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ESSA Pharma Inc (NASDAQ: EPIX) has announced initial data from Phase 1 trial evaluating the company's lead candidate, EPI-7386, to treat patients with metastatic castration-resistant prostate cancer. Data were at the 2021 American Society of Clinical Oncology Genitourinary
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 in patients who progressed on two or more approved systemic therapies.
In this initial cohort, EPI-7386 was well-tolerated with no severe adverse events observed.
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 modeled projections and were still below optimal target exposures of EPI-7386 associated with anti-tumor activity in animal models.
One out of three patients who completed 12 weeks of therapy experienced a prostate-specific antigen decline (PSA) of more than 50% 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.
More clinical data is expected in the second half of 2021.
Price Action: EPIX stock gained 46% at $28.29 during market trading hours on the last check Thursday.
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