— Independent Data Monitoring Committee Unanimously Recommends that Phase 3 Clinical Trial for Sabizabulin for Treatment of Hospitalized COVID-19 Patients at High Risk for ARDS Be Stopped Early Due to Overwhelming Evidence of Efficacy —
— Sabizabulin Treatment Showed Statistically Significant and Clinically Meaningful 55% Reduction in Deaths Compared to Placebo in Moderate-Severe Hospitalized Patients (p=0.0029) —
— Sabizabulin Oral Daily Dosing was Well Tolerated with a Similar Safety Profile Compared to Placebo —
— Company to Meet with FDA to Seek Emergency Use Authorization —
–The Company will Host a Conference Call at 8:00 am ET to Discuss Results and Planned Next Steps —
MIAMI, April 11, 2022 — Veru Inc. (NASDAQ: VERU), an oncology biopharmaceutical company, today announced positive efficacy and safety results from a planned interim analysis of the double-blind, randomized, placebo-controlled Phase 3 COVID-19 clinical trial evaluating oral sabizabulin 9 mg versus placebo in 150 hospitalized COVID-19 patients at high risk for Acute Respiratory Distress Syndrome (ARDS). The Independent Data Safety Monitoring Committee unanimously recommended that the Phase 3 study be halted early due to efficacy, and they further remarked that no safety concerns were identified.
Phase 3 COVID-19 Trial Design
The Phase 3 COVID-19 study is a double-blind, randomized, placebo-controlled Phase 3 clinical trial evaluating oral, once-a-day dosing of sabizabulin 9 mg versus placebo in approximately 210 hospitalized moderate to severe COVID-19 patients (≥WHO 4) who were at high risk for ARDS and death. Patients were randomized in a 2:1 ratio to the sabizabulin treatment group versus placebo. Patients in both treatment groups were allowed to receive standard of care including remdesivir, dexamethasone, anti-IL6 receptor antibodies, and JAK inhibitors. The trial was conducted in the United States, Brazil, Colombia, Argentina, Mexico, and Bulgaria. COVID-19 infections treated in the study included the Delta and Omicron variants. A planned interim analysis was conducted in the first 150 patients randomized into the study. The primary efficacy endpoint was the proportion of patients that died by Day 60.
Clinical Efficacy and Safety Results
The prespecified primary endpoint was death at or before day 60. Sabizabulin treatment resulted in a clinically and statistically meaningful 55% relative reduction in deaths (p=0.0029) in the intent to treat population. Placebo group (n=52) had a 45% mortality rate compared to the sabizabulin-treated group (n=98) which had a 20% mortality rate. The secondary efficacy endpoints are still being analyzed at the time of this release.
Sabizabulin treatment was well tolerated in this patient population with no clinically relevant safety observations in the sabizabulin treated group compared to placebo.
Regulatory Discussions and Planning
The Company plans to meet with FDA to discuss next steps including the submission of an emergency use authorization application. As previously disclosed, the FDA granted Fast Track designation to the sabizabulin COVID-19 clinical program in January 2022, which the Company hopes will help streamline the emergency use authorization process.
The Company has scaled up manufacturing processes to produce commercial drug supply to address anticipated drug needs following potential FDA authorization.
The Company has been in discussions with BARDA and other US government agencies in an effort to secure an advance purchasing agreement of drug product for the U.S.
“This study represents a significant milestone in the global fight against COVID-19 as sabizabulin is the first drug to demonstrate a clinically and statistically meaningful reduction in deaths in hospitalized patients with moderate to severe COVID-19,” said Mitchell Steiner, M.D., Chairman, President and Chief Executive Officer of Veru. “We strongly believe that sabizabulin, with its dual anti-viral and anti-inflammatory properties which demonstrated positive efficacy and safety results in the Phase 3 COVID-19 study, can be that greatly needed oral therapy for hospitalized moderate to severe COVID-19 patients,” Dr. Steiner continued.
“What makes these findings more relevant is that the pharmacological activity of sabizabulin is independent of COVID-19 variant type. Pending upcoming discussion with FDA, this treatment option may be made available soon so we can be ready for when the next clinically important wave of COVID infections comes,” said Gary Barnette, PhD, Chief Scientific Officer of Veru.
“We expect new COVID-19 variant infections and new challenges in the treatment of hospitalized patients, particularly as the country heads into the fall and winter seasonal cycle. With the results of this Phase 3 COVID-19 study, we now have a treatment option for the sickest hospitalized COVID patients,” said Alan Skolnick, M.D., Principal Investigator with HD Research, who conducted this Phase 3 COVID-19 study at Memorial Hermann Memorial City Medical Center in Houston TX. “We have battled this pandemic for almost two and a half years now. A 55% reduction in deaths in hospitalized patients is tremendously meaningful to patients, their families, doctors, nurses, hospital staff and the communities they serve,” added Dr. Skolnick.
Event Details
The Company will host a conference call today at 8:00 am ET to discuss the positive efficacy and safety results from the interim analysis and next steps. Interested parties may access the call by dialing 1-800-341-1602 from the U.S. or 1-412-902-6706 from outside the U.S. and asking to be joined into the Veru Inc. call. The call will also be available through a live, listen-only audio broadcast via the Internet at www.verupharma.com. Listeners are encouraged to visit the website at least 10 minutes prior to the start of the scheduled presentation to register, download and install any necessary software. A playback of the call will be archived and accessible on the same website for at least three months. A telephonic replay of the conference call will be available, beginning the same day at approximately 12 p.m. (noon) ET by dialing 1-877-344-7529 for U.S. callers, or 1-412-317-0088 from outside the U.S., passcode 5820166, for one week.
About Veru Inc.
Veru is an oncology biopharmaceutical company with a principal focus on developing novel medicines for the management of breast and prostate cancers.
The Company’s late-stage breast cancer development portfolio comprises enobosarm, a selective androgen receptor targeting agonist, and sabizabulin, a cytoskeleton disruptor.
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.
- Planned 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).
The Company has determined that patients who have ≥ 40% androgen receptor nuclei staining by immunohistochemistry in their breast cancer tissue, a measure of AR expression, are most likely to respond to enobosarm. Consequently, Veru is developing a companion diagnostic test to determine a patient’s androgen receptor expression status and has partnered with Roche/Ventana Diagnostics, a world leader in oncology companion diagnostic tests, which will develop and, if it is approved, commercialize the AR companion diagnostic test.
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.
In addition, sabizabulin, which has dual antiviral and anti-inflammatory effects, has completed a Phase 3 COVID-19 clinical study for the treatment of hospitalized moderate to severe COVID-19 patients ( WHO 4) who were at high risk for ARDS and death. The Phase COVID-19 clinical study was stopped early for positive efficacy following a planned interim analysis. The Company is seeking an emergency use authorization.
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 U.S. and globally.