Valeo Pharma Inc. (TSX:VPH, OTCQB:VPHIF) said that Health Canada has accepted for review Veru’s New Drug Submission (NDS-CV) for sabizabulin for COVID-19.
Sabizabulin is a novel dual antiviral and anti-inflammatory agent being developed for the treatment of hospitalized moderate to severe COVID-19 adult patients at high risk for acute respiratory distress syndrome (ARDS) and death, the company said.
In a statement, Steve Saviuk, Valeo Pharma’s CEO welcomed the news, calling it “the first important regulatory milestone in the drug approval process.”
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“Given the current number of hospitalized COVID-19 patients and the burden on provincial healthcare systems, there is a need to continually seek innovative treatment options. We will continue working closely with Veru to ensure, if approved, access to sabizabulin at the earliest possible time," he added.
In September 2022, Veru and Valeo entered into an agreement making Valeo the commercial partner for Veru’s product candidate sabizabulin for COVID-19 in Canada.
.A Phase 3 COVID-19 clinical trial of sabizabulin was a double-blind, randomized, placebo-controlled trial conducted in 204 hospitalized COVID-19 patients with moderate to severe COVID-19 at high risk for ARDS and death.
Based on a planned interim analysis of the first 150 patients randomized, the Independent Data Monitoring Committee unanimously recommended to halt the study early for clear clinical efficacy and no safety concerns were identified.
Treatment with sabizabulin 9 mg once daily, an oral, first-in-class, new chemical entity, microtubule disruptor that has dual anti-inflammatory and antiviral properties, resulted in a clinically meaningful and statistically significant 55.2% relative reduction in deaths compared to placebo.
The results of the interim analysis were published in The New England Journal of Medicine (NEJM) Evidence. In the final analysis of all 204 patients, sabizabulin demonstrated a statistically significant 51.6% relative reduction in deaths compared to placebo. Sabizabulin was well tolerated.
Valeo Pharma is a fast-growing Canadian pharmaceutical company dedicated to the commercialization of innovative prescription products in Canada with a focus on Respiratory/Allergy, Ophthalmology and Hospital Specialty Products. Headquartered in Kirkland, Quebec, the company has all the necessary capabilities and a complete infrastructure to register and manage its growing product portfolio through all stages of commercialization.
Contact the author at jon.hopkins@proactiveinvestors.com