
During the clinical trials, local clinics will receive the tools and fair compensation to accompany their patients. The trials will also be supported by OnKai's Smart-Grid AI Platform, which is designed to connect free and affordable clinics with other clinics and to the resources and solutions they need.
The partnership agreement was first forged between Galmed and OnKai in May 2023. This involved Galmed gaining a stake in OnKai via a $3 million investment, leading a $6 million investment round in the U.S. company.
“The application of OnKai's AI platform is still emerging but potentially disruptive for the conduct of clinical trials,” stated Allen Baharaff, CEO and President of Galmed Pharmaceuticals. “Not only does this partnership allow us to include a diverse population in our trials, but it is also expected that it will result in faster approval and better site performance."
Many communities in the U.S. are underserved by healthcare professionals and this shortage is expected to grow over the next 10 years, particularly in rural communities and deprived urban areas. OnKai’s AI technology could allow the pharma and biotech industry to more easily provide a potential pool of 80 million patients in underserved communities with experimental treatments in clinical trials, according to Galmed’s public release in May.
In the last few years, Galmed has been developing Aramchol for the treatment of the chronic liver disease nonalcoholic steatohepatitis (NASH), which currently lacks any treatments approved by the U.S. Food and Drug Administration (FDA). The treatment is currently in phase 3 development for the treatment of NASH.
In January 2023, Galmed released data from the open-label part of a phase 3 trial supporting the anti-fibrotic effects of Aramchol in patients with NASH. In a public release, the company said that it was preparing to discuss its primary endpoints with the U.S. FDA and currently has no plans to continue the double-blinded part of the same phase 3 trial.