The FDA granted a fast track designation to the highly-selective N-terminal domain inhibitor EPI-7386 for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) who are resistant to standard-of-care options, according to an announcement from ESSA Pharma Inc.1

“We are pleased with the FDA’s decision to grant fast track designation for development of EPI-7386 to treat [patients with] mCRPC resistant to standard-of-care treatments,” David R. Parkinson, MD, chief executive officer of ESSA Pharma, stated in a press release. “This designation signifies recognition of the unmet medical need for new and effective treatments for this patient population. EPI-7386 may represent a promising novel treatment option for these patients and the designation offers the opportunity to interact more closely with the FDA during the development [of the agent].”

Previously, the small molecule inhibitor demonstrated preclinical activity in models of antiandrogen-sensitive and -resistant prostate cancer. Now, the safety and tolerability of EPI-7386 in patients with mCRPC who progressed on standard therapies, including second-generation antiandrogens, is under examination in a phase 1 trial (NCT04421222).

As this is a first-in-human trial, the main goal is to examine the safety of the agent and to identify a dose that can be administered to this patient population without any intolerable adverse effects (AEs).2 Other key factors that will be examined include how the amount of the drug in the blood changes over time, the effect of the agent on the disease, the impact of the drug on certain substances in the body, and the possibility of EPI-7386 being able to interact with other agents.

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