Benzinga | Mar 18, 2021 08:02AM EDT

ENDRA Life Sciences and Hepion Pharmaceuticals Partner to Drive Efficiencies in NASH Clinical Trials

ENDRA Life Sciences Inc. (NASDAQ:NDRA), a pioneer of Thermo Acoustic Enhanced UltraSound (TAEUS(r)), and Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA), a clinical-stage biopharmaceutical company focused on AI-driven therapeutic drug development for the treatment of NASH and liver disease, announced today the signing of a collaboration agreement to incorporate TAEUS as an add-on technology to support Hepion's patient screening and biomarker measurement during the upcoming Phase 2b study of CRV431.

"We are thrilled to partner with Hepion Pharmaceuticals in the further clinical development of CRV431," said ENDRA's Chairman and Chief Executive Officer Francois Michelon. "It's clear that the pharmaceutical companies and contract research organizations (CRO) driving the NAFLD-NASH therapy pipeline face the same measurement challenges using MRI and liver biopsy as end-user clinicians. By adding ENDRA's cost-effective, non-invasive TAEUS technology to Hepion's protocol, we expect to deliver time and cost savings for the study through simpler, faster and non-invasive measurements of biomarkers such as liver fat. This is a very important first pharmaceutical partnership for ENDRA that we believe opens the door to broader commercial adoption of our technology across the pharma-CRO sector," concluded Michelon.

"Hepion is excited to incorporate ENDRA's technology into screening for our Phase 2b study of CRV431, which targets non-alcoholic steatohepatitis (NASH) and other liver diseases," said Hepion's Chief Executive Officer Dr. Robert Foster. "Although CRV431 does not directly target a metabolic pathway, there is enormous potential value in capturing data on the degree of hepatic steatosis and other biomarkers to refine our understanding of systemic variables associated with NAFLD-NASH. We believe ENDRA's TAEUS system is uniquely designed to accomplish this task for us. Hepion's focus on innovation, in both therapy development and AI applications, leads us naturally to explore new technologies like ENDRA's TAEUS that can lead to efficiencies in execution of our clinical studies," concluded Foster.

In December 2020 Hepion announced positive topline data for the low-dose cohort CRV431 (75 mg) in the Phase 2a AMBITION clinical trial for the treatment of advanced NASH. The AMBITION study is continuing with the higher-dose cohort of CRV431 (225 mg), with patient dosing expected to be completed in the second quarter of 2021. The Phase 2b trial is expected to begin enrolling patients in late 2021.