ZYUS Life Sciences Corporation Announces Positive Phase I Clinical Trial Results for Trichomylin® Softgels
21 November 2023 - 11:45PM
Business Wire
Completion of Phase 1 and Supportive
Preclinical Data Will Assist in Ongoing Phase 2 Clinical
Development of ZYUS’ Lead Drug Product Candidate
ZYUS Life Sciences Corporation ("ZYUS" or the “Company”) (TSX-V:
ZYUS), a Canadian-based life sciences company leading scientific
research and global development of innovative cannabinoid-based
pharmaceutical drug products, is pleased to announce receipt of the
final clinical study report and positive results respecting its
Phase 1, first-in-human (“FIH”) Clinical Trial for its lead drug
product candidate, Trichomylin® softgels.
About Trichomylin Softgels
Trichomylin softgels, a first-in-class drug product candidate
formulated with a proprietary fixed-dose combination, has been
specifically designed for the management of chronic pain. Its
unique mechanism of action targets the endocannabinoid system
distinguishing it from current pain management therapies, offering
a novel approach in addressing chronic pain by delivering a
balanced ratio of three cannabinoids - cannabidiol (“CBD”),
cannabichromene (“CBC”) and delta-9-tetrahydrocannabinol
(“THC”).
About the Trial
Study Z-TRI-10001 (NCT04867057), conducted through ZYUS’
wholly-owned subsidiaries, ZYUS Life Sciences Inc. and ZYUS Life
Sciences Australia Pty. Ltd., was a Phase 1, FIH, randomized,
double-blind, placebo-controlled, single and multiple ascending
dose study designed to evaluate the safety, tolerability,
pharmacokinetics, pharmacodynamics and food effect of Trichomylin
softgels in healthy adult participants. A total of 41 healthy adult
participants were enrolled in this study, with 31 participants in
the active arm and 10 participants in the placebo arm. The Clinical
Trial results confirmed that Trichomylin softgels were well
tolerated and had a favorable safety profile, with no Serious
Adverse Events (“SAEs”), no dose-limiting toxicities, and no trial
suspension reported. Further, there was no indication of
neurocognitive impairment, altered state of consciousness and no
detrimental impact on overall well-being in participants based on
the standard validated questionnaires. The Clinical Trial achieved
a high rate of participant retention, with 97.5% of the enrolled
participants completing the study, showcasing the feasibility,
subject acceptability and engagement, and high quality of the
study. The most commonly reported Treatment Emergent Adverse Events
(“TEAEs”) were Euphoric Mood, Somnolence, and Fatigue, all of which
were also reported with the placebo. The effect of food on the
safety and tolerability of Trichomylin softgels was also assessed
at a single dose level, showing no apparent effect on the safety
profile of Trichomylin softgels. The evaluation of preliminary
efficacy of Trichomylin softgels in adult patients with moderate to
severe chronic osteoarthritis pain will be completed in a separate
Clinical Trial.
Key highlights respecting Trichomylin softgels and the Phase
1 Clinical Trial include:
- Safety and Tolerability: Trichomylin softgels exhibited
favourable safety and tolerability profiles, with no SAEs, no
dose-limiting toxicities, and no trial suspension reported.
- Unique Mechanism of Action: Trichomylin softgels target the
endocannabinoid system, a unique mechanism of action that sets it
apart from conventional pain management therapies.
- Patient Retention: The trial achieved a high rate of
participant retention, with 97.5% of the enrolled participants
completing the study, showcasing the feasibility, subject
acceptability and engagement and high quality of the study.
- Patent Protection: The Trichomylin softgels formulation has
received patent protection in Canada, Australia, Israel, India,
Korea, and South Africa. Additionally, patent applications have
been filed in the U.S. and European Union, underlining the
uniqueness and innovation of this novel fixed-dose combination
developed to alleviate chronic pain.
"The outcome of our Phase 1 Clinical Trial is extremely
promising and exemplifies our commitment to innovation, bringing us
one step closer to providing patients with an approved
pharmaceutical drug as an alternative to conventional pain
management therapies," said Brent Zettl, President and Chief
Executive Officer of the Company. "In less than five years, we have
advanced from the initial phases of conceptualizing and refining
the formulation to the successful completion of the Phase 1
Clinical Trial for Trichomylin softgels. This swift advancement is
a testament to our deep expertise and unwavering commitment to
delivering first-in-class and best-in-class drugs to patients
worldwide."
Positive Phase 1 results and supportive pre-clinical data will
assist ZYUS in its ongoing Phase 2 clinical development of
Trichomylin softgels and further strengthens ZYUS’ commitment to
secure regulatory approvals and ultimately bring this innovative
therapy to patients suffering from chronic pain.
About ZYUS Life Sciences Corporation
ZYUS is a publicly traded Canadian-based life sciences company
focused on the global development and commercialization of
regulated cannabinoid-based pharmaceutical drug product candidates.
Through clinical research, ZYUS is committed to furthering the
understanding of cannabinoids with the clinical development of its
pharmaceutical drug product candidates and intellectual property
activities to protect its novel formulations. Additionally, ZYUS is
dedicated to delivering high quality, cGMP/EU GMP-compliant
cannabinoid products to patients through the exempt global medical
market. The ZYUS vision is to reimagine the potential of pain
therapeutics by pursuing regulatory approval of cannabinoid
formulations and elevating cannabinoids as a standard of care in
pursuit of transformational impact on patients’ lives. ZYUS:
Advancing the Science of Well-Being. For additional information,
visit www.zyus.com or follow us on X (formerly known as Twitter)
@ZYUSCorp.
Cautionary Note Regarding Forward-Looking Statements
This news release contains “forward-looking information” within
the meaning of applicable securities laws relating to the Company’s
business, the Company’s ability to advance clinical research
activities and further operations, realize on its objectives and
obtain regulatory approval of cannabinoid-based pharmaceutical drug
product candidates, introduce products that act as alternatives to
current pain management therapies and advance Phase 2 clinical
development of Trichomylin softgels. Any such forward-looking
statements may be identified by words such as “expects”,
“anticipates”, “intends”, “contemplates”, “believes”, “projects”,
“plans” and similar expressions. Readers are cautioned not to place
undue reliance on forward-looking statements. Statements about,
among other things, the Company’s business, the Company’s ability
to advance clinical research activities and further operations,
realize on its objectives and obtain regulatory approval of
cannabinoid-based pharmaceutical drug product candidates, introduce
products that act as alternatives to current pain management
therapies and advance Phase 2 clinical development of Trichomylin
softgels are all forward-looking information. These statements
should not be read as guarantees of future performance or results.
Such statements involve known and unknown risks, uncertainties and
other factors that may cause actual results, performance or
achievements to be materially different from those implied by such
statements. Although such statements are based on management’s
reasonable assumptions, there can be no assurance that the Company
will be able to advance its clinical research activities and
further operations, realize its objectives and obtain regulatory
approval of cannabinoid-based pharmaceutical drug product
candidates, introduce products that act as alternatives to current
pain management therapies or advance Phase 2 clinical development
of Trichomylin softgels. The Company assumes no responsibility to
update or revise forward-looking information to reflect new events
or circumstances or actual results unless required by applicable
law. Neither the TSXV nor its Regulation Services Provider (as that
term is defined in the policies of the TSXV) accepts responsibility
for the adequacy or accuracy of this press release.
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For more information, please contact:
ZYUS Media Inquiries media@zyus.com 1-833-651-7723
ZYUS Investor Relations investors@zyus.com
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