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Corcept Therapeutics Observes Large Reductions of Liver Fat and Transient Liver Enzyme Elevations in Phase 2 Trial of Miricorilant as a Potential Treatment for Patients with Nonalcoholic Steatohepatitis (NASH)
MENLO PARK, Calif., May 06, 2021 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and
About this update from Corcept Therapeutics Incorporated
[{"type":"text","content":"MENLO PARK, Calif., May 06, 2021 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of cortisol, today announced interim findings from the Phase 2 trial of its selective cortisol modulator miricorilant in patients with presumed NASH. “This was our first trial to evaluate miricorilant as a treatment for patients with liver disease. When we observed elevated ALT and AST levels in four of the first five patients who received miricorilant for four weeks, we suspended the study,” said Andreas Grauer, MD, Corcept’s Chief Medical Officer. “Our investigation has made two notable findings. First, the elevations in ALT and AST resolved after miricorilant was withdrawn.” (See Figures 1 and 2) A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/00d4659c-26e2-4ecf-aa44-10cefb13a5d3 “Second, the patients with elevated liver enzymes exhibited large reductions in liver fat rapidly.” (See Table 1) PatientMiricorilant (per day)Days on Drug% Liver Fat at Baseline% Liver Fat at Follow upDays Between Last Dose and Follow-up RelativeReduction in % Liver Fat Patient 1900 mg3017.66.119-65.3%Patient 2900 mg3127.817.164-38.5%Patient 3900 mg4428.315.016-47.0%Patient 4600 mg3412.63.321-73.8%Table 1: Reduction in liver fat content measured by magnetic resonance imaging-proton density fat fraction (MRI-PDFF) “We had planned to enroll 120 patients in this study, which we thought would be sufficient to detect a 30 percent reduction in liver fat after 12 weeks,” continued Dr. Grauer. “These patients exhibited much larger reductions after receiving miricorilant for 4-6 weeks. These findings are particularly striking because their follow-up liver MRI was some distance from their final dose.” “Liver fat reductions achieved this quickly and of this magnitude are rarely seen ,” said Dr. Stephen A. Harrison, M.D., Medical Director for Pinnacle Clinical Research, San Antonio, Texas, Visiting Professor of Hepatology, Oxford University and principal investigator in Corcept’s Phase 2 trial. “Fatty liver disease and NASH afflict many millions of people and there are no approved treatments. Further study is warranted to evaluate if miric...