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

Silo Pharma, Inc. recently 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.

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.

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.