Silo Pharma, Inc. (Nasdaq: SILO) is making strides in its development programs for SPC-15, an intranasal treatment for post-traumatic stress disorder (PTSD), and SP-26, a ketamine implant for fibromyalgia and chronic pain. The company anticipates submitting an Investigational New Drug (IND) application for SPC-15 to the FDA in 2025, with Phase 1 clinical trials planned upon IND approval. Simultaneously, SP-26 is advancing towards animal testing, scheduled for early 2025.
SPC-15: Intranasal PTSD Treatment
SPC-15, Silo Pharma's lead program, is designed as a prophylactic treatment for PTSD and stress-induced anxiety disorders. The drug is a serotonin 5-HT4 receptor agonist delivered via an intranasal formulation. According to Silo Pharma, a pre-IND meeting was held with the FDA in September 2024 to align on the 505(b)(2) regulatory pathway for SPC-15, which could lead to a faster approval process.
Beyond PTSD and stress, preclinical data suggests SPC-15 may also be effective in treating eating disorders and anorexia. Furthermore, studies combining SPC-15 with an NMDA receptor (NMDAR) antagonist have shown enhanced efficacy in treating major depressive disorder (MDD) and other severe stress-related conditions.
Silo Pharma holds an exclusive global license from Columbia University to develop, manufacture, and commercialize SPC-15 worldwide.
SP-26: Ketamine-Loaded Implants for Chronic Pain
SP-26 is a novel ketamine implant designed for sustained relief of fibromyalgia and chronic pain. The subcutaneous implant is designed to regulate dosage and time release of ketamine, offering a potential alternative to opioid treatments. Animal testing is scheduled to begin in early 2025 to evaluate dosage, time release, and drug absorption.
Silo Pharma is also focusing on ensuring that the safety profile of SP-26 aligns with FDA requirements for potential at-home therapeutic designation. If approved, SP-26 could become the first at-home injectable ketamine-based therapeutic.
Streamlined Approval Pathways
Both SPC-15 and SP-26 are being developed with the intention of qualifying for the FDA’s 505(b)(2) regulatory pathway. This pathway allows drug developers to use publicly available data on active ingredients, potentially shortening clinical timelines and reducing development costs compared to a traditional New Drug Application (NDA).
Market Opportunity
Silo Pharma highlights the significant unmet need in the treatment of central nervous system (CNS) diseases, particularly PTSD, where there have been no new drug approvals in nearly 25 years, despite affecting an estimated 3.9% of the world’s population. The company also notes the large and growing markets for Alzheimer’s disease and multiple sclerosis, which are being addressed by their neurology programs SPC-14 and SPU-15, respectively. The Alzheimer’s disease treatment market is projected to reach $30.8 billion by 2033, with an 18.8% CAGR, while the global market for multiple sclerosis drugs is projected to grow to $38.9 billion by 2032, at a 7.9% CAGR.
With a solid balance sheet and minimal debt, Silo Pharma believes it is well-positioned to advance its pipeline of novel therapeutics.
