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

·6 min read

Hepion to include ENDRA's TAEUS technology in Phase 2b trial of CRV431

ANN ARBOR, MI and EDISON, NJ / ACCESSWIRE / March 18, 2021 / ENDRA Life Sciences Inc. (NASDAQ:NDRA), a pioneer of Thermo Acoustic Enhanced UltraSound (TAEUS®), 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.

About ENDRA Life Sciences Inc.

ENDRA Life Sciences is the pioneer of Thermo Acoustic Enhanced UltraSound (TAEUS™), a ground-breaking technology being developed to visualize tissue like MRI, but at 1/50th the cost and at the point of patient care. TAEUS is designed to work in concert with the over one million ultrasound systems in use globally today. TAEUS is initially focused on the measurement of fat in the liver as a means to assess and monitor Non-Alcoholic Fatty Liver Disease (NAFLD) and inflammation (NASH), chronic liver conditions that affect over one billion people globally, and for which there are no practical diagnostic tools. Beyond the liver, ENDRA is exploring several other clinical applications of TAEUS, including visualization of tissue temperature during energy-based surgical procedures. For more information, please visitwww.endrainc.com.

About Hepion Pharmaceuticals Inc.

Hepion Pharmaceuticals is a clinical-stage biopharmaceutical company focused on the development of targeted therapies for the treatment of non-alcoholic steatohepatitis (NASH) and other liver diseases.

Hepion's lead drug candidate, CRV431, is a potent inhibitor of cyclophilins, which are involved in many disease processes. CRV431 is currently in clinical-phase development for the treatment of NASH, with the potential to play an important role in the overall treatment of liver disease - from triggering events through to end-stage disease. CRV431 has been shown to reduce liver fibrosis and hepatocellular carcinoma tumor burden in experimental models of NASH; and has demonstrated antiviral activities towards HBV, HCV, and HDV through several mechanisms, in preclinical studies.

Hepion has created a proprietary AI platform, called AI-POWR™, which stands for Artificial Intelligence - Precision Medicine; Omics (including genomics, proteomics, metabolomics, transcriptomics, and lipidomics); World database access; and Response and clinical outcomes. Hepion intends to use AI-POWR™ to help identify which NASH patients will best respond to CRV431, potentially shortening development timelines and increasing the delta between placebo and treatment groups. In addition to using AI-POWR™ to drive its ongoing Phase 2a NASH program, Hepion will use the platform to identify additional potential indications for CRV431 to expand the company's footprint in the cyclophilin inhibition therapeutic space.

Forward-Looking Statements

All statements in this news release that are not based on historical fact are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements, which are based on certain assumptions and describe our future plans, strategies and expectations, can generally be identified by the use of forward-looking terms such as "believe," "expect," "may," "will," "should," "could," "seek," "intend," "plan," "goal," "estimate," "anticipate" or other comparable terms. Examples of forward-looking statements for ENDRA include, among others, estimates of the timing of future events and achievements, such as the expectations regarding commercializing the TAEUS device, establishing evaluation reference sites and initial sales in Europe, receipt of U.S. Food and Drug Administration ("FDA") regulatory approval, and expectations concerning ENDRA's business strategy, which may be affected by risks related to the impact of COVID-19 on its business plan, its ability to find and maintain development partners, market acceptance of its technology and the amount and nature of competition in its industry, its ability to protect its intellectual property, and other risks and uncertainties described in its filings with the Securities and Exchange Commission. Examples of forward-looking statements for Hepion include, among others, substantial competition; our need for additional financing; uncertainties of patent protection and litigation; risks associated with delays, increased costs and funding shortages caused by the COVID-19 pandemic; uncertainties with respect to lengthy and expensive clinical trials, that results of earlier studies and trials may not be predictive of future trial results; uncertainties of government or third party payer reimbursement; limited sales and marketing efforts and dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. The forward-looking statements made in this news release speak only as of the date of issuance, and ENDRA and Hepion assume no obligation to update any such forward-looking statements to reflect actual results or changes in expectations, except as otherwise required by law.

ENDRA Company Contact:

David Wells
Chief Financial Officer
(734) 997-0464

ENDRA Investor Relations Contact:

Yvonne K. Briggs
LHA Investor Relations
(310) 691-7100

Hepion Pharmaceuticals Investor Relations Contact:

Stephen Kilmer
(646) 274-3580

SOURCE: ENDRA Life Sciences Inc.

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