Valeo Pharma and Veru have signed a commercial services agreement in Canada for sabizabulin as a treatment for Covid-19.
A new dual antiviral and anti-inflammatory agent, sabizabulin is an oral, microtubule disruptor.
Go deeper with GlobalData
It is being evaluated for treating hospitalised adult Covid-19 patients with moderate to severe disease who are at increased risk of acute respiratory distress syndrome (ARDS) and mortality.
A randomised, placebo-controlled, double-blind Phase III clinical trial of sabizabulin was carried out in 204 Covid-19 patients in the hospital setting.
The proportion of mortality by day 60 was the trial’s primary endpoint.
See Also:
Due to clear clinical efficacy without any safety concerns, the Independent Data Monitoring Committee stopped the trial.
How well do you really know your competitors?
Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.
Thank you!
Your download email will arrive shortly
Not ready to buy yet? Download a free sample
We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form
By GlobalDataThe committee’s decision was based on the interim assessment of the first group of 150 randomised study subjects.
According to the findings, a 9mg once-a-day dose of sabizabulin showed a clinically meaningful and statistically significant relative decline of 55.2% in morality versus placebo.
Veru intends to file an application through the ‘NDS CV’ submission type with Health Canada for the therapy.
In June, Veru sought emergency use authorization (EUA) from the US Food and Drug Administration (FDA) for the therapy.
Valeo Pharma CEO Steve Saviuk said: “In a pivotal Phase III 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.
“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.”
This July, the European Medicines Agency’s Emergency Task Force began a review of sabizabulin for treating Covid-19.
