FDA Has Granted Veru a Pre-Emergency Use Authorization Meeting Date for Positive Sabizabulin Phase 3 COVID-19 Study

Veru Inc. recently announced the FDA has granted the company a pre-Emergency Use Authorization (EUA) meeting on May 10, 2022, for the positive Phase 3 COVID-19 study for sabizabulin.

“We want to keep our investors informed of the important steps as we proceed through the EUA process. We appreciate FDA’s actions to expedite this process as COVID-19 cases are on the rise again,” said Mitchell S. Steiner MD, Chairman, President, and Chief Executive Officer of Veru Inc.

Veru is a biopharmaceutical company focused on developing novel medicines for COVID-19 and other viral and ARDS-related diseases and for the management of breast and prostate cancers.

A double-blind, randomized, placebo-controlled Phase 3 COVID-19 clinical trial was conducted in approximately 210 hospitalized COVID-19 patients with moderate to severe COVID (≥ WHO 4) at high risk for ARDS and death. The primary endpoint was the proportion of deaths by Day 60. Based on a planned interim analysis of the first 150 patients to complete 60 days of follow-up, the Independent Data Monitoring Committee unanimously halted the study for overwhelming efficacy and safety. Treatment with sabizabulin 9mg once daily, an oral, first-in-class, new chemical entity, cytoskeleton disruptor that has dual anti-inflammatory and antiviral properties, resulted in a clinically meaningful and statistically significant 55% relative reduction in deaths. The company is seeking FDA emergency use authorization. FDA granted Fast Track designation to the company’s COVID-19 program in January 2022.

The company’s late-stage breast cancer development portfolio comprises enobosarm, a selective androgen receptor targeting agonist, and sabizabulin.

Current studies on the two drugs include:

• Enrolling Phase 3 ARTEST study of enobosarm in androgen receptor positive, estrogen receptor positive, and human epidermal growth factor receptor two negative (AR+ ER+ HER2-) metastatic breast cancer with AR ≥ 40% expression (third-line metastatic setting), and which has been granted Fast Track designation by the FDA.
• Enrolling Phase 3 ENABLAR-2 study of enobosarm + abemaciclib (a CDK 4/6 inhibitor) combination in AR+ ER+ HER2- metastatic breast cancer with AR ≥ 40% expression (second-line metastatic setting). The Company and Eli Lilly and Company have entered into a clinical study collaboration and supply agreement for the ENABLAR-2 study. Lilly will supply Verzenio (abemaciclib).
• Planned Phase 2b study of sabizabulin in AR+ ER+ HER2- metastatic breast cancer with AR < 40% expression (third-line metastatic setting).

Veru’s late-stage prostate cancer portfolio comprises sabizabulin, VERU-100, a long-acting GnRH antagonist, and zuclomiphene citrate, an oral nonsteroidal estrogen receptor agonist.

Current studies on these drugs include:

• Enrolling Phase 3 VERACITY study in metastatic castration and androgen receptor targeting agent resistant prostate cancer prior to IV chemotherapy.
• Enrolling Phase 2 dose-finding study of VERU-100 in advanced hormone sensitive prostate cancer.
• Planned Phase 2b study of zuclomiphene citrate to treat hot flashes in men with advanced prostate cancer undergoing androgen deprivation therapy.

Veru also has a commercial sexual health division – Urev, the proceeds of which help fund its drug development programs, comprised of 2 FDA approved products:

• ENTADFI (finasteride and tadalafil) capsules for oral use, a new treatment for benign prostatic hyperplasia, for which commercialization launch plans are underway.
• FC2 Female Condom (internal condom), for the dual protection against unplanned pregnancy and the transmission of sexually transmitted infections which is sold in the US and globally.