On March 31, 2020 ESSA Pharma Inc. ("ESSA", or the "Company") (NASDAQ: EPIX, TSX-V: EPI), a pharmaceutical company focused on developing novel therapies for the treatment of prostate cancer, reported that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) to evaluate its lead clinical candidate, EPI-7386, in a Phase 1 clinical study for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) (Press release, ESSA, MAR 31, 2020, View Source [SID1234556057]).
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"We believe that EPI-7386 has the potential to be an important new therapy for men with prostate cancer. All of the preclinical data accumulated to date leads us to believe that it will be an active agent with a good PK profile," commented David R. Parkinson, MD, CEO of ESSA. "We remain focused on conducting a clinical trial of this unique inhibitor of the N-terminal domain of the androgen receptor in adult male patients with mCRPC resistant to standard of care treatments. We are pleased that we were able to file the IND as planned. This is a significant milestone for the Company and we look forward to beginning clinical testing of EPI-7386 in patients as soon as possible."
The Company also provided a business update as the COVID-19 situation rapidly evolves. To date, the global coronavirus outbreak has not had a material impact on the Company’s business operations. At present, ESSA does not anticipate changes to planned achievement of key clinical milestones in calendar year 2020, but is continuing to monitor the situation.
Business Updates:
We remain on track to commence the monotherapy clinical study of EPI-7386 in mCRPC patients resistant to standard of care treatments in Q2 2020.
Enrollment will be approximately 18 patients at multiple US and Canadian medical institutions in a standard 3+3 trial design with up to 10 additional patients enrolled in the dose expansion cohort.
Clinical sites are being finalized and we are preparing for clinical trial initiation. We are working with our contract research organization ("CRO") to prepare for clinical trial initiation, despite the current limitations on travel. We will also augment our trial risk management plan including mitigation strategies to deal with clinical trial sites that may be impacted by the COVID-19 situation. This plan will incorporate the latest FDA guidance regarding clinical trial conduct during the COVID-19 pandemic.
Although our in-person lab activities are affected by COVID-19, we have conducted extensive gene expression studies demonstrating differentiation of our N-terminal domain (NTD) inhibition mechanism from ligand binding domain (LBD) inhibition by anti-androgens as well as the unique quantitative and qualitative effects of the combination of NTD and LBD androgen receptor inhibition. The full analysis of these results will be presented at a future scientific meeting.
The Company ended December 31, 2019 with $45.9 million cash, which we believe provides operating funds through fiscal year end 2022 (September 30) and will allow ESSA to complete the Phase 1 monotherapy dose-escalation study, an expansion phase to that study, and a combination study of EPI-7386 with currently utilized antiandrogens in metastatic prostate cancer patients with earlier stages of the disease.