Essa Pharma presents Phase 1 clinical data of masofaniten in prostate cancer

ESSA Pharma announced the presentation of updated dose escalation data from its Phase 1/2 study evaluating masofaniten in combination with enzalutamide at the 30th Annual Prostate Cancer Foundation Scientific Retreat. 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 the treatment of prostate cancer. Masofaniten combined with enzalutamide, continues to be well-tolerated at the doses tested through 21 cycles of dosing in some patients. Most frequent adverse events were Grade 1 and 2, related to either AR inhibition or gastrointestinal tract irritation. In the patients evaluable for efficacy, rapid, deep and durable reductions in PSA were observed, regardless of previous chemotherapy status. In the first three cohorts, 90% of 10 patients achieved PSA50 and PSA90, 80% of patients achieved PSA90 in less than 90 days, and 70% of patients achieved PSA less than0.2mg/mL. The randomized Phase 2 dose expansion portion of the study is currently enrolling.