Veru Receives FDA Agreement to Advance VERU-111 into Phase 3 Study in Hospitalized COVID-19 Patients at High Risk for Acute Respiratory Distress Syndrome (ARDS) - Seite 3

For secondary endpoints: in the Intent to Treat (ITT) population, VERU-111 reduced the proportion of patients who died on study from 30% (6/20) in the placebo group to 5.3% (1/19) in the VERU-111 treated group (p=0.044). This is an 82% relative reduction in mortality in the VERU-111 treated group. In an MITT population, VERU-111 showed a statistically significant and clinically meaningful reduction in days in ICU (VERU-111 patients at 3.00 ± 7.16 days versus placebo 9.55 ± 11.54; p=0.04). VERU-111 reduced the days on mechanical ventilation from an average of 5.4 days in the placebo group to 1.6 days in the VERU-111 treated group. VERU-111 was tolerated with a good safety profile.

VERU-111 and Standard of Care

During the study, the standard of care included treatment with remdesivir and/or dexamethasone under an Emergency Use Authorization. The use of remdesivir and dexamethasone did not have a significant effect on patient outcomes in the study. A subgroup analysis of patients that received standard of care was conducted. There were six patients in the entire study that did not receive standard of care of either remdesivir or dexamethasone (four in the VERU-111 treated group and two in the placebo group). In patients that did not receive the standard of care, VERU-111 treatment resulted in a statistically significant reduction in days in ICU (VERU-111 1.43 ± 3.96 days versus placebo 8.83 ± 13.07 days; p=0.024) and days on mechanical ventilation (VERU-111 zero days versus placebo 6.00 ± 10.57 days; p=0.0427). In the VERU-111 group on standard of care, no patient required mechanical ventilation on study.

About Veru Inc.
Veru Inc. is an oncology biopharmaceutical company with a focus on developing novel medicines for the management of prostate cancer and breast cancer. The Veru prostate cancer pipeline includes VERU-111, VERU-100, and Zuclomiphene citrate. VERU-111 is an oral, first-in-class, new chemical entity that targets, crosslinks, and disrupts alpha and beta tubulin subunits of microtubules for the treatment of metastatic castration and androgen receptor resistant prostate cancer. VERU-100 is a novel, proprietary peptide formulation designed to address the current limitations of commercially available androgen deprivation therapies (ADT) for advanced prostate cancer. Zuclomiphene citrate is an oral nonsteroidal estrogen receptor agonist being developed to treat hot flashes, a common side effect caused by ADT in men with advanced prostate cancer. The Veru breast cancer pipeline includes enobosarm for AR+/ER+/HER2- metastatic breast cancer and VERU-111 for taxane resistant metastatic triple negative breast cancer. Enobosarm is an oral, first-in-class, new chemical entity, selective androgen receptor agonist that targets and activates the androgen receptor in AR+/ER+/HER2- metastatic breast cancer without unwanted masculinizing side effects. VERU-111 is also being advanced into Phase 3 for the treatment of hospitalized patients with COVID-19 who are at high risk for acute respiratory distress syndrome.