Prostate Cancer Treatment Phase Three Study Launches

Miami-based Veru Inc. announced that it had enrolled the first patient in its Phase 3 VERACITY clinical trial of sabizabulin, an oral, first-in-class, new chemical entity, androgen receptor transport disruptor, for metastatic castration and androgen receptor targeting agent resistant prostate cancer.

The Phase 3 VERACITY clinical trial is an open-label, randomized, multicenter registration study to evaluate the efficacy and safety of sabizabulin 32mg oral daily dosing versus an alternative androgen receptor targeting agent for the treatment of chemotherapy naïve men with metastatic castration-resistant prostate cancer who have progressed on at least one androgen receptor targeting agent.

The primary endpoint is median radiographic progression-free survival, and key secondary endpoints are overall response rate, duration of objective response, overall survival, time to chemotherapy, and pain progression. The study is expected to enroll 245 patients and will be conducted in over 45 clinical sites across the USA.

Veru Inc. is an oncology biopharmaceutical company focusing on developing novel medicines for the management of prostate cancer and breast cancer.