Reunion Neuroscience Announces Publication of Results from Early Preclinical Studies Demonstrating the Potential of RE104 for Development in Depressive Disorders
20 Mayo 2024 - 6:30AM
Reunion Neuroscience Inc., a clinical-stage biopharmaceutical
company committed to pushing the boundaries of neuroscience, today
announced the publication of the results of preclinical studies in
ACS Chemical Neuroscience that validate the decisions to pursue
RE104, a proprietary, patented prodrug of 4-OH-DiPT as a potential
therapeutic in depressive disorders. The paper, titled “RE104:
Synthesis and Activity of a Novel Serotonergic Psychedelic Prodrug
of 4-Hydroxy-N,N-diisopropyltryptamine,” was co-authored by Robert
Alexander, Ph.D., Reunion’s Chief Medical Officer, and Michael D.
Ehlers, M.D., Ph.D., Chief Scientific Officer and Venture Partner
at Apple Tree Partners, with Nathan Bryson, Ph.D., Reunion’s Chief
Scientific Officer, as senior author.
“Serotonergic psychedelic compounds have demonstrated
significant potential to treat a variety of mental health
disorders,” said Nathan Bryson, Ph.D., Chief Scientific Officer of
Reunion. “The preclinical data published in ACS Chemical
Neuroscience was the impetus for selecting 4-OH-DiPT as the
psychedelic substrate at the core of our development program, as
well as the choice of the RE104 prodrug strategy for its delivery.
The findings present evidence supporting our target profile of an
antidepressant drug product with reproducible pharmacokinetics, a
short duration of psychoactivity, as well as fast-onset and durable
action in depression.”
“The data observed in these preclinical studies suggest that
RE104 could potentially provide life-changing benefits to the large
population of patients with underserved mental health disorders,
including in postpartum depression, Reunion’s lead indication,”
said Dr. Robert Alexander, Ph.D., Chief Medical Officer of Reunion.
“The preclinical models were affirmed in a Phase 1 Study in healthy
volunteers and we now look forward to evaluating RE104 in patients
with postpartum depression in our RECONNECT Phase 2 clinical trial,
which is expected to begin enrolling patients this quarter.”
Study Results
RE104 is a 4-OH-DiPT prodrug comprising a glutarate pro-moiety
that cleaves rapidly in situ, providing excellent bioavailability
of the active drug shortly after administration. The newly
published study describes the synthesis, as well as the chemical,
preclinical, and translational characterization of RE104, including
conversion to 4-OH-DiPT and subsequent metabolism in vivo. In a
forced swim model of behavior to assess antidepressive activity,
RE104 demonstrated efficacy similar to a psilocybin analog at Day
7, 14 and 28. This study used RE109, a psilocin prodrug of similar
structure to RE104, which is also described in the paper. The
article is open-source and can be found at the following link:
https://doi.org/10.1021/acschemneuro.4c00058.
RE104 and Clinical Programs
The Company’s lead asset, RE104, is a proprietary, potential
best-in-class, patented prodrug of 4-OH-DiPT. RE104 targets the
serotonin 2A receptor (5HT2AR), which is the recognized target for
the antidepressant effects of psychedelic compounds. As psychedelic
drugs require monitoring by trained healthcare providers, per
recent FDA Guidance (June 2023), Reunion designed RE104 to deliver
a short duration psychedelic experience and it requires only about
half a day in-clinic, a significantly shorter time commitment than
required for longer duration psychedelics, like psilocybin and
MDMA.
In a Phase 1 study, RE104 produced a psychedelic, psychoactive
state similar in intensity and quality to psilocybin, but lasting
only about half the time (3-4 hours) while demonstrating a similar,
favorable safety profile.
A Phase 2, Multicenter, Randomized, Double-Blind,
Parallel-Group, Active Dose-Controlled study evaluating RE104 in
moderate and severe PPD patients (The RECONNECT Trial) is expected
to start enrolling patients this quarter (NCT06342310). Results
from the RECONNECT Trial are expected in Q2 2025.
Reunion is actively investigating the use of RE104 in additional
neuropsychiatric indications, including adjustment disorder in
cancer patients, where there remains a significant unmet need that
is not addressed by the current standard of care.
About Reunion Neuroscience Inc.
Reunion Neuroscience is committed to pushing the boundaries of
neuroscience to develop innovative therapeutic solutions for
postpartum depression (PPD) and other underserved mental health
disorders. In August of 2023, Reunion Neuroscience was acquired by
MPM BioImpact, a world-leading biotechnology investment firm with
three decades of experience creating and investing in innovative
biotechnology companies seeking to deliver transformative therapies
to patients. As part of the MPM BioImpact portfolio, the Company is
evaluating its lead asset, RE104, a proprietary, potential
best-in-class, serotonergic psychedelic compound and the only
4-OH-DiPT prodrug in clinical development, as a potential treatment
for postpartum depression, (NCT06342310), that could provide rapid
symptom relief and durable efficacy. Reunion is actively
investigating the use of RE104 in additional neuropsychiatric
indications where there remains a significant unmet need that is
not addressed by the current standard of care.
For more information about the company, visit
https://reunionneuro.com.
For further information:
Media Inquiries:Sarah Sutton/Lily
Overacker(518) 932-3680reunion@argotpartners.com