Silo Pharma Announces Successful Production of its SP-26 Ketamine Implant for Fibromyalgia
07 Giugno 2024 - 2:18PM
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 a
successful series of development activities for the Company’s SP-26
ketamine implant therapeutic targeting fibromyalgia and chronic
pain.
An ongoing pre-clinical research study of SP-26
is underway involving analytical testing services and small batch
proof-of-concept extrusion trials for the ketamine hydrochloride
(ketamine HCL) implants at 20% and 40% drug load.
The Company previously reported that the initial
testing provided validation of the delivery system based on
measures of structural stability and integrity at both load
levels. Following those tests, a series of manufacturing studies
were conducted using three different bioresorbable
polymers. The assay testing revealed positive data for
inherent viscosity (IV), blend uniformity (BU), and dissolution of
the implants:
- IV results were within the expected range for drug delivery of
the active ingredient, and higher for the combined formulation with
ketamine
- The sample results met FDA guidelines for an adequate level of
blending
- The larger implants showed faster dissolution time
Silo CEO, Eric Weisblum commented, “The results
so far in our ongoing SP-26 pre-clinical research bring us closer
to determining the optimal formulation for future pre-clinical
testing models. We are pleased with the structural stability,
integrity, and functionality observed to date for our innovative
non-opioid chronic pain therapeutic.”
About SP-26
Silo’s SP-26 is a ketamine-based injectable
dissolvable implant for the treatment of chronic pain and
fibromyalgia. The subcutaneous implant is being designed to safely
regulate dosage and time release of the pain-relieving treatment.
If clinically successful, SP-26 could qualify for the FDA’s
streamlined 505(b)(2) regulatory pathway for drug
approval.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.
Forward-Looking
Statements
This news release contains "forward-looking
statements" within the meaning of the “safe harbor” provisions of
the Private Securities Litigation Reform Act of 1995. These
statements are identified by the use of words “could”, “believe”,
“anticipate”, “intend”, “estimate”, “expect”, “may”, “continue”,
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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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