The study was a long-term, double-blind, placebo-controlled, crossover trial evaluating the efficacy of fexapotide in 391 men with BPH. Patients were initially given placebo, followed by a crossover to either fexapotide or other conventional BPH treatments. The number of patients who subsequently received surgical treatment after the crossover during the next 2–3 years for their BPH symptoms were analyzed.
Study findings showed an 82–95% reduction in the number of patients who required surgery after a crossover to fexapotide, as compared to patients who received a crossover to conventional BPH treatments (P<0.0001). A favorable safety profile was observed for fexapotide, including the lack of sexual side effects. Further analysis of the study is ongoing, with detailed results expected to be available in the near future.
The Company expects to submit a regulatory approval application for fexapotide in the next 1–2 quarters.
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