Silo Pharma Initiates Pharmacokinetic and Tolerability Study for SP-26 Targeting Chronic Pain and Fibromyalgia

Rhea-AI Summary

Silo Pharma (NASDAQ: SILO) has initiated a pharmacokinetic (PK) and tolerability study for SP-26, its dissolvable ketamine-based injectable implant targeting chronic pain and fibromyalgia. The three-week non-GLP study, conducted in partnership with AmplifyBio, will evaluate the absorption, distribution, metabolism, and excretion of extended-release ketamine hydrochloride implants in a minipig model. Two different polymer formulations will be tested at various dose levels.

This milestone follows several previous studies including analytical testing, proof-of-concept extrusion trials, manufacturing evaluation, and sterilization tests. SP-26 is being developed as a self-administered, non-opioid therapeutic and aims to be a first-of-its-kind ketamine treatment for chronic pain.

Positive

• Advancement to animal studies phase represents significant milestone in drug development
• SP-26 potentially represents first-of-its-kind ketamine treatment for chronic pain
• Previous studies showed encouraging results in analytical testing and proof-of-concept trials

Negative

• Study is non-GLP, indicating early stage of development
• No efficacy data available yet

Key preclinical milestone for novel, non-opioid extended-release pain therapeutic  

SARASOTA, FL, Dec. 18, 2024 (GLOBE NEWSWIRE) -- 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 .

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”, “predict”, “potential”, and similar expressions that are intended to identify forward-looking statements. Such statements involve known and unknown risks, uncertainties, and other factors that 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 news release, whether as a result of new information, future events, or otherwise, after the date of this news release or to reflect the occurrence of unanticipated events except as required by law.

Contact 

800-705-0120 
investors@silopharma.com

FAQ

What is the purpose of Silo Pharma's SP-26 pharmacokinetic study announced in December 2023?

The study aims to assess the pharmacokinetics of Silo's dissolvable ketamine-based injectable implant (SP-26) in a minipig model, evaluating absorption, distribution, metabolism, and excretion of the drug.

How long will SILO's SP-26 pharmacokinetic study last?

The non-GLP study is set to span three weeks.

What medical conditions is Silo Pharma's SP-26 targeting?

SP-26 is being developed to treat chronic pain and fibromyalgia as a self-administered, non-opioid therapeutic.

What previous studies has SILO conducted for SP-26?

SILO has conducted analytical testing, small batch proof-of-concept extrusion trials, manufacturing and production evaluation, and sterilization and dissolution tests.

Who is SILO's research partner for the SP-26 pharmacokinetic study?

Silo Pharma is conducting the study in partnership with AmplifyBio, their contract research organization (CRO).