Israel-based biopharma company Galmed Pharmaceuticals entered a strategic partnership with OnKai to employ artificial intelligence (AI) models in enrolling and executing clinical trials in underserved communities.
Galmed will start the partnership with its primary sclerosing cholangitis (PSC) clinical development programme.
The company plans to start with a Phase IIa trial which will be conducted at Virginia Commonwealth University, US, in Q4 2023. This trial will be followed by a Phase II/III confirmatory adaptive design trial.
OnKai’s AI planning tool is anticipated to generate a detailed enrolment plan for each trial phase using five participation models. The first of the five models will be OnKai’s TrialBridge, which connects free and available clinics and their patients to specialist centres. As such, this model enables equal access to quality care and clinical trials while maintaining continuity with their local clinic.
Galmed will also use OnKai’s Smart-Grid AI Platform, which will continuously support the trial in the selected local clinics, which will receive the required tools and fair compensation to accompany their patients through the process, according to Galmed’s announcement.
Clinical Trials Arena has previously reported on the use of AI tools to match patients with appropriate clinical trials.
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Phase II trial design
The single-arm, open-label trial will investigate Galmed’s lead asset Aramchol, a small molecule that acts by targeting stearoyl-coenzyme A desaturase 1 (SCD1) and ABCA1 transporter.
The trial will enrol approximately 15 patients with PSC who will receive 24 weeks of treatment.
The trial’s endpoints will measure the conventional relevant laboratory parameters such as alkaline phosphatase and bilirubin. The outcome measures will also include liver stiffness imaging using MR Elastography (MRE), biliary tract imaging using MR cholangiopancreatography (MRCP) and hepatocyte-specific contrast agents.
The Phase IIa trial will also look at histological fibrosis, molecular assessment and a range of biomarkers of disease activity and fibrosis.
Galmed anticipates that most patients in the trial will also suffer from ulcerative colitis (UC). Alongside the existing rationale and pre-clinical data supporting the use of Aramchol in inflammatory bowel disease (IBD), the company will also assess the status of UC, inflammatory markers and patient-related outcomes (PROs).
AI in clinical trials
In the past few years, AI has been disrupting the conservative nature of the pharmaceutical and clinical trial industries. Recently, Hong-Kong based Insilico Medicine started a Phase II trial with its AI-discovered drug in idiopathic pulmonary fibrosis (IPF).
In April, Netherlands-based myTomorrows launched its beta version of a TrialSearch AI tool to help physicians connect their patients with suitable clinical trials and expanded access programmes (EAP).