Galmed to Employ Onkai’s Disruptive AI in Its Planned Phase 2A Clinical Trial in PSC

Galmed Pharmaceuticals, a clinical-stage biopharmaceutical company for liver, metabolic and fibrotic diseases, is delighted to announce the first step in its strategic partnership with OnKai, where OnKai will apply its artificial intelligence (AI), models for enrollment and execution of clinical trials in underserved communities, starting with Galmed’s innovative Primary Sclerosing Cholangitis (PSC) clinical development program.

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PSC is a rare, severe, chronic disease where progression is predominantly determined by biliary fibrosis. There are currently no approved drugs for the treatment of the disease, which gradually progresses to cirrhosis, often requiring liver transplantation. Aramchol has been shown to have anti-fibrotic effects in pre-clinical models in NASH idiopathic pulmonary fibrosis (IPF) and clinical studies in patients with NASH. The clinical development for PSC is expected to start with a Phase 2a study to be conducted at Virginia Commonwealth University beginning in the fourth quarter of 2023, followed by a Phase 2/3 confirmatory adaptive design trial.

OnKai’s innovative planning tool is anticipated to generate a comprehensive enrollment plan for each trial phase utilizing five new participation models that OnKai designed for integrating underserved communities in clinical studies. OnKai’s Smart-Grid AI Platform will continuously support the trial in the selected local clinics. Local clinics will receive the tools and fair compensation to accompany their patients throughout the process, ensuring individual needs are not disregarded.

The first of the five models to be applied by OnKai is TrialBridge. TrialBridge serves as a conduit, seamlessly linking free and available clinics with their patients to specialist centers, leveraging the role of the community in a patient’s journey. This model enables patients equal access to quality care and, where possible, to clinical trials while maintaining continuity with their local clinic.

This collaboration presents a promising opportunity to foster mutual benefits between Galmed, its principal sites, and the relevant clinics in underserved communities.

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Noam Smetana, OnKai CEO, commented, “I am thrilled about the potential of this innovative partnership to positively impact underserved communities across the US in the coming years. We believe that our project with Galmed, along with others at various stages in our pipeline, will significantly advance health equity within the network of clinics we collaborate with.”

Allen Baharaff, CEO and President of Galmed Pharmaceuticals commented, “We are enthusiastic about employing OnKai’s groundbreaking AI technology in our trial. The application of OnKai’s AI platform is still emerging but potentially disruptive for the conduct of clinical trials. 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 the faster approval and better site performance.”

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