Silo Pharma Initiates Pharmacokinetic and Tolerability Study for SP-26 Targeting Chronic Pain and Fibromyalgia
18 Diciembre 2024 - 6:35AM
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 the
initiation of a pharmacokinetic (PK) and tolerability study in
partnership with its contract research organization (CRO),
AmplifyBio. The study is designed to assess the pharmacokinetics of
Silo’s dissolvable ketamine-based injectable implant, SP-26, in a
minipig model. SP-26 is being developed as a self-administered,
non-opioid therapeutic aimed at treating chronic pain and
fibromyalgia.
The non-GLP study, set to span three weeks, will investigate the
absorption, distribution, metabolism, and excretion (ADME) of
extended-release ketamine hydrochloride implants. Two distinct
polymer formulations will be tested at varying dose levels.
“So far this year we have conducted several studies of our SP-26
ketamine implants including analytical testing and small batch
proof-of-concept extrusion trials, manufacturing and production
evaluation, and sterilization and dissolution tests, with what we
believe are encouraging results,” said Silo CEO Eric Weisblum. “The
advancement of this program into animal studies is an important
milestone achievement as we work to bring a safe and effective and
to our knowledge, first-of-its-kind ketamine treatment for those
living with chronic pain.”
“AmplifyBio is honored to support Silo Pharma in this critical
safety milestone for SP-26. We understand and take seriously the
trust put in us to execute the PK study efficiently and with
excellence,” said Jerry Hacker, EVP, and Chief Commercial Officer
for AmplifyBio.
About SP-26
SP-26 is a ketamine-based injectable dissolvable polymer 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 universities and independent
laboratories. For more information,
visit www.silopharma.com and connect on social media
at LinkedIn , X , and Facebook .
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