Reunion Neuroscience Inc. (NASDAQ: REUN, TSX: REUN) (“Reunion” or
“the Company”), a biopharmaceutical company committed to developing
innovative and patented therapeutic solutions for underserved
mental health conditions, today announced that the Company has
completed the interim data analysis for its Phase 1 clinical trial
with lead asset RE104, a unique 4-OH-DiPT prodrug. RE104 is a
proprietary, novel serotonergic psychedelic compound that Reunion
is developing as a potential fast-acting and durable treatment for
patients suffering from postpartum depression and other mental
health conditions.
In this first-in-human, Phase 1 study, RE104 was shown to be
safe and well tolerated, with no serious or severe adverse events.
The interim analysis included 32 healthy volunteers across four
ascending dose cohorts, with two of the eight subjects in each
cohort receiving placebo. RE104 showed robust and pervasive
pharmacodynamic effects with a shorter duration of psychedelic
experience relative to published data with psilocybin
(approximately three to four hours for RE104 versus six to eight
hours for psilocybin).1-2
Reunion also identified a dose level whereby the majority of
participants receiving a single administration of RE104 achieved a
“complete mystical experience,” defined as a score of at least 60
percent in each of the four domains of the validated Mystical
Experience Questionnaire (MEQ30). A complete mystical experience
has been shown to correlate with psychedelic treatment responses in
clinical trials of patients with depression, anxiety and substance
use disorder.3-5
Reunion plans to share results from its Phase 1 study with the
U.S. Food and Drug Administration (FDA) as part of a
pre-Investigational New Drug (IND) meeting in preparation for Phase
2 development in postpartum depression. The Company will also
submit the data to an upcoming 2023 major medical congress.
While completing the preplanned interim analysis, and per the
recommendation of the Safety Review Committee (SRC), Reunion has
continued with dose escalation and initiated a fifth cohort. The
Phase 1 protocol also includes the option to dose a sixth cohort
with eight subjects should the SRC or the Company seek additional
safety, pharmacokinetics and pharmacodynamics data.
“We are extremely encouraged by the interim data from our Phase
1 clinical trial, as we’ve been able to identify a dose at which
most participants had a short-duration, but complete, mystical
experience without any serious or severe adverse events,” said Greg
Mayes, President and CEO, Reunion Neuroscience. “We are confident
that this data provides robust justification for selecting a dose
of RE104 that could yield clinical efficacy in the treatment of
postpartum depression.”
Mr. Mayes continued, “Innovation in the development of mental
health treatment is severely lacking and has failed to provide
meaningful change in how we approach these all-too-common
conditions, especially with respect to women’s mental health. We
are eager to introduce a new psychedelic compound with significant
potential advantages for these patients. The Company looks forward
to unveiling the full Phase 1 dataset in the first half of 2023 and
will continue to forge ahead in our mission to transform mental
health treatment for the millions of people suffering
worldwide.”
Mr. Mayes will discuss these results as part of his Biotech
Showcase presentation in San Francisco, taking place on Monday,
Jan. 9, at 2 p.m. PT.
1 Carbonaro TM, Johnson MW, Hurwitz E, Griffiths RR.
Double-blind comparison of the two hallucinogens psilocybin and
dextromethorphan: similarities and differences in subjective
experiences. Psychopharmacology (Berl). 2018;235(2):521-534. doi:
10.1007/s00213-017-4769-4. Epub 2017 Nov 7.
2 Goodwin GM, Aaronson ST, Alvarez O et al. Single-dose
psilocybin for a treatment-resistant episode of major depression. N
Engl J Med. 2022;187:1637-48.
3 Barrett FS, Johnson MQ, Griffiths RR. Validation of the
revised Mystical Experience Questionnaire in experimental sessions
with psilocybin. J Psychopharmacol. 2015;29(11):1182-1190.
4 Yaden DB and Griffiths RR. The subjective effects of
psychedelics are necessary for their enduring therapeutic effects.
ACS Pharmacol Transl Sci. 2021;4(2):568-572.
