Corcept Therapeutics Initiates Second Phase 2 Trial of Miricorilant to Treat Weight Gain Caused by Antipsychotic Medication

Rhea-AI Summary

Corcept Therapeutics (NASDAQ: CORT) has commenced the GRATITUDE II trial to assess miricorilant in obese patients with schizophrenia suffering from antipsychotic-induced weight gain. The study aims to enroll 150 participants, who will receive either miricorilant or placebo alongside their antipsychotic medication for 26 weeks. This follows the promising results of the Phase 1b trial, which indicated that miricorilant could reduce weight gain and liver enzyme levels in patients. This trial utilizes an enhanced formulation of miricorilant to build on previous findings.

Positive

• Enrollment of first patient in GRATITUDE II trial indicates progress in clinical development.
• GRATITUDE II aims to confirm earlier positive results of miricorilant in weight management.
• The trial's design includes a robust patient cohort of 150 participants, enhancing the credibility of results.

Negative

• None.

MENLO PARK, Calif., Sept. 10, 2020 (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 enrollment of its first patient in GRATITUDE II, a randomized, double-blind, placebo-controlled, Phase 2 trial of miricorilant in obese patients with schizophrenia and long-standing antipsychotic-induced weight gain (APIWG).

GRATITUDE II has a planned enrollment of 150 patients, who will continue to receive their established dose of antipsychotic medication, plus either 600 milligrams of miricorilant, 900 milligrams of miricorilant or placebo, for 26 weeks. The primary endpoint is reduction in bodyweight. GRATITUDE II will be conducted at 35 centers in the United States.

GRATITUDE I, Corcept’s first Phase 2 trial of miricorilant in APIWG, continues to enroll patients with schizophrenia and recent weight gain. Patients in GRATITUDE I receive, in addition to their established antipsychotic regimen, either 600 milligrams of miricorilant or placebo for 12 weeks. The primary endpoint is change in bodyweight.

“Substantial, sustained weight gain and associated metabolic co-morbidities shorten the lives of many of the millions of patients who take antipsychotic medications and significantly reduce quality of life for many more,” said Andreas Grauer, MD, Corcept’s Chief Medical Officer. “Miricorilant has demonstrated promise as a potential treatment for this disorder.¹ In our double-blind, placebo-controlled, Phase 1b trial, after just two weeks of treatment, healthy subjects given miricorilant in addition to olanzapine gained significantly less weight than subjects who received olanzapine plus placebo. Patients receiving miricorilant also experienced smaller increases in the enzymes AST and ALT, which suggests miricorilant may help protect the liver. We hope to confirm and extend our Phase 1b results in GRATITUDE II, which is using an improved formulation of miricorilant and a longer treatment duration.”

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 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 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.

CONTACT:
Christopher S. James, MD
Director, Investor Relations
Corcept Therapeutics
650-684-8725
cjames@corcept.com
www.corcept.com

¹ For data from our studies in animal models of APIWG, see our 2020 American Psychiatry Association (APA) poster at the Research & Pipeline / Publications tab of our website.

FAQ

What is the purpose of the GRATITUDE II trial for CORT?

The GRATITUDE II trial aims to evaluate the efficacy of miricorilant in reducing weight gain in obese patients with schizophrenia who are experiencing antipsychotic-induced weight gain.

What are the key details of the GRATITUDE II trial?

The trial will enroll 150 patients who will receive either 600 mg or 900 mg of miricorilant or a placebo over 26 weeks.

What were the results from the previous Phase 1b trial for miricorilant?

In the Phase 1b trial, subjects receiving miricorilant with olanzapine gained significantly less weight compared to those on olanzapine plus placebo.

How might the GRATITUDE II trial impact Corcept Therapeutics' stock?

Positive results from the GRATITUDE II trial could enhance investor confidence and promote stock price appreciation for CORT.

When was the first patient enrolled in the GRATITUDE II trial?

The first patient in the GRATITUDE II trial was enrolled on September 10, 2020.