- In the final analysis of the Phase 3 cinical study conducted
by Veru Inc., sabizabulin showed a 51.6% reduction in deaths
compared to placebo in hospitalized adult patients with moderate to
severe COVID-19 who are at high risk for ARDS
- Sabizabulin also showed a significant reduction of days in
ICU, days on mechanical ventilation and days in the
hospital
MONTREAL,
Jan. 26,
2023 /CNW Telbec/ Valeo Pharma Inc. (TSX: VPH)
(OTCQB: VPHIF) (FSE: VP2) ("Valeo" or the "Company"),
a fast-growing Canadian pharmaceutical company, announced today
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.
"Health Canada's
filing acceptance of Veru's NDS-CV application for sabizabulin is
the first important regulatory milestone in the drug approval
process. 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," said
Steve Saviuk, CEO. "We will continue
working closely with Veru to ensure, if approved, access to
sabizabulin at the earliest possible time."
The 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 (≥ WHO 4-supplemental oxygen) at high risk for
ARDS and death. The primary endpoint was the proportion of deaths
by Day 60. Patients in both treatment groups were allowed to
receive standard of care treatment, including remdesivir,
dexamethasone, anti-IL6 receptor antibodies and JAK inhibitors.
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 previously announced in September 2022 that Veru and Valeo had entered
into an agreement under which Valeo is the commercial partner for
Veru's product candidate sabizabulin for COVID-19 in Canada.
About Valeo Pharma
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 Valeo Pharma has
all the necessary capabilities and a complete infrastructure to
register and manage its growing product portfolio through all
stages of commercialization. For more information, please visit
www.valeopharma.com and follow us on LinkedIn and Twitter.
Forward Looking
Statements
This press release contains forward-looking
statements about Valeo's objectives, strategies and businesses that
involve risks and uncertainties. These statements are
"forward-looking" because they are based on our current
expectations about the markets we operate in and on various
estimates and assumptions. Actual events or results may differ
materially from those anticipated in these forward-looking
statements if known or unknown risks affect our business, or if our
estimates or assumptions turn out to be inaccurate.
SOURCE Valeo Pharma Inc.