VERU Inc. announced it has completed enrollment of 40 men with metastatic prostate cancer who have become resistant to at least one androgen receptor targeting agent for its phase 2 study of VERU-111.
A phase 2 study, designed to evaluate VERU-111 for the treatment of metastatic castration prostate cancer and disease that is resistant to novel androgen receptor targeting therapy, has completed enrollment, according to Veru Inc., the agent’s manufacturer.
The open-label, single-arm, phase 2 trial enrolled 40 men across 13 clinical sites in the United States.
“We are excited to have fully enrolled the phase 2 portion of the phase 1b/2 clinical trial evaluating the recommended 63 (milligram) oral daily continuous dosing of VERU-111 for metastatic castration and androgen receptor targeting agent resistant prostate cancer,” said Dr. Mitchell Steiner, chairman, president and chief executive officer of Veru, in company-issued press release.
The phase 2 trial will evaluate the efficacy and safety of VERU-111 – a novel androgen receptor targeting agent resistant prostate cancer –in men with metastatic prostate cancer who have become resistant to at least one androgen receptor targeting agent, including Zytiga (abiraterone) or Xtandi (enzalutamide), but prior to intravenous chemotherapy in the metastatic setting.
Radiographic imaging of progression-free survival, which is the time from treatment to disease worsening, is the main goal of the phase 2 study.
Patients are scheduled to receive a dose of 63 mg daily – which was the recommended dose that was selected from the phase 1b portion of the study that demonstrated the agent was well tolerated with no reports of neurotoxicity, hypersensitivity (allergic) reactions and neutropenia among 39 patients. Moreover, VERU-111 showed promising antitumor activity, with prostate-specific antigen (PSA) declines, objective tumor responses and durable responses.
Based on positive results from the phase 1b portion of the trial, and also from current results that have been observed in the open label phase 2 study, Veru Inc. noted that it met with the Food and Drug Administration (FDA). In July, the agency issued regulatory clarity on the pivotal phase 3 trial design for VERU-111 being evaluated in metastatic castration and novel androgen-blocking agent resistant prostate cancer.
In particular, the agency noted the trial design was acceptable. The open label, randomized, active control study using an alternative novel androgen blocking agent as the active control was found to be reasonable. Moreover, the FDA said that the primary end point will be radiographic progression-free survival in the pre-chemotherapy patient population.
“With the positive FDA input, we plan to submit the final phase 3 pivotal registration study to the FDA in (the fourth quarter of 2020) and meet with the (European Medicines Agency) in (the first quarter of 2021),” Steiner said.