Silo Pharma and Resyca BV Partner on Device and CMC Development for Intranasal PTSD Drug SPC-15
July 18 2024 - 8:25AM
Silo Pharma, Inc. (Nasdaq: SILO) (“Silo” or the “Company”), a
developmental stage biopharmaceutical company focused on developing
novel formulations and drug delivery systems for traditional
therapeutics and psychedelic treatments, today announced it has
entered into a Device and CMC Development Master Plan with Resyca
BV, a medical technology provider. Resyca is a joint venture
between Bespak Group and Medspray Pharma BV which manufactures the
formulation-specific microchip-based spray system chosen by Silo
for its lead candidate SPC-15, an intranasal prophylactic treatment
for post-traumatic stress disorder (PTSD).
“The patented nasal spray system uses
cutting-edge nose-to-brain drug dispersion, a delivery method that
transports the molecules to the brain directly, bypassing the
blood-brain barrier,” said Eric Weisblum, Chief Executive Officer
of Silo Pharma. “For SPC-15, we believe this delivery method could
increase the drug’s concentration in the brain to deliver a faster
onset of therapeutic benefit and optimized safety for PTSD
patients.”
This Device and CMC Development Master Plan is
intended to support the development, clinical formulation, and
stability of a previously announced investigational new drug
(IND)-enabling, large animal GLP (Good Laboratory Practice) study
of SPC-15. As part of an existing exclusive license agreement with
Medspray Pharma BV, one of joint venture members of Resyca BV, Silo
holds exclusive rights to Medspray’s spray mist technology for use
with multiple indications including PTSD.
Silo is currently conducting a GLP-compliant
pharmacokinetic and pharmacodynamic studies and recently submitted
a pre-IND briefing package and meeting request to the U.S. Food and
Drug Administration (FDA) for SPC-15. The studies are the final
steps required before submission of an IND application to the FDA
with the goal of starting its first in human clinical trial.
About SPC-15
SPC-15 is a novel serotonin 4 (5-HT4) receptor
agonist that utilizes biomarkers for the treatment of PTSD,
anxiety, and other stress-induced affective disorders. SPC-15
is being developed as an intranasal medication. If clinically
successful, SPC-15 could qualify for the FDA’s streamlined
505(b)(2) regulatory pathway for drug approval. Silo Pharma is
conducting preclinical studies of SPC-15 in collaboration with
Columbia University and was granted an exclusive license to further
develop, manufacture, and commercialize SPC-15 worldwide.
About Silo Pharma
Silo Pharma Inc. (Nasdaq: SILO) is a
developmental stage biopharmaceutical company developing novel
therapeutics that address underserved conditions including
stress-induced psychiatric disorders, chronic pain conditions, and
central nervous system (CNS) diseases. Silo focuses on developing
traditional therapies and psychedelic treatments in novel
formulations and drug delivery systems. The Company’s lead program,
SPC-15, is an intranasal treatment targeting PTSD and
stress-induced anxiety disorders. SP-26 is a time-release
ketamine-loaded implant for fibromyalgia and chronic pain relief.
Silo’s two preclinical programs are SPC-14, an intranasal compound
for the treatment of Alzheimer’s disease, and SPU-16, a CNS-homing
peptide targeting multiple sclerosis (MS). Silo’s research and
development programs are conducted through collaborations with
Columbia University and the University of Maryland, Baltimore. For
more information, visit www.silopharma.com and connect on social
media at LinkedIn, X, and Facebook.
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statements" within the meaning of the “safe harbor” provisions of
the Private Securities Litigation Reform Act of 1995. These
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could cause the actual results of Silo Pharma, Inc. (“Silo” or “the
Company”) to differ materially from the results expressed or
implied by such statements, including changes to anticipated
sources of revenues, future economic and competitive conditions,
difficulties in developing the Company’s technology platforms,
retaining and expanding the Company’s customer base, fluctuations
in consumer spending on the Company’s products and other factors.
Accordingly, although the Company believes that the expectations
reflected in such forward-looking statements are reasonable, there
can be no assurance that such expectations will prove to be
correct. The Company disclaims any obligations to publicly update
or release any revisions to the forward-looking information
contained in this presentation, whether as a result of new
information, future events, or otherwise, after the date of this
presentation or to reflect the occurrence of unanticipated events
except as required by law.
Contact 800-705-0120 investors@silopharma.com
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