- In a Phase 3 cinical study interim analysis, sabizabulin
showed a 55.2% reduction in deaths compared to placebo in
hospitalized adult patients with moderate-severe COVID-19 who are
at high risk for ARDS
- Sabizabulin also showed significant reduction of days in
ICU, days on mechanical ventilation and days in the hospital
- Veru submitted a request for emergency use authorization to
FDA in June 2022
- Veru plans to request that Health Canada utliize the NDS-CV
(a prioritized, COVID specific review and authorization submission)
through the ACCESS Consortium regulatory pathway
MONTREAL, Sept. 14,
2022 /PRNewswire/ - Valeo Pharma Inc. (TSX: VPH)
(OTCQB: VPHIF) (FSE: VP2) ("Valeo" or the "Company"),
a Canadian pharmaceutical company, announced today that it has
entered into a Commercial Services Agreement with Veru Inc.
(Veru) for sabizabulin for COVID-19 in Canada. Sabizabulin is a novel dual antiviral
and anti-inflammatory agent being targeted for the treatment of
hospitalized moderate-severe COVID-19 patients at high risk for
acute respiratory distress syndrome (ARDS) and death.
"Provincial healthcare systems across the country are still
battling with high numbers of COVID-19 hospitalized patients and
related deaths. 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," said Steve Saviuk, CEO, Valeo. "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."
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 (≥ 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
halted the study 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 of the Phase 3 COVID-19 study have been
published in The New England Journal of Medicine (NEJM)
Evidence.
In June 2022, Veru submitted a
request for emergency use authorization to the US FDA. Veru will be
working with Health Canada and plans to submit its application via
the "NDS CV" submission type – which has been created for New Drug
Submissions (NDSs) that seek approval on the basis of any of the
specific requirements including COVID (CV). Veru will be requesting
that Health Canada utilize the ACCESS Consortium regulatory
pathway which supports increased harmonization across a number of
global health authorities.
About Veru
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.
The Company's late-stage breast cancer development portfolio
comprises enobosarm, a selective androgen receptor targeting
agonist, and sabizabulin. Veru's late-stage prostate cancer
portfolio comprises sabizabulin, VERU-100, a long-acting GnRH
antagonist, and zuclomiphene citrate, an oral nonsteroidal estrogen
receptor agonist.
About Valeo Pharma Inc.
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.
View original content to download
multimedia:https://www.prnewswire.com/news-releases/valeo-pharma-enters-into-canadian-commercial-services-agreement-with-veru-for-sabizabulin-in-hospitalized-adult-patients-with-covid-19-at-high-risk-for-acute-respiratory-distress-syndrome-ards-301624098.html
SOURCE Valeo Pharma Inc.