2022-05-05 09:09:00 LUMO Lumos Pharma
05/05/22 05/0509:09 05/05/2209:09 | Lumos Pharma, MGH enter clinical collaboration for oral LUM-201Lumos Pharma announced a collaboration with Laura Dichtel, MD of Massachusetts General Hospital to evaluate the orally administered growth hormone secretagogue, LUM-201, in Nonalcoholic Fatty Liver Disease. The investigational new drug application for this pilot trial has received a study may proceed letter by the FDA. 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 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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