US-based Silo Pharma has partnered with North Carolina-based Kymanox to jointly design and develop a subcutaneous insertion device for SP-26, the former’s ketamine-loaded implant therapeutic.
As part of the agreement, Kymanox will conduct an initial proof-of-concept design phase followed by a full system prototype and feasibility testing to determine optimal insertion depth in tissue. Silo Pharma intends to develop the SP-26 implant as the “first at-home injectable ketamine-based therapeutic”.
Following the announcement, Silo Pharma’s stock was up by 12.35% at the market close on Friday (29 November), compared to market close on the previous working day (27 November).
SP-26 is a ketamine-based injectable dissolvable polymer implant being developed as a treatment for chronic pain and fibromyalgia. The implant is designed to regulate the dosage and time of release of the ketamine treatment.
Silo Pharma noted that, if clinically successful, SP-26 could qualify for the US Food and Drug Administration (FDA)’s streamlined 505(b)(2) regulatory pathway for drug approval. The pathway is designed for faster approval of “modified versions of approved drugs, new combinations, or new indications” for “lower risk, reduced costs, faster development and potential market exclusivity”.
“Previous analytical testing and proof-of-concept extrusion trials have confirmed the optimal formulation for our SP-26 implants. Now we are advancing this program to develop a novel insertion device that is intended to be tested in continuing preclinical studies,” said Eric Weisblum, Silo Pharma’s CEO.
A US Centers for Disease Control and Prevention (CDC) study estimated that approximately 51.6 million people in the US experienced chronic pain, with 17.1 million experiencing chronic pain that results in substantial restrictions to daily activities.
Multiple medical device manufacturers are developing pain management devices. In January, Boston Scientific reported positive one-year data for its WaveWriter Alpha spinal cord stimulation (SCS) system. The SOLIS trial results showed that the SCS device can reduce pain in chronic pain patients by 50%, with 85% of patients who declared a drop in pain reporting a greater ability to take part in daily activities.
Silo’s lead programme is SPC-15, an intranasal treatment targeting post-traumatic stress disorder (PTSD) and stress-induced anxiety disorders. Kymanox also serves as the company's regulatory partner for this project. Silo’s preclinical pipeline consists of SPC-14, an intranasal compound for the treatment of Alzheimer’s disease, and SPU-16, a CNS-homing peptide targeting multiple sclerosis.