5 Garcia-Romeu A, Griffiths RR, Johnson MW.
Psilocybin-occasioned mystical experiences in the treatment of
tobacco addiction. Current Drug Abuse Reviews. 2014;7:157-164
About Reunion Neuroscience Inc.Reunion is
committed to developing innovative therapeutic solutions for
underserved mental health conditions. The Company’s lead asset,
RE104, is a proprietary, novel serotonergic psychedelic compound
being developed as a potential fast-acting and durable treatment
for patients suffering from postpartum depression and other mental
health conditions. The U.S. Patent and Trademark Office has granted
the Company a patent for the claims related to RE104, granting it
exclusive rights to the composition of matter, use and
manufacturing of a family of hemi-ester compounds of
hydroxytryptamines, including RE104. The patent will provide
protection until 2041. Reunion is also developing the RE200 series,
which includes compounds with potential for more selective
serotonin receptor activity with reduced psychoactivity for
potential use in more chronic treatment paradigms and
indications.
Cautionary Note Regarding Forward-Looking
Information This release includes forward-looking
information (within the meaning of Canadian securities laws and
within the meaning of the United States Private Securities
Litigation Reform Act of 1995) regarding Reunion and its business.
Often but not always, forward-looking information can be identified
by the use of words such as "expect", "intends", "anticipates",
“plans”, "believes" or variations (including negative variations)
of such words and phrases, or state that certain actions, events or
results "may", "could", "would", “should” or "will" be taken, occur
or be achieved. Such statements are based on the current
expectations and views of future events of the management of
Reunion and are based on assumptions and subject to risks and
uncertainties, many of which are beyond Reunion’s control. Although
the management of Reunion believes that the assumptions underlying
these statements are reasonable, they may prove to be incorrect.
The forward-looking events and circumstances discussed in this
release may not occur and could differ materially as a result of
known and unknown risk factors and uncertainties affecting the
companies, including the funds available to Reunion and the use of
such funds, the timing, completion and potential outcome of testing
and research on Reunion’s drug trial candidates, RE104 and the RE
200 Series, including the ability to recruit patients, to retain
and identify clinical partners, and to optimize dosage amounts, the
likelihood and ability of Reunion to complete an investigational
new drug application and obtain regulatory approvals, as required,
prior to initiating further clinical trials for RE104 and molecules
within the RE200 Series, the ability of Reunion to meet eligibility
requirements for clinical testing and through to more complex
clinical trials, the ability of Reunion to protect and expand its
intellectual property portfolio, the performance of Reunion’s
affiliate, Field Trip Health & Wellness Ltd., the ability of
Reunion to produce and supply its drug trial candidates, market
conditions, economic factors, management's ability to manage and to
operate the business, the equity markets generally and this and
other Risk Factors disclosed in Reunion’s public filings available
on the SEDAR website at www.sedar.com and on the EDGAR section of
the SEC’s website at www.sec.gov. Although Reunion has attempted to
identify important factors that could cause actual actions, events
or results to differ materially from those described in
forward-looking statements, there may be other factors that cause
actions, events or results to differ from those anticipated,
estimated or intended. Accordingly, readers should not place undue
reliance on any forward-looking statements or information. No
forward-looking statement can be guaranteed. Except as required by
applicable securities laws, forward-looking statements speak only
as of the date on which they are made (or such earlier date, if
identified) and Reunion does not undertake any obligation to
publicly update or revise any forward-looking statement, whether as
a result of new information, future events, or otherwise.
Additional information relating to Reunion, including its Annual
Information Form and Risk Factors, can be located on the SEDAR
website at www.sedar.com and on the EDGAR section of the SEC’s
website at www.sec.gov.
This press release does not constitute an offer to sell or the
solicitation of an offer to buy securities.
Neither the Toronto Stock Exchange, nor its Regulation Services
Provider, have approved the contents of this release or accept
responsibility for the adequacy or accuracy of this release.
CONTACTS:
Reunion Neuroscience:Greg MayesPresident &
CEO(215) 696-9659gmayes@reunionneuro.com
Media Contact:Shana MarinoKCSA Strategic
Communications(347) 487-6189reunion@kcsa.com
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