ESSA Pharma tank as it drops Phase II masofaniten study
US clinical-stage firm ESSA Pharma (Nasdaq: EPIX) has made the decision to terminate the Phase II clinical trial evaluating in a 2:1 randomization masofaniten combined with enzalutamide versus enzalutamide single agent in patients with metastatic castration-resistant prostate cancer (mCRPC) naïve to second-generation antiandrogens.
Masofaniten is ESSA’s sole clinical-stage candidate, and the news caused the company’s shares to plummet 73% to $1.40 by close of trading on Friday.
The company explained that this decision, mutually agreed upon by both senior management and the board of directors, was based on a protocol-specified interim review of the safety, PK and efficacy data, which showed a much higher rate of PSA90 response in patients treated with Astellas (TYO: 4503) and Pfizer’s (NYSE: PFE) Xtandi (enzalutamide) monotherapy (which is standard of care for this patient population) than were expected based upon historical data.
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