Mifepristone

Study Reveals 24% of Difficult-to-Control Type 2 Diabetes Patients Have Hypercortisolism

a month ago

• Corcept Therapeutics' CATALYST trial, the largest study of its kind, found that nearly one-quarter of patients with difficult-to-control type 2 diabetes have hypercortisolism, a condition caused by excessive cortisol activity. • The prevalence phase screened 1,057 patients across 36 U.S. sites using a standardized dexamethasone suppression test, identifying hypercortisolism in patients who maintained high HbA1c levels despite multiple glucose-lowering therapies. • The treatment phase of CATALYST successfully met its primary endpoint of reducing hemoglobin A1c in patients with hypercortisolism using Korlym®, with complete results to be presented at the American Diabetes Association's Scientific Sessions in June 2025.

Afuresertib Plus Paclitaxel Fails to Improve Survival in Platinum-Resistant Ovarian Cancer Trial

2 months ago

• Phase 2 PROFECTA-II/GOG-3044 trial shows afuresertib plus paclitaxel did not significantly improve progression-free or overall survival compared to paclitaxel alone in platinum-resistant ovarian cancer patients. • Biomarker analysis suggests patients with higher pAKT expression (>1) may benefit more from the combination therapy, with median PFS of 5.4 months versus 2.9 months with paclitaxel alone. • The combination therapy demonstrated a manageable safety profile but had higher rates of diarrhea (64.6% vs 19.1%) and more frequent treatment discontinuations (20.2% vs 6.4%) compared to paclitaxel monotherapy.

New Study Shows Ulipristal-Misoprostol Combination Achieves 97% Success Rate for Medical Abortion

4 months ago

• A groundbreaking proof-of-concept study demonstrates that ulipristal acetate, combined with misoprostol, successfully terminated pregnancies in 97% of participants, offering a potential alternative to mifepristone. • The research reveals ulipristal, currently available in pharmacies as emergency contraception, could provide a more accessible and cost-effective option for medication abortion amid ongoing legal challenges to mifepristone. • While the study shows promise, researchers used a 60mg dose of ulipristal, double the amount found in current emergency contraception products, with common side effects including chills, diarrhea, and nausea.

Corcept Therapeutics Submits New Drug Application for Relacorilant to Treat Cushing's Syndrome

5 months ago

• Corcept Therapeutics has submitted a New Drug Application to the FDA for relacorilant, a selective cortisol modulator designed to treat patients with endogenous hypercortisolism (Cushing's syndrome). • The application is supported by positive results from multiple clinical trials, including the pivotal GRACE trial, Phase 3 GRADIENT study, and long-term extension studies, demonstrating improvements in various symptoms with an acceptable safety profile. • Relacorilant showed no instances of serious adverse events common in current treatments, such as drug-induced adrenal insufficiency, hypokalemia, or QT prolongation, positioning it as a potential new standard of care.

Mifepristone Demonstrates Significant HbA1c Reduction in CATALYST Trial for Hypercortisolism and Difficult-to-Control Type 2 Diabetes

5 months ago

• Mifepristone (Korlym) achieved a statistically significant 1.32% placebo-adjusted reduction in HbA1c in patients with hypercortisolism and difficult-to-control type 2 diabetes. • The CATALYST trial revealed that approximately 23.8% of patients with difficult-to-control type 2 diabetes also have hypercortisolism. • The safety profile of mifepristone in the CATALYST trial was consistent with its known safety profile, with no new adverse events identified. • Complete results from the CATALYST trial will be presented at an upcoming medical conference, offering further insights into mifepristone's efficacy and safety.

Dazucorilant Fails Primary Endpoint in Phase 2 ALS Trial but Shows Survival Benefit

5 months ago

• Corcept Therapeutics' dazucorilant did not meet the primary endpoint in the DAZALS Phase 2 trial for amyotrophic lateral sclerosis (ALS). • The study, involving 249 patients, aimed to slow the decline in motor skills as measured by the ALS Functional Rating Scale-Revised (ALSFRS-R). • A statistically significant survival benefit was observed in the 300 mg dazucorilant arm compared to placebo (p-value: 0.02) over the 24-week study. • An open-label extension study is ongoing to assess long-term survival, with results expected in March 2025, and complete DAZALS results will be presented at a future medical conference.

Corcept's Relacorilant Shows Promise in Cushing's Syndrome Treatment

7 months ago

• Corcept Therapeutics' GRADIENT trial demonstrates relacorilant's efficacy in treating Cushing's syndrome, showing clinically meaningful improvements in hypercortisolism signs and symptoms. • The Phase 3 trial supports the New Drug Application (NDA) for relacorilant, expected to be submitted by year-end, offering a potential new treatment option. • Relacorilant was well-tolerated in the GRADIENT study, with a safety profile consistent with previous trials, and no instances of hypokalemia or other severe adverse effects. • Corcept's revenue increased by 48% compared to the same period in 2023, with increased revenue guidance for 2024.

Corcept Completes Enrollment in Phase III Ovarian Cancer Study of Relacorilant

a year ago

• Corcept Therapeutics has completed enrollment in the Phase III ROSELLA study evaluating relacorilant plus Abraxane for recurrent, platinum-resistant ovarian cancer. • The primary endpoint of the ROSELLA study is progression-free survival, with overall survival as a key secondary endpoint; data is expected by late 2024. • Relacorilant is also being evaluated in Phase III trials for Cushing's syndrome and in combination with Keytruda for adrenal cancer, with data readouts expected in 2024.

Drug Development Updates