Core Insights - ESSA Pharma Inc. has decided to terminate the Phase 2 clinical trial evaluating masofaniten combined with enzalutamide for patients with metastatic castration-resistant prostate cancer (mCRPC) due to insufficient efficacy signals [1][2] - The interim analysis indicated that the enzalutamide monotherapy performed better than the combination treatment, leading to the conclusion that the primary endpoint of the study is unlikely to be met [1][2] - The company will also terminate other clinical studies involving masofaniten and will withdraw IND and CTAs in various regions, focusing on maximizing shareholder value [1][2] Company Overview - ESSA Pharma Inc. is a clinical-stage pharmaceutical company dedicated to developing novel therapies for prostate cancer [8] - The company retains all rights to masofaniten worldwide, which has received Fast Track designation from the FDA for treating mCRPC resistant to standard treatments [7] Clinical Trial Details - The Phase 2 study was designed as a randomized, open-label trial with a planned enrollment of 120 patients, but only 52 patients were included in the interim analysis [2][6] - The primary endpoint was the proportion of patients achieving a PSA90 response, with secondary endpoints including PSA50 response rates [3][4] Financial Position - As of September 30, 2024, ESSA had cash reserves and short-term investments totaling $126.8 million, with net working capital of $124.3 million [5] - The company has no long-term debt, indicating a strong liquidity position [5]
ESSA Pharma Announces Termination of Phase 2 Study Evaluating Masofaniten Combined with Enzalutamide in Patients with Metastatic Castration-Resistant Prostate Cancer