Valeo Pharma Inc. (TSX:VPH, OTCQB:VPHIF) said it has entered into a Commercial Services Agreement with Veru Inc for the latter’s novel dual anti-viral and anti-inflammatory agent sabizabulin in Canada.
Sabizabulin targets the treatment of hospitalized moderate-to-severe COVID-19 patients at high risk for acute respiratory distress syndrome (ARDS) and death, the pharmaceutical company said.
"Provincial healthcare systems across the country are still battling with high numbers of COVID-19 hospitalized patients and related deaths,” Valeo CEO Steve Saviuk said in a statement.
“In a pivotal Phase 3 study, sabizabulin demonstrated a statistically significant and clinically meaningful 55.2% reduction in deaths compared to placebo. It also showed a significant reduction of days in ICU, days on mechanical ventilation and days in hospital," he added.
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"Veru plans to pursue an expedited review process with the Canadian healthcare authorities with the objective of making sabizabulin available in Canada at the earliest time possible," Saviuk revealed.
The sabizabulin Phase 3 COVID-19 clinical trial was a double-blind, randomized, placebo-controlled trial conducted in 204 hospitalized COVID-19 patients with moderate-to-severe COVID at high risk for ARDS and death, Valeo said.
Treatment with 9 mg of sabizabulin once daily resulted in a clinically meaningful and statistically significant 55.2% relative reduction in deaths compared to placebo. The results of the interim analysis of the Phase 3 COVID-19 study have been published in The New England Journal of Medicine (NEJM) Evidence, Valeo noted.
Veru submitted a request for emergency use authorization to the US FDA in June 2022. In Canada, it plans to submit its application to Health Canada via the "NDS CV" submission type, which has been created for New Drug Submissions that seek approval on the basis of any of the specific requirements including COVID-19, Valeo added.
Veru is a biopharmaceutical company focused on developing novel medicines for COVID-19 and other viral and ARDS-related diseases and for the management of breast and prostate cancers.
Valeo Pharma is a fast-growing pharmaceutical company dedicated to the commercialization of innovative prescription products in Canada with a focus on respirology/allergy, ophthalmology and specialty products. Headquartered in Kirkland, Quebec, the company has the full capability and complete infrastructure to register and properly manage its growing product portfolio through all stages of commercialization.
Contact the author at jon.hopkins@proactiveinvestors.com