Positive Updated Data From Phase 1b/2 Study in Men with Metastatic Castration Resistant Prostate Cancer
Florida-based Veru Inc. announced on September 20, 2021, that updated clinical data from the positive Phase 1b/2 study of sabizabulin (VERU-111) in 80 men with metastatic castration-resistant prostate cancer who have progressed on at least one novel androgen receptor targeting agent were presented at the European Society for Medical Oncology Congress 2021.
Sabizabulin is a new oral chemical entity representing a novel class of agents that target unique binding sites on microtubules to disrupt the cytoskeleton and androgen receptor transport.
As for efficacy, combining patients in Phase 1b/2 study who received 63 mg sabizabulin daily with measurable metastatic disease at baseline (PCWG3 criteria), the median rPFS is estimated to be approximately 7.4 months (3.2 – 30.0+ months) as five patients remain on the study of which two of which have been on sabizabulin without tumor progression for more than two years.
In the Phase 1b/2 population with measurable disease at baseline per RECIST 1.1, the Overall Response Rate (ORR) was 21%.
“These updated findings from our clinical study of sabizabulin continue to support the potential role of sabizabulin in filling a growing unmet medical need in the treatment of men with metastatic prostate cancer that have tumor progression with androgen deprivation and novel androgen receptor targeting agent therapy, but before IV chemotherapy," said Dr. Mitchell S. Steiner, Chairman, President, and CEO of Veru Inc., in a press release.
"Based on this Phase 1b/2 study, sabizabulin has a safety profile similar to what has been reported in the literature for novel androgen receptor targeting agents and with promising efficacy."
"We are greatly anticipating the results of our ongoing Phase 3 VERACITY study, which is enrolling in 45 clinical centers in the United States.”
Veru Inc. (NASDAQ: VERU) is an oncology biopharmaceutical company focusing on developing novel medicines to manage prostate cancer and breast cancer.