Full Press Release Details
Therapeutics to Present New Preclinical Data on its Psilocybin Program at AASLD The Liver Meeting 2023
CORAL GABLES, Fla., October 11, 2023 /PRNewswire/
-- Relmada Therapeutics, Inc. (Nasdaq: RLMD), a late-stage biotechnology company addressing diseases of the central nervous system (CNS),
today announced that new preclinical data on its novel psilocybin will be highlighted in a poster presentation at
the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting 2023, being held November 10-14,
2023, in Boston, MA.
The data demonstrate the beneficial effect of
non-psychedelic/low dose psilocybin on multiple metabolic parameters in a rodent model of metabolic dysfunction-associated steatotic liver
disease (MASLD). Mice were fed a high fructose, high fat diet (HFHFD) for 17 weeks to induce MASLD, along with hyperglycemia, hyperlipidemia
and significant weight gain. One group of MASLD mice (N=10) was treated with low-dose (0.05 mg/Kg) psilocybin daily and a second (N=10)
with vehicle daily by oral gavage while continuing on HFHFD. Standard diet-fed mice (N=10) were used as controls. Body-weight and
food intake were assessed weekly.
Key statistically significant results in psilocybin-treated
mice relative to HFHFD vehicle-treated mice include:
0.05 mg/Kg psilocybin resulted in:
These pleiotropic metabolic effects were demonstrated
to be due, in part, to the 5-HT-2A serotonin receptor agonist activity of psilocybin, a mechanism distinct from, and potentially complementary
to, the incretin (GLP-1) class of agents.
Additionally, the results show that low-dose psilocin,
the pharmacologically active metabolite of psilocybin, reduces lipid accumulation in HepG2 cells in vitro in a 5-HT-2A dependent manner.
Relmada intends to enter human studies of its
proprietary, non-psychedelic/low dose modified-release formulation of psilocybin for metabolic indications. Leveraging the large amount
of safety data already publicly available on psilocybin, the Company plans to commence a single-ascending dose Phase 1 trial in obese
patients with steatotic liver disease in early 2024 to define the pharmacokinetic, safety and tolerability profile of Relmada's
modified-release psilocybin formulation in this population, followed by a Phase 2a trial in the same patient population to establish clinical
animal data are quite compelling and warrant further evaluation in the clinic," said Stephen Harrison, M.D., Founder and Chairman
of Pinnacle Clinical Research, and a world-renowned non-alcoholic steato-hepatitis (NASH) and metabolic disease expert. "There are
currently no approved drugs for MASLD, and these initial pre-clinical results support the therapeutic potential of non-psychedelic/low
dose psilocybin. Based on these data, non-psychedelic/low dose psilocybin could improve lipids and glucose with potential for fewer side
effects over other investigative treatment approaches such as GLP-1, glucagon, and GIP. A significant opportunity exists to treat MASLD
and associated metabolic disorders for a product with this profile"
Relmada acquired the development and commercial
rights to a novel psilocybin and derivative program from Arbormentis LLC in July of 2021. The original focus of the program was limited
to neurodegenerative diseases. Psilocybin has neuroplastogen effects that have the potential to ameliorate the consequences of
multiple neurodegenerative conditions. The pleiotropic metabolic effects of low-dose psilocybin were discovered while studying its neuroplastogen
potential in a rodent model deficient in neurogenesis - obese rodents maintained on a HFHFD. "Although the neurodegenerative
program continues according to plan, this new discovery opens a large opportunity to expand the program in the obesity and metabolic disease
area, potentially increasing the scope and diversification of Relmada's pipeline," said Sergio Traversa, Chief Executive Officer
of Relmada. The Company has a robust portfolio of patent applications covering the proprietary synthesis, the methods-of-use of psilocybin
to treat metabolic diseases, as well as patent applications covering the composition of matter of various formulations of psilocybin and
Presentation Details
Abstract Number: 2468-C, THE
SEROTONIN RECEPTOR AGONIST PSILOCYBIN AS A NOVEL THERAPEUTIC APPROACH FOR NAFLD: PRECLINICAL STUDIES.
Presentation Type: Abstract Poster
Presentation Date and Time: Saturday,
November 11, 2023, 8:00 AM
Presentation Location: Poster Hall
About Relmada Therapeutics, Inc.
Relmada Therapeutics is a late-stage biotechnology
company addressing diseases of the central nervous system (CNS), with a focus on major depressive disorder (MDD). Relmada's experienced
and dedicated team is committed to making a difference in the lives of patients and their families. Relmada's lead program, REL-1017,
is a new chemical entity (NCE) and novel NMDA receptor (NMDAR) channel blocker that preferentially targets hyperactive channels while
maintaining physiological glutamatergic neurotransmission. REL-1017 is in late-stage development as an adjunctive treatment for MDD in
adults. Learn more at www.relmada.com.
Forward-Looking Statements
The Private Securities Litigation Reform Act of
1995 provides a safe harbor for forward-looking statements made by us or on our behalf. This press release contains statements which constitute
"forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities
Exchange Act of 1934. Any statement that is not historical in nature is a forward-looking statement and may be identified by the use of
words and phrases such as "expects," "anticipates," "believes," "will," "will likely
result," "will continue," "plans to," "potential," "promising," and similar expressions.
These statements are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties
and assumptions that could cause actual results to differ materially from those described in the forward-looking statements, including
potential failure of clinical trial results to demonstrate statistically and/or clinically significant evidence of efficacy and/or safety,
failure of top-line results to accurately reflect the complete results of the trial, failure of the 310 open-label study to accurately
reflect the results of the ongoing 302 and 304 blinded, randomized and controlled studies, failure to obtain regulatory approval of REL-1017
for the treatment of major depressive disorder, failure of the psilocybin program to advance
to later stages of development, and the other risk factors described under the heading "Risk Factors" set forth in the Company's
reports filed with the SEC from time to time. No forward-looking statement can be guaranteed, and actual results may differ materially
from those projected. Relmada undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information,
future events, or otherwise. Readers are cautioned that it is not possible to predict or identify all the risks, uncertainties and other
factors that may affect future results and that the risks described herein should not be a complete list.
Corporate Communications