Silo Pharma to receive SPC-15 data within 30-90 days, IND application planned for 2025.

Silo Pharma expects to receive data from preclinical studies of its lead asset SPC-15 within the next 30-90 days. SPC-15 is a novel intranasal prophylactic targeting Post-Traumatic Stress Disorder (PTSD). The company plans to submit an IND application in 2025 and begin a Phase 1 clinical trial if the application is approved. No new PTSD drug approvals have been made in the U.S. in nearly 25 years, making SPC-15 a potential solution for a large addressable market worldwide.

Silo Pharma (Nasdaq: SILO) has made significant progress in the development of SPC-15, its novel intranasal PTSD drug candidate. The company expects to receive crucial preclinical study data within the next 30-90 days, including results from GLP-compliant toxicology studies and an FDA-requested safety study. This data is essential for Silo Pharma's planned IND (Investigational New Drug) application by the end of 2025, which could potentially lead to Phase 1 clinical trials in 2026 [1].

SPC-15's unique approach targets stress resilience, differentiating it from existing PTSD treatments. The market for PTSD treatment is substantial, with approximately 3.9% of the global population affected by the condition. If Silo Pharma's timeline holds, they could begin Phase 1 trials by late 2026. However, investors should recognize that many developmental-stage compounds fail during the IND-enabling or clinical trial phases [2].

Silo Pharma's strategic approach to regulatory approval includes pursuing the FDA's 505(b)(2) pathway, which allows companies to rely partly on previously established safety and efficacy data. This regulatory route can significantly reduce development time and costs. The PTSD treatment landscape has remained stagnant for nearly 25 years, with only two FDA-approved medications, both primarily targeting depression symptoms rather than the core PTSD pathology [1].

The market opportunity for PTSD treatment is substantial, with approximately 3.9% of the global population affected by the condition. Silo Pharma's SPC-15, if successful, could offer improved therapeutic delivery through its intranasal delivery system using microchip technology. The company's progress in developing SPC-15 represents a significant milestone in their PTSD treatment development program [1].

References:
[1] https://www.stocktitan.net/news/SILO/silo-pharma-advances-ptsd-drug-spc-15-toward-planned-2025-ind-snbhxugmpe5i.html
[2] https://www.theglobeandmail.com/investing/markets/markets-news/GetNews/33130941/posttraumatic-stress-disorder-pipeline-appears-robust-with-20-key-pharma-companies-actively-working-in-the-therapeutics-segment-delveinsight