Lumos Pharma, Inc. (LUMO) Enters Collaboration with Massachusetts General Hospital to Evaluate LUM-201

May 5, 2022 9:01 AM EDT

Lumos Pharma, Inc. (NASDAQ: LUMO) today announced a collaboration with Laura Dichtel, MD of Massachusetts General Hospital to evaluate the orally administered growth hormone (GH) secretagogue, LUM-201, in Nonalcoholic Fatty Liver Disease (NAFLD). The investigational new drug (IND) application for this pilot trial has received a study may proceed letter by the FDA.

“I look forward evaluating the use of LUM-201 for patients with NAFLD," said Laura Dichtel, MD, Assistant Professor, Harvard Medical School, Department of Endocrinology, Neuroendocrine Unit. "Prior studies have demonstrated growth hormone’s potential to treat NAFLD, given the hormone’s lipolytic actions in addition to its role as an anti-inflammatory cytokine. Based on these findings, LUM-201, an oral growth hormone secretagogue, could prove to be an efficacious therapeutic for those suffering from this chronic liver disease.”

“Lumos Pharma is honored to partner with Dr. Dichtel and Massachusetts General Hospital to evaluate LUM-201 in NAFLD,” commented Rick Hawkins, CEO and Chairman of Lumos Pharma. “Nonalcoholic fatty liver disease is estimated to be prevalent in approximately 25% of adults worldwide. Hepatic steatosis can progress to nonalcoholic steatohepatitis (NASH) with fibrosis, and NASH-associated liver failure is one of the leading causes of liver transplant in the United States. While we remain focused on our core LUM-201 program in PGHD and identifying the next therapeutic area for LUM-201, we are pleased to support Mass General’s exploration of additional indications for LUM-201.”

This investigator-initiated Phase 2 trial is a single-site, 6-month, open-label pilot study of daily oral LUM-201 in adults with NAFLD. The trial will evaluate a dose of 25 mg/day of LUM-201 in 10 men and women with NAFLD. GH is a critical stimulator of lipolysis, and preclinical data suggest that amplifying GH secretion has the potential to reduce hepatic steatosis and prevent NAFLD progression. Interestingly, enhancing the natural pulsatile release of GH has been shown clinically in short-term studies to be more efficacious in inducing lipolysis than continuous infusions of GH. The primary endpoints will be to determine the changes in both intrahepatic lipid content and hepatic inflammation and fibrosis with growth hormone (GH) augmentation as measured by 1H-MRS and Perspectum’s LiverMultiScan®. Perspectum’s LiverMultiScan® is the leading non-invasive digital tool for liver diagnostics, giving physicians key indications of liver tissue characteristics to empower their diagnostic and patient management decisions. Biopsies will be conducted on a subset of patients to obtain additional information at the genetic and cellular level in this indication.

Lumos Pharma approved an unsolicited grant application for this study and will supply LUM-201 for this pilot trial. Lumos Pharma has a pending application for a method-of-use patent for LUM-201 in NAFLD and retains all intellectual property rights for LUM-201 in this indication.

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