Veru posted positive interim Phase III data from its late-stage study assessing oral antiviral sabizabulin in hospitalized COVID-19 patients. Here’s more about it.
Oral antiviral for COVID19 was long-awaited to treat hospitalized patients.
Shares of Veru, Inc. soared nearly 200% after the Florida-based company announced its Phase III COVID-19 antiviral treatment was halted early based on positive efficacy following an Independent Data Monitoring Committee’s recommendation.
On Monday morning, Veru posted positive interim Phase III data from its late-stage study assessing the oral antiviral sabizabulin in hospitalized COVID-19 patients at high risk for Acute Respiratory Distress Syndrome (ARDS). Interim data showed that the oral antiviral demonstrated a 55% reduction in deaths compared to placebo in moderate-to-severe hospitalized patients. The results were considered statistically significant and statistically meaningful, the company said.
What was Found in Phase III Study of Oral Antiviral Sabizabulin?
The Phase III study assessed 210 hospitalized patients who were diagnosed with moderate to severe COVID-19 considered at high risk for ARDS and possibly death. Patients were randomized to receive either a 9 mg dose of oral antiviral sabizabulin or placebo. The trial also allowed patients in both treatment groups to receive standard-of-care treatments, which included Gilead Sciences’ remdesivir, dexamethasone, anti-IL6 receptor antibodies and JAK inhibitors. The interim analysis was conducted following the randomization of the first 150 patients. The primary efficacy endpoint was the proportion of patients that died by Day 60.
Veru noted that treatment with sabizabulin demonstrated a 55% relative reduction in deaths in the intent to treat population. The oral antiviral sabizabulin-treated group had a 20% mortality rate compared to a 45% mortality rate in the placebo group. The secondary efficacy endpoints from the Phase III study are still being analyzed, the company said.
Veru also noted that sabizabulin was well-tolerated in patients.
Based on the results, the company plans to meet with the U.S. Food and Drug Administration to discuss next steps to seeking emergency use authorization for sabizabulin, which previously received Fast Track designation from the regulatory agency.
Veru Chief Scientific Officer Gary Barnette said the thing that makes the findings highly relevant is that the pharmacological activity of oral antiviral sabizabulin is independent of COVID-19 variant type. The country has seen multiple variants of COVID-19, including most recently the highly infectious Omicron variant, as well as the Delta variant that was not as contagious but led to worsening symptoms of the virus.
“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,” Barnette said in a statement.
Should it be approved or authorized under EUA, oral antiviral sabizabulin would join other antiviral drugs such as remdesivir, marketed as Veklury, along with Merck’s molnupiravir and Pfizer’s Paxlovid. Both the Merck and Pfizer drug were authorized to treat patients with mild-to-moderate COVID-19. The Gilead drug is not an oral treatment, but rather delivered via infusion.
Mitchell Steiner, chairman, president and chief executive officer of Veru, sad the Phase III data represents a milestone in the ongoing fight against COVID-19, particularly in hospitalized patients with moderate to severe illness.
“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,” Steiner said in a statement.
Veru has ramped up manufacturing of oral antiviral in order to meet commercial demand and is in the process of discussing potential purchase agreements with the U.S. government. The stock is up more than 196% based on the announcement. Shares closed at $5.95 on Friday and are now trading at $12.48.
