Veru Inc. has announced the publication of positive Phase III results from its COVID-19 antiviral therapeutics that could lead to potential Emergency Use Authorization.
Veru Inc. shares were climbing rapidly in the early hours of trading Wednesday, up more than 16% after the company announced the publication of positive Phase III results from its COVID-19 antiviral therapeutic that could lead to potential Emergency Use Authorization.
Florida-based Veru said Phase III data showed sabizabulin, a novel dual antiviral and anti-inflammatory agent, demonstrated a 55.2% reduction in deaths in moderate to severe hospitalized patients compared to placebo. The results were both statistically significant and clinically meaningful, the company said.
In the study of 210 hospitalized moderate to severe COVID-19 patients, patients received sabizabulin plus standard of care treatment or placebo plus standard of care, which included remdesivir, dexamethasone, anti-IL6 receptor antibodies and JAK inhibitors, the company noted.
Additionally, sabizabulin hit its secondary endpoints, showing significant reductions in the number of days patients spent in the intensive care unit, as well as days spent on mechanical ventilation and total hospital days. Specifically, sabizabulin is being developed for the treatment of hospitalized moderate-severe COVID-19 patients at high risk for acute respiratory distress syndrome (ARDS). Data from the Phase III study was published in the New England Journal of Medicine (NEJM) Evidence.
Sabizabulin was well-tolerated, and the company noted it had a more favorable safety profile compared to placebo.
Based on the data, Veru submitted an Emergency Use Authorization to the U.S. Food and Drug Administration.
Gary Barnette, Ph.D., chief scientific officer of Veru and co-author of the data published in NEJMEvidence, expressed excitement over the late-stage data. He said the overall conclusion of the Phase III study is that “sabizabulin treatment has a clear mortality benefit compared to placebo in hospitalized COVID-19 patients at high risk for ARDS” patients who also received standard of care treatment.
“This landmark study published in The New England Journal of Medicine Evidence shows the high consistency of sabizabulin treatment to significantly reduce deaths across patient subgroups regardless of standard of care treatment received, baseline WHO scores, age, comorbidities, vaccination status, COVID-19 variant, or geography,” Dr. Mitchell Steiner, chairman, president and CEO of Veru and co-author of the NEJM Evidence publication, said in a statement. “We have submitted a request for emergency use authorization with FDA and are in discussions with other regulatory authorities across the world.”
Veru wasn’t the only company to announce positive data from a COVID-19 therapeutic. Pennsylvania-based Immunome, Inc. said its antibody cocktail, dubbed IMM-BCP-01, “retained activity” against the BA.4/5 and BA.2.12.1 subvariants in pseudovirus testing.
The antibody cocktail is in Phase Ib studies. It is being assessed in clinical trial sites where the predominant SARS-CoV-2 variants are BA.2.12.1, BA.4, BA.5 and BA.2. According to the U.S. Centers for Disease Control and Prevention, as of June 25, the BA.4, BA.5 and BA.2.12.1 subvariants of the Omicron variant represent more than 90% of the COVID-19 cases in the United States.
IMM-BCP-01 is a three-antibody cocktail with each antibody having a different mechanism of action. According to the company, IMM20190 binds to a composite epitope involving the receptor binding ridge and an area adjacent to the receptor-binding loop preventing binding to ACE2.
“We are pleased that IMM-BCP-01 retains effectiveness against the currently dominant BA.4/.5 and BA.2.12.1 subvariants,” Purnanand Sarma, Ph.D., president and CEO of Immunome, said in a statement. “Further, as several existing antibody treatments lose their potency against the Omicron subvariants, IMM-BCP-01 continues to retain activity against these variants in preclinical testing and we believe our cocktail has potential to play a significant role in managing the pandemic. We also look forward to announcing topline data from our Phase Ib clinical study in the second half of 2022.”
