Benzinga | Jul 15, 2020 07:05AM EDT

ESSA Pharma Announces First Patient Dosed In A Phase 1 Clinical Trial Of EPI-7386 For Metastatic Castration-Resistant Prostrate Cancer

HOUSTON and VANCOUVER, BC, July 15, 2020 /PRNewswire/ - ESSA Pharma Inc. (NASDAQ:EPIX) (TSXV:EPI), a clinical-stage pharmaceutical company focused on developing novel therapies for the treatment of prostate cancer, today announced the first patient dosed in a Phase 1 clinical trial designed to demonstrate the safety and tolerability of EPI-7386 in metastatic castration-resistant prostate cancer ("mCRPC") patients who failed standard of care treatments, including second generation anti-androgens. EPI-7386 is a small molecule inhibitor of the N-terminal domain of the androgen receptor (AR) which has shown preclinical activity in both anti-androgen sensitive and anti-androgen resistant prostate cancer models.

"The initiation of this study represents a significant milestone for ESSA as it brings us a step closer to offering a potentially meaningful new therapeutic option to prostate cancer patients," said Dr. David Parkinson MD, Chief Executive Officer of ESSA. "The fact that EPI-7386 was first synthesized less than two years ago and yesterday began dosing in patients is a testament to the efficiency of our team and our collaborators". Dr. Parkinson continued, "The results from this trial will guide our future development plans and confirm the potential contribution of N-terminal domain AR inhibition to the treatment of prostate cancer".

The Phase 1 clinical trial (NCT04421222) expects to enroll approximately 18 mCRPC patients in the dose escalation part of the study at selected clinical sites in the United States and Canada, with an additional ten patients planned to be enrolled in a dose expansion cohort involving additional clinical sites. The study will evaluate the safety and tolerability of EPI-7386 while additionally characterizing the pharmacokinetic, biological and anti-tumor effects of therapy.