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ESSA Pharma Announces Clinical Collaboration Agreement with Bayer to Evaluate the Combination of EPI-7386 and Darolutamide

Thursday, April 29, 2021

ESSA Pharma Inc., a clinical-stage pharmaceutical company focused on developing novel therapies for the treatment of prostate cancer, today announced that the Company has entered into a clinical trial collaboration and supply agreement with Bayer to evaluate ESSA's lead product candidate, EPI-7386, a first-in-class N-terminal domain androgen receptor inhibitor, in combination with Bayer's androgen receptor inhibitor, darolutamide, in patients with metastatic castration-resistant prostate cancer ("mCRPC").

Under the terms of the agreement, Bayer may sponsor and conduct a Phase 1/2 study to evaluate the safety, pharmacokinetics and efficacy of the combination of EPI-7386 and darolutamide in mCRPC patients. ESSA will supply EPI-7386 for the trial and will retain all rights to EPI-7386. The clinical study is expected to start in 2021.

"We are delighted to collaborate with Bayer to explore the potential clinical role of EPI-7386 in combination with Bayer's darolutamide in patients with metastatic castration-resistant prostate cancer, who have progressed on androgen deprivation therapy," said Dr. David R. Parkinson, Chief Executive Officer, ESSA Pharma Inc. "Combining our two therapies will simultaneously target both ends of the androgen receptor, and potentially allow for a more potent approach to suppressing androgen activity. We look forward to investigating the combination of these therapies and their potential role together in the treatment of prostate cancer."

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