Veru announces interim data from Phase 2 trial of Zuclomiphene
Veru announced positive top line data interim results from its Phase 2 clinical study of Zuclomiphene citrate, a nonsteroidal oral estrogen receptor agonist, for the treatment of androgen deprivation hormone therapy induced hot flashes, also known as vasomotor symptoms, in men who have advanced prostate cancer. The Phase 2 clinical study is a double-blind randomized placebo-controlled dose finding study evaluating daily oral doses of Zuclomiphene in men with advanced prostate cancer who have ADT induced moderate to severe hot flashes. The clinical study has a treatment duration of 12 weeks and is being conducted in 24 clinical centers in the United States. A topline interim analysis was performed in which 93 men with ADT-induced hot flashes were enrolled. The objectives of the study were to evaluate the estrogenic activity of Zuclomiphene on hot flashes, to confirm a no-effect dose and to evaluate the effect of a higher dose of Zuclomiphene on the frequency of moderate to severe hot flashes at Day 42. The topline interim clinical results demonstrate that a statistically significant decrease in moderate to severe hot flashes from baseline was observed in the 50mg treatment group. The 10mg treatment group, as expected, did not show a statistically significant reduction in hot flashes from baseline. Based on this result, the 10mg dose group is established as a no-effect dose as was planned for in the study. Furthermore, when comparing the 50mg treatment group versus the 10mg treatment group, a statistically significant reduction in the frequency of moderate to severe hot flashes at Day 42 is observed. Moreover, the observed estrogenic activity of the 50mg group was statistically different from 10mg and placebo group. Zuclomiphene appears to be well tolerated as there have been no reports of drug related serious adverse events nor drug related severe adverse events and no observations of adverse events of special interest, such as breast enlargement or pain, or venothromboembolic events in the safety database for the Phase 2 clinical study. Adverse events of special interest are side effects commonly seen with off label use of steroidal estrogens and progestins for hot flashes. The 50mg treatment group shows statistical and clinically meaningful reductions in moderate to severe hot flashes from baseline without any clinically relevant safety findings. The Company plans to meet with FDA for an End of Phase 2 meeting and following this discussion with FDA, advance Zuclomiphene into a pivotal Phase 3 clinical trial for the treatment of ADT-induced moderate to severe hot flashes in men with prostate cancer in the first half of 2020.