ESSA Pharma Initiates Phase 2 Study for Masofaniten in Combination with Enzalutamide for Metastatic Prostate Cancer Treatment

ESSA Pharma Inc, a clinical-stage pharmaceutical company focused on developing innovative therapies for prostate cancer, has announced the initiation of the Phase 2 portion of its Phase 1/2 study. The study aims to evaluate the efficacy of masofaniten (formerly known as EPI-7386), a first-in-class N-terminal domain androgen receptor inhibitor, in combination with enzalutamide, an antiandrogen developed by Astellas and Pfizer. The Phase 2 study will enroll approximately 120 patients with metastatic castration-resistant prostate cancer (mCRPC) who have not received second-generation antiandrogens.

The Phase 1 dose escalation portion of the study has already shown promising results, leading to the selection of updated data from the first four patient cohorts for a poster presentation at the upcoming European Society of Medical Oncology (ESMO) Congress in Madrid, Spain. The Phase 2 dose expansion portion of the study will be a randomized, open-label trial, comparing the combination of masofaniten (600mg twice-daily) and enzalutamide (160mg once daily) to enzalutamide alone.

Dr. David Parkinson, President and CEO of ESSA, expressed excitement about the initiation of the Phase 2 study and the potential of the combination therapy to improve long-term clinical outcomes for patients with mCRPC. The favorable safety profile observed in the Phase 1 portion of the study has allowed for the recommended Phase 2 dose regimen of masofaniten 600mg BID combined with enzalutamide 160mg QD.

Masofaniten is a highly selective, oral, small molecule inhibitor that targets the N-terminal domain of the androgen receptor, a key pathway in prostate cancer growth. The unique mechanism of action of masofaniten, which selectively binds to the N-terminal domain, sets it apart from other therapies currently available. The U.S. Food and Drug Administration has granted Fast Track designation to masofaniten for the treatment of adult male patients with mCRPC resistant to standard-of-care treatment.

ESSA is committed to advancing the development of masofaniten and is also conducting a Phase 1 monotherapy study in patients with mCRPC whose tumors have progressed on standard-of-care therapies. The company retains all rights to masofaniten worldwide.

For more information about ESSA Pharma and its ongoing clinical trials, please visit their website at www.essapharma.com. Stay updated by following them on Twitter and LinkedIn.