Thursday, ESSA Pharma Inc EPIX shares closed 22.6% lower at $6.80. According to data from Benzinga Pro, session volume stands at 447.615K compared to the average volume (100 days) of 132.003K.
The company announced the presentation of updated dose escalation data from its Phase 1/2 study evaluating masofaniten (formerly EPI-7386) in combination with enzalutamide at the 2024 ASCO Genitourinary Cancers Symposium.
Masofaniten is a first-in-class N-terminal domain androgen receptor inhibitor that suppresses androgen activity through a novel mechanism of action and is being developed for prostate cancer.
In the patients evaluable for efficacy (n=16), rapid, deep, and durable reductions in prostate-specific antigen (PSA) were observed, regardless of previous chemotherapy status, including in patients who received lower than the full dose of enzalutamide (120 mg).
Across all dose cohorts, 88% of patients (14 of 16) achieved PSA50, 81% of patients (13 of 16) achieved PSA90, 69% of patients (11 of 16) achieved PSA90 in less than 90 days, and 63% of patients (10 of 16) achieved PSA <0.2ng/mL.
While the data for disease PSA progression are still maturing with a current median follow-up of 11.1 months, the median time to PSA progression is 16.6 months.
The randomized, open-label, two-arm, Phase 2 dose expansion portion of the study is underway to evaluate the combination of masofaniten and enzalutamide versus single-agent enzalutamide in patients with metastatic castration-resistant prostate cancer (mCRPC) naïve to second-generation anti-androgens.
At September 30, 2023, ESSA Pharma had available cash reserves and short-term investments of $148.1 million. The company’s cash position is expected to be sufficient to fund current and planned operations through 2025.
Price Action: EPIX stock is down 1.03% at $6.73 premarket Friday.
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