ESSA Pharma Inc. ("ESSA", or the "Company") (NASDAQ: EPIX), a clinical-stage pharmaceutical company focused on developing novel therapies for the treatment of prostate cancer, today will present preclinical and clinical pharmacology data from ESSA's Phase 1 clinical trial of EPI-7386 for the treatment of patients with metastatic castration-resistant prostate cancer ("mCRPC") at the 2021 American Society of Clinical Oncology Genitourinary ("ASCO GU") Cancers Symposium. EPI-7386, ESSA's lead product candidate, is an investigational, highly-selective, oral, small molecule inhibitor of the androgen receptor's N-terminal domain. ASCO GU is being held virtually from Thursday, February 11 to Saturday, February 13, 2021.
The oral poster presentation titled, "Preclinical and clinical pharmacology of EPI-7386, an androgen receptor N-terminal domain inhibitor for castration-resistant prostate cancer," will be presented and available for viewing starting February 11 at 8:00am ET.
Data highlights compare preclinical projections of EPI-7386's clinical pharmacokinetic parameters to the pharmacokinetic, safety and preliminary clinical data from the initial 200 mg cohort of patients enrolled in ESSA's multi-center, open-label, ascending multiple-dose Phase 1 study of EPI-7386 to treat patients with mCRPC who have become resistant to standard of care treatments. Patients participating in this trial have progressed on two or more approved systemic therapies for mCRPC, including at least one second generation antiandrogen therapy not necessarily in the metastatic disease setting. In this initial cohort of patients receiving the 200 mg once-daily dose, EPI-7386 was well-tolerated with no SAEs observed. The results from this cohort support ESSA's preclinical projections regarding the pharmacologic properties of EPI-7386 in patients. EPI-7386 was well-absorbed, demonstrated high exposure levels and was confirmed to have a long half life of at least 24 hours. The predicted exposures of EPI-7386 in patients were similar to our modeled projections and were still below optimal target exposures of EPI-7386 associated with anti-tumor activity in animal models. Despite the suboptimal 200 mg dose, one out of three patients who completed 12 weeks of therapy experienced a prostate specific antigen ("PSA") decline of more than 50 percent after three cycles of EPI-7386 therapy (12 weeks) with ongoing continued PSA declines continuing through six cycles of therapy, despite previously having failed enzalutamide and abiraterone acetate. ESSA recently completed the 28-Day safety evaluation period for the 400mg dose cohort and is currently dosing patients in the 600 mg cohort.
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