SBIR grant awarded to develop treatment for alcoholic liver disease-associated hepatorenal syndrome

The Institute of Human Virology (IHV) at the University of Maryland School of Medicine (UMSOM) and MitoPower LLC ("MitoPower") were awarded an SBIR (Small Business Innovation Research) grant of up to $6.5 million over five years from the National Institutes of Health's National Institute on Alcohol Abuse and Alcoholism. The funds will support the development of MitoPower's lead compound, MP-04, for the treatment of kidney dysfunction due to alcoholic liver disease, a condition known as alcoholic liver disease-associated hepatorenal syndrome (HRS). The IHV, a Center of Excellence of the Global Virus Network (GVN), will conduct first-in-human single and multiple ascending dose studies to test the safety of the compound, followed by a Phase 1b study in patients.

There are no current therapeutic options that specifically address the cellular dysfunction and systemic inflammatory response that contribute to the severe impairment of liver and kidney function and progressive organ failure in patients with severe alcoholic hepatitis. We are working to complete IND-enabling studies for MP-04 and are excited to collaborate with IHV to characterize this promising compound in human studies."

Mani Subramanian, MD, PhD and CEO of MitoPower

More than 250,000 hospitalizations each year in the U.S. are due to complications of alcoholic liver disease. HRS is an acute complication of cirrhosis (liver scarring) or a severe alcoholic hepatitis (liver inflammation) progressive condition leading to kidney failure. HRS is associated with mortality rates reaching 50%, with many patients requiring invasive treatments such as dialysis and/or liver transplant.

"There is an urgent, unmet need for an effective therapy to treat HRS caused by severe alcoholic hepatitis and cirrhosis. Globally, the incidence and prevalence of alcoholic liver disease continues to increase and remains a significant cause of liver failure and liver transplantation," said Prof. Shyam Kottilil, MBBS, PhD, Professor of Medicine and Director of the Division of Clinical Care and Research, Institute of Human Virology at the University of Maryland School of Medicine, and senior advisor to the Global Virus Network (GVN). "MP-04 is a novel therapeutic that has shown promise in preclinical studies to reverse organ dysfunction and systemic inflammatory response syndrome (SIRS) that holds promise in potentially reversing HRS."

The Theodore E. Woodward Chair in Medicine Stephen N. Davis, MBBS, FRCP, FACE, MACP, said, "We are honored to partner academic research with industry to develop therapies that improve our patients' health and quality of life, especially for chronic diseases for which we have no known treatments."

UMSOM Dean E. Albert Reece, MD, PhD, MBA, Executive Vice President for Medical Affairs, UM Baltimore, and the John Z. and Akiko K. Bowers Distinguished Professor, said, "HRS affects many Native American and Alaskan Natives disproportionately, and Black and Mexican Americans are more likely to suffer worse outcomes. Developing an effective treatment will be the first step in finding a way to address these disparities."

Robert Gallo, MD, the Homer & Martha Gudelsky Distinguished Professor in Medicine, Co-Founder & Director of the Institute of Human Virology at UMSOM, and Co-Founder and International Scientific Director of the Global Virus Network (GVN), said, "The Institute is pleased to see our Clinical Trials Unit's portfolio continue to grow under the terrific leadership of Professor Kottilil. While we continue to focus on therapeutics for viruses such as HIV and SARS-CoV-2, it is also important that we research innovations that can combat devastating chronic illnesses, such as liver disease and kidney dysfunction."

This award was granted by the National Institutes of Health under Award Number U44 AA029833. The content of this press release is solely the responsibility of the author and does not necessarily represent the official views of the NIH.