VANCOUVER,
BC, June 20, 2024 /CNW/ - Apex Labs
Ltd. (APEX or the Company), a pharmaceutical company
transforming the standard of mental health care with psilocybin is
pleased to announce the filing of an IND application with the U.S.
Food and Drug Administration (FDA) for APEX-002-B01-02, a
pioneering pharmacokinetics and driving simulator study of APEX-52
take home microdose psilocybin.
The study will be conducted at the
Yale School of Medicine using
their world-class DrivSim Lab's DSRI miniSim™ Research Driving
Simulator, with APEX acting as the study sponsor. "Designed to
enroll 55 participants, the study aims to shed light on crucial
driving data and understand the pharmacokinetics of
psilocybin—specifically, how long it takes for active blood levels
to become undetectable," says Principal Investigator
Barbara C. Banz, PhD from
Yale School of Medicine. "Furthermore,
it seeks to evaluate driving performance and vehicle control at
Cmax to establish when patients can drive safely following
dosing."
Findings from the study will be used to support
the development of PATHFINDER-52, APEX's 294 patient phase
2b clinical trial using APEX-52 take
home microdose psilocybin.
"This study is a cornerstone in terms of
informing our phase 3 study design and our robust labeling strategy
for APEX-52," says Greg Rutherford,
Chief Commercial Officer at Apex Labs. "Patients taking the current
standard of care in depression, SSRIs, are often recommended within
the label to avoid driving or using heavy machinery until they
are reasonably certain its ok to do so. Clear and measured
understanding of the interaction between psilocybin and the
ability to drive is fundamental for the safe integration of
microdosing APEX-52 into patients' daily lives."
Tyler Powell,
co-Founder and CEO of Apex Labs adds: "APEX is grateful for our
collaborative partnership with Yale. We want patients taking our
patent-pending APEX-52 capsule in the comfort of their own home to
understand how they can integrate the treatment into their daily
lives safely. This study represents a significant leap forward in
our mission to enhance patient care and safety in the use of
our subperceptual microdose drug asset."
About Apex Labs Ltd.
APEX is a patient-driven pharmaceutical company
focused on revolutionizing the standard of mental health care with
psilocybin. By bringing data supported, clinically evaluated drugs
to market for depression in PTSD, APEX's strategy is focused on
developing pharmaceutical products by evaluating safety and
efficacy across multiple indications alongside a robust Early
Access Program.
APEX sees Veterans as a patient base with the
most severe unmet need, supporting Veteran patients first and
expanding to broader global patient communities.
Visit apexlabs.com for more
information and follow APEX
on LinkedIn, Twitter and Instagram.
About the Yale Developmental Neurocognitive
Driving Simulation Research Center (DrivSim Lab)
The Yale
DrivSim Lab focuses on promoting safe driving by carrying out
multidisciplinary research to understand driver behavior and
identify factors that lead to motor vehicle crashes.
Visit:
https://medicine.yale.edu/emergencymed/research/labs/drivsim/ for
more information.
Forward-Looking
Statements
This release contains certain "forward-looking
statements" and certain "forward-looking information" as defined
under applicable Canadian securities laws. Forward-looking
statements and information can generally be identified by the use
of forward-looking terminology such as "may", "will", "expect",
"intend", "estimate", "anticipate", "believe", "continue", "plans"
or similar terminology. Forward-looking statements and information
are based on forecasts of future results, estimates of amounts not
yet determinable and assumptions that, while believed by management
to be reasonable, are inherently subject to significant business,
economic and competitive uncertainties and contingencies.
Forward-looking statements and information are subject to various
known and unknown risks and uncertainties, many of which are beyond
the ability to control or predict, that may cause the Company's
actual results, performance or achievements to be materially
different from those expressed or implied thereby, and are
developed based on assumptions about such risks, uncertainties and
other factors set out here in, including but not limited to:
receiving of Health Canada Dealers Licence; filing US
provisional patent, the Company evaluating the safety and efficacy
of APEX-52 (psilocybin) and APEX-90 (psilocybin) in treating
depression in Veterans and patients with Post-Traumatic Stress
Disorder; statements related to APEX-52 and APEX-90, including
manufacturing, dosing, and trial details; statements made by the
Company's executives with respect to Health Canada's Dealer's
Licence and capsule patent filing; the Company's efforts around the
Early Access Program; statements made relating to Canadian Veteran
patients; the inherent risks involved in the general securities
markets; uncertainties relating to the availability and costs of
financing needed in the future; the inherent uncertainty of cost
estimates and the potential for unexpected costs and expenses,
currency fluctuations; regulatory restrictions, liability,
competition, loss of key employees and other related risks and
uncertainties. The Company undertakes no obligation to update
forward-looking information except as required by applicable law.
Such forward-looking information represents managements' best
judgment based on information currently available. No
forward-looking statement can be guaranteed and actual future
results may vary materially. Accordingly, readers are advised not
to place undue reliance on forward-looking statements or
information.
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SOURCE Apex Labs Ltd.