MENLO PARK, CA, USA I May 06, 2021 I 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 First, the elevations in ALT and AST resolved after miricorilant was withdrawn.”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)
“Second, the patients with elevated liver enzymes exhibited large reductions in liver fat rapidly.” (See Table 1)
| Patient | Miricorilant (per day) |
Days on Drug |
% Liver Fat at Baseline |
% Liver Fat at Follow up |
Days Between Last Dose and Follow-up |
Relative Reduction in % Liver Fat |
|
| Patient 1 | 900 mg | 30 | 17.6 | 6.1 | 19 | -65.3 | % |
| Patient 2 | 900 mg | 31 | 27.8 | 17.1 | 64 | -38.5 | % |
| Patient 3 | 900 mg | 44 | 28.3 | 15.0 | 16 | -47.0 | % |
| Patient 4 | 600 mg | 34 | 12.6 | 3.3 | 21 | -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 miricorilant can produce such significant reductions in liver fat safely and that the reduction results in a meaningful improvement in NASH.”
About the Phase 2 Trial
This double-blind, placebo-controlled Phase 2 study is designed to enroll 120 patients with presumed NASH at 15 clinical sites in the United States. Patients are randomized 1:1:1 to receive a daily dose of 600 mg of miricorilant, 900 mg of miricorilant or placebo. The trial’s primary endpoint is reduction in liver fat at week 12 as assessed by MRI-PDFF, with a secondary endpoint being the proportion of patients who exhibit liver fat reduction of at least 30 percent at week 12. Additional information about the study (NCT03823703) is at www.ClinicalTrials.gov.
About Corcept Therapeutics
Corcept is 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 the stress hormone cortisol. Korlym® was the first drug approved by the U.S. Food and Drug Administration for patients with Cushing’s syndrome. Corcept has discovered a large portfolio of proprietary compounds, including miricorilant, that selectively modulate the effects of cortisol. The company owns extensive United States and foreign intellectual property covering the composition of its selective cortisol modulators and the use of cortisol modulators to treat a variety of serious disorders.
SOURCE: Corcept Therapeutics
