Silo Pharma Inc. (NASDAQ: SILO), a biopharmaceutical company in the developmental stage, has announced the imminent release of data from two pivotal preclinical studies for its lead candidate, SPC-15, a novel intranasal prophylactic aimed at enhancing stress resilience and preventing Post-Traumatic Stress Disorder (PTSD). The results, expected within the next 30 to 90 days, will come from IND-enabling GLP-compliant toxicology and toxicokinetic testing, alongside a large animal safety study mandated by the FDA. These findings are critical for the company's planned Investigational New Drug (IND) application, potentially submitted by the end of the year, with a Phase 1 clinical trial on the horizon for 2026.
The significance of SPC-15 lies in its potential to address a gap in PTSD treatment, a field that has not seen a new FDA drug approval in nearly a quarter of a century. Silo Pharma is leveraging the FDA's 505(b)(2) pathway to accelerate the development of SPC-15, highlighting the therapy's innovative approach to a condition that affects millions worldwide. The company's focus on underserved conditions, including stress-induced psychiatric disorders and chronic pain, positions SPC-15 as a beacon of hope for patients and a noteworthy development in the biopharmaceutical industry.
For further details on Silo Pharma's announcement, visit https://ibn.fm/6DnXK.
