FDA grants fast track designation for oral mCRPC agent

September 16, 2020

The FDA has granted fast track designation to EPI-7386, an oral, highly selective N-terminal domain inhibitor of the androgen receptor for treatment of mCRPC resistant to standard-of-care treatment.

The FDA has granted fast track designation to EPI-7386, an oral, highly selective N-terminal domain inhibitor of the androgen receptor (AR), for treatment of metastatic castration-resistant prostate cancer (mCRPC) resistant to standard-of-care treatment, ESSA Pharma Inc announced.1

ESSA Pharma is conducting a phase 1 trial (NCT04421222)2 trial of EPI-7386 that will evaluate the safety and tolerability of the agent and also examine its pharmacokinetic, biological, and anti-tumor effects.

"We are pleased with the FDA's decision to grant Fast Track designation for development of EPI-7386 to treat mCRPC patients resistant to standard-of-care treatments. 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 EPI-7386,” David R. Parkinson, MD, Chief Executive Officer of ESSA Pharma, said in a press release.1

Speaking with Urology Times®, J. Brantley Thrasher, MD, explained that EPI-7386 is part of a new class of AR-targeting compounds known as anitens.

“These compounds differ from currently available AR-blocking compounds because they bind to the N-terminal domain of the AR instead of the ligand binding domain. Due to its novel binding and mechanism of blocking the AR, it appears to work well in those patients who are progressing on current standard of care treatments,” said Thrasher, executive director of the American Board of Urology in Charlottesville, Virginia.

Added Thrasher, “I think this therapy will provide another agent in the armamentarium for mCRPC and will likely be used at first for those recalcitrant to standard therapies like enzalutamide [Xtandi] or abiraterone [Zytiga] but will quickly be tested to find out whether it works best in combination with one of these agents and what the best sequence of delivery will be.”

References

1. ESSA Pharma announces fast track designation granted by the FDA to EPI-7386 for the treatment of metastatic castration-resistant prostate cancer. Press release. Essa Pharma. September 14, 2020. Accessed Sept. 16, 2020. https://bit.ly/3iCGsyL

2. Oral EPI-7386 in patients With metastatic castration-resistant prostate cancer (EPI-7386). Updated September 16, 2020. Accessed September 16, 2020. ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ https://clinicaltrials.gov/ct2/show/NCT04421222