ESSA Pharma Inc. (NASDAQ: EPIX), a Canada-based clinical-stage pharmaceutical company, announced on Wednesday that it has dosed the first patient in the company-sponsored Phase 1/2 study to assess the safety, tolerability and preliminary efficiency of EPI-7386, a first-in-class N-terminal domain androgen receptor inhibitor, in combination with Astellas Pharma Inc.'s and Pfizer Inc.'s ligand-binding domain androgen receptor inhibitor, enzalutamide, to treat patients with metastatic castration-resistant prostate cancer (mCRPC).
The Phase 1/2 clinical trial (NCT05075577) starts with an initial phase one part wherein the doses of each drug are adjusted subsequent to a phase two part wherein the single agent enzalutamide is compared to the combination of enzalutamide and EPI-7386. The phase 1 study is likely to enrol up to 30 mCRPC patients who have not yet been treated with second-generation antiandrogen therapies.
The aim of the phase 1 portion of the study is to assess the safety and tolerability of the drug combination and establish the recommended phase two doses for EPI-7386 and enzalutamide when dosed in combination. The phase two study is likely to enrol 120 mCRPC patients who have not yet been treated with second-generation antiandrogen therapies. The aim of the phase two part of the study is to assess the safety, tolerability and antitumor activity of EPI-7386 in combination with a fixed dose of enzalutamide compared with enzalutamide as a single agent.
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