ESSA Pharma Inc. (NASDAQ: EPIX) stock gained by 9.68% at last close while the EPIX stock price rises by 5.73% during the pre-market trading session. ESSA is a clinical-stage pharmaceutical company specializing in the development of new and patented drugs for the care of prostate cancer patients.
ESSA Pharma revealed on May 10, 2021, that they are undertaking a Phase 1 clinical trial of EPI-7386 in patients with metastatic castration-resistant prostate cancer (mCRPC) who have advanced on two or more systemic treatments, plus at least one second-generation anti-androgen therapy (NCT04421222). It’s a multi-center, open-label, ascending multiple-dose experiment with the main goal of determining EPI-7386’s protection and tolerability. Secondary goals involve deciding EPI-7386’s overall acceptable dosage, identifying the suggested Phase 2 dose, testing EPI-7386’s pharmacokinetics (PK), and examining any possible drug-drug interactions. Once regular dosage cohorts of 200, 400, 600, 800, and 1000 mg are planned. The 800 mg cohort is currently being dosed by ESSA Pharma.
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In conclusion, the preliminary clinical data for EPI-7386 provided by ESSA is quite promising, as the PK parameters for the 200 mg dosing cohort matched very well with those expected by preclinical studies, the half-life of nearly 24 hours is compatible with once-daily dosing, EPI-7386 was generally well-tolerated, and a serum PSA drop of >50% was found in a patient who had failed to respond to other treatments.
EPIX anticipates hearing more about the Phase 1 trial of EPI-7386 in the fourth quarter of 2021. The trial’s preliminary findings are promising, and they anticipate seeing more favorable responses in patients in the higher dose cohorts. EPIX is pleased to see the partnerships that have been put in place to enable such trials to take place, as this has always been part of EPIX’s approach. The estimate of ESSA remains at $40 per share, with no revisions to their model, and they continue to consider it a top choice in their small-cap biotech coverage universe.