Before U.S. markets opened for trading today, oncology-focused biopharmaceutical company Veru Inc. (VERU:NASDAQ), 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)."
Veru started off the days with a market cap of around $348.2 million with approximately 80.05 million shares outstanding and a short interest of about 4.1%.
Veru advised that due to the overwhelming efficacy and safety results achieved in the Phase 3 study the trial's Independent Data Safety Monitoring Committee unanimously recommended that the study be halted.
The company explained that the double-blind COVID-19 trial was set-up to evaluate a once-daily 9 mg dose of sabizabulin compared to placebo. The study included the data from approximately 210 hospitalized patients diagnosed with moderate to severe COVID-19 and who were considered to be at high risk for ARDS and death. Veru mentioned that the planned interim analysis included data from the first 150 randomized patients in the study and listed that the primary preestablished endpoint was the ratio of patients who had died within 60 days of hospitalization.
The firm said that the study included patients affected by both Delta and Omicron variants and was carried out in the U.S. and several other countries including Argentina, Brazil, Bulgaria, Colombia and Mexico. The company stated that "patients in the trial were randomized in a 2:1 ratio to the sabizabulin treatment group versus placebo." The firm added that both the patients who were treated with sabizabulin and those in the control group were also permitted to continue with other supplemental standard of care treatments including anti-IL6 receptor antibodies, dexamethasone, JAK inhibitors and remdesivir.
The company stated that in the Phase 3 COVID-19 trial patients who were given sabizabulin demonstrated a clinically and statistically meaningful 55% relative reduction in deaths compared to the non-treated population. The firm listed that while 45% of the 52 patients in the placebo group did not survive, 80% of the 98 patients in the sabizabulin-treated group had survived during over the course of the study.
Based upon the results gathered in the trial the company stated that it intends to meet with the U.S. Food and Drug Administration (FDA) to discuss proceeding forward with submission of an emergency use authorization. Veru indicated that in January 2022 the FDA granted Fast Track designation to the sabizabulin COVID-19 clinical program which should help expedite the emergency use approval.
Veru Inc.'s Chairman, President and CEO Mitchell Steiner, M.D., commented, "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…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."
The company's Chief Scientific Officer Gary Barnette, Ph.D. added, "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."
Alan Skolnick, M.D., Principal Investigator with HD Research and Conductor of the Phase 3 COVID-19 study at Memorial Hermann Memorial City Medical Center in Houston Tex. remarked, "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…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."
Veru Inc. is an oncology focused biopharmaceutical company based in Miami, Fla. that concentrates its efforts on the development of medicines for use in treating breast and prostate cancer. The company's late-stage breast cancer development portfolio includes a selective androgen receptor targeting agonist called enobosarm and its cytoskeleton disruptor known as sabizabulin, which offers dual antiviral and anti-inflammatory effects and now shows excellent potential for COVID-19 treatment in high-risk ARDS patients. In addition, the firm listed that "its late-stage prostate cancer portfolio comprises sabizabulin, VERU-100, a long-acting GnRH antagonist, and zuclomiphene citrate, an oral nonsteroidal estrogen receptor agonist."
Veru started off the days with a market cap of around $348.2 million with approximately 80.05 million shares outstanding and a short interest of about 4.1%. VERU shares opened nearly 38% higher today at $5.99 (+$1.64, +37.70%) over Friday's $4.35 closing price and reached a new 52-week high price this morning of $14.57. The stock has traded today between $5.68 and $14.57 per share and is currently trading at $12.33 (+$7.98, +183.45%).
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