Hepion Pharmaceuticals Appoints Accomplished Life Sciences Industry Veteran, Dr. Launa J. Aspeslet, as Chief Operating Officer

Rhea-AI Summary

Hepion Pharmaceuticals (NASDAQ:HEPA) appointed Dr. Launa J. Aspeslet as Chief Operating Officer to bolster the clinical program for its lead candidate, rencofilstat. Dr. Aspeslet brings over 25 years of experience from her previous role as CEO of Translational Research in Oncology and significant contributions at Isotechnika Pharma. She joins Hepion after the company reported positive Phase 2a results and is preparing for three additional Phase 2 studies targeting non-alcoholic steatohepatitis (NASH) and hepatocellular carcinoma (HCC). This leadership change aims to enhance strategic development.

Positive

• Appointment of Dr. Launa J. Aspeslet as COO enhances leadership and operational capacity.
• Dr. Aspeslet has a proven track record in drug development, particularly in oncology.
• Positive Phase 2a data for rencofilstat supports ongoing development efforts.

Negative

• Transition in leadership may introduce temporary operational disruptions.
• Continued risks in clinical trials and regulatory approvals remain.

- Dr. Aspeslet joins the Company to support rencofilstat’s clinical program -

EDISON, N.J., June 14, 2022 (GLOBE NEWSWIRE) -- Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA), a clinical stage biopharmaceutical company focused on Artificial Intelligence (“AI”)-driven therapeutic drug development for the treatment of non-alcoholic steatohepatitis (“NASH”) and hepatocellular carcinoma (“HCC”), today announced the appointment of Launa J. Aspeslet, PhD, RAC, as Chief Operating Officer.

A versatile C-level executive with more than 25 years of progressive life sciences industry leadership and management experience, Dr. Aspeslet has expertise in strategic planning and growth; clinical research; regulatory affairs; quality assurance and control; and research and development. She was most recently the CEO of Translational Research in Oncology (TRIO), a clinical research organization that manages oncology trials around the globe. Dr. Aspeslet was previously a biotechnology consultant where she planned, implemented, and executed drug, device, or combination product development strategies for early-stage companies. For 17 years, she held positions of increasing responsibility and leadership at Isotechnika Pharma Inc., serving as its Chief Operating Officer until its acquisition of Aurinia Pharmaceuticals Inc. in 2013. Dr. Aspeslet received a Bachelor of Science degree in chemistry from the University of Lethbridge and a Doctor of Philosophy degree in Pharmaceutical Sciences from the University of Alberta. She has Regulatory Affairs Certification (RAC) and completed the Ivey Business School at Western University’s executive program.

“At Isotechnika, Launa was an integral part of the team that discovered and developed voclosporin, which in January 2021 received U.S. Food and Drug Administration approval for the treatment of lupus nephritis,” said Robert Foster, PharmD, PhD, Hepion’s CEO. “I am thrilled to once again be working with Launa, this time on the development of Hepion’s lead candidate, rencofilstat, and on behalf of our team would like to extend her the warmest welcome.”

Dr. Aspeslet commented, “In addition to being excited by this opportunity to work with my talented colleagues on a second development program, I am energized to join the Company on the heels of positive Phase 2a data and ahead of three additional Phase 2 studies of rencofilstat for the treatment of NASH and HCC.”

About Hepion Pharmaceuticals

The Company's lead drug candidate, rencofilstat, is a potent inhibitor of cyclophilins, which are involved in many disease processes. Rencofilstat 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. Rencofilstat 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 nonclinical studies. In November 2021, the U.S. Food and Drug Administration (“FDA”) granted Fast Track designation for rencofilstat for the treatment of NASH. That was soon followed in December 2021 by the FDA’s acceptance of Hepion’s investigational new drug (IND) application for rencofilstat for the treatment of hepatocellular carcinoma (HCC).

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 rencofilstat, potentially shortening development timelines and increasing the delta between placebo and treatment groups. In addition to using AI-POWR™ to drive its ongoing NASH clinical development program, Hepion intends to use the platform to identify additional potential indications for rencofilstat to expand the company's footprint in the cyclophilin inhibition therapeutic space.

Forward-Looking Statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimated,” and “intend,” among others. These forward-looking statements are based on Hepion Pharmaceuticals’ current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, substantial competition; our ability to continue as a going concern; 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. As with any drug candidates under development, there are significant risks in the development, regulatory approval, and commercialization of new products. There are no guarantees that future clinical trials discussed in this press release will be completed or successful, or that any product will receive regulatory approval for any indication or prove to be commercially successful. Hepion Pharmaceuticals does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in Hepion Pharmaceuticals’ Form 10-K for the year ended December 31, 2021, and other periodic reports filed with the Securities and Exchange Commission.

For further information, please contact:

Stephen Kilmer
Hepion Pharmaceuticals Investor Relations
Direct: (646) 274-3580
skilmer@hepionpharma.com

FAQ

What is the significance of Dr. Aspeslet's appointment at Hepion Pharmaceuticals?

Dr. Aspeslet's appointment as COO is aimed at strengthening the clinical program for rencofilstat, leveraging her extensive experience in drug development and operational leadership.

What are the future plans for rencofilstat following the positive Phase 2a results?

Following the promising Phase 2a results, Hepion is preparing for three additional Phase 2 studies focused on treating NASH and HCC.

How might Dr. Aspeslet's background influence Hepion's development strategy?

With over 25 years in the life sciences sector, Dr. Aspeslet's experience is expected to enhance Hepion's strategic planning and execution in its clinical programs.

What challenges does Hepion face in its clinical trials?

Hepion faces challenges such as the uncertainty of trial outcomes, regulatory approvals, and the inherent risks of drug development.