Hepion Pharma, ENDRA Life Sciences to collaborate in Hepion’s NASH trial

Hepion Pharmaceuticals (NASDAQ:HEPA) and ENDRA Life Sciences (NASDAQ:NDRA) signed a collaboration agreement to incorporate ENDRA’s Thermo Acoustic Enhanced UltraSound (TAEUS) as an add-on technology to support Hepion’s patient screening and biomarker measurement during the upcoming Phase 2b study of CRV431.

“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,” Francois Michelon, chairman and CEO of ENDRA, said in a statement.

“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,” he added.

Dr. Robert Foster, CEO of Hepion, said the company is excited to incorporate ENDRA’s technology into screening for its Phase 2b study of CRV431, which targets non-alcoholic steatohepatitis (NASH) and other liver diseases.

“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 non-alcoholic fatty liver disease-NASH,” he added. “We believe ENDRA’s TAEUS system is uniquely designed to accomplish this task for us.”

In December 2020, Hepion announced positive topline data for the low-dose cohort of 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.