Silo Pharma Begins SP-26 Study for Chronic Pain and Fibromyalgia

Silo Pharma, Inc., a company engaged in developing innovative pharmaceutical formulations, has announced the commencement of an important pharmacokinetic and tolerability study. This research is being conducted in collaboration with AmplifyBio, a contract research organization. The study aims to evaluate the pharmacokinetics of Silo's new ketamine-based injectable implant, SP-26, using a minipig model. SP-26 is an extended-release, non-opioid therapeutic designed for the treatment of chronic pain and fibromyalgia, which may be self-administered by patients.

The study will last for three weeks and is non-GLP compliant. It focuses on understanding the absorption, distribution, metabolism, and excretion (ADME) characteristics of the extended-release ketamine hydrochloride implants. Two different polymer formulations are being tested at various dosage levels to ascertain their effectiveness and safety.

Eric Weisblum, the CEO of Silo Pharma, expressed enthusiasm about the progress of SP-26. He mentioned that several studies have been conducted earlier this year, which included analytical testing, small batch proof-of-concept extrusion trials, manufacturing evaluations, and sterilization and dissolution tests. These studies have provided encouraging results, leading to the advancement into animal studies. Weisblum highlighted the significance of this development as a crucial step towards providing an innovative ketamine treatment for chronic pain sufferers.

Jerry Hacker, Executive Vice President and Chief Commercial Officer of AmplifyBio, stated that the organization is privileged to support Silo Pharma in achieving this critical safety milestone for SP-26. He emphasized their commitment to executing the pharmacokinetic study with efficiency and excellence.

SP-26 is an injectable, dissolvable polymer implant formulated with ketamine for the treatment of conditions such as chronic pain and fibromyalgia. This subcutaneous implant is intended to ensure safe dosage regulation and controlled release of the medication. If the clinical trials prove successful, SP-26 might qualify for the FDA’s expedited 505(b)(2) pathway for drug approval.

Silo Pharma, Inc., listed on Nasdaq as SILO, is a developmental stage biopharmaceutical company. It is focused on creating unique therapeutic solutions for conditions that are currently underserved, such as stress-related psychiatric disorders, chronic pain, and central nervous system diseases. The company explores both traditional and psychedelic treatments, developing them in novel formulations and delivery mechanisms.

Silo Pharma's leading program, SPC-15, is an intranasal therapy aimed at addressing PTSD and stress-induced anxiety. Another key program, SP-26, involves the development of a time-release ketamine implant for conditions like fibromyalgia and chronic pain. Additionally, Silo Pharma is pursuing two preclinical initiatives: SPC-14, an intranasal treatment targeting Alzheimer’s disease, and SPU-16, a peptide therapy for multiple sclerosis (MS) that focuses on the central nervous system.

The research and development initiatives at Silo Pharma are carried out in collaboration with universities and independent laboratories, aiming to translate innovative scientific discoveries into effective clinical solutions.