Silo Pharma Anticipates Key Data for PTSD Treatment SPC-15

Silo Pharma (NASDAQ: SILO), a developmental-stage biopharmaceutical company, is on the verge of receiving pivotal data from two preclinical studies of its lead candidate, SPC-15, a novel intranasal prophylactic aimed at enhancing stress resilience and preventing Post-Traumatic Stress Disorder (PTSD). The data, 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 results are critical for Silo Pharma's planned Investigational New Drug (IND) application, which could be submitted before the end of the year, paving the way for a Phase 1 clinical trial by 2026.

The company is leveraging the FDA's 505(b)(2) regulatory pathway to accelerate the development of SPC-15, a strategic move that could significantly shorten the timeline to market for this promising therapy. This approach is particularly noteworthy in the PTSD treatment landscape, which has not seen a new FDA-approved drug in nearly a quarter of a century. The potential success of SPC-15 could herald a new era of treatment options for individuals suffering from PTSD and stress-induced anxiety disorders, addressing a critical unmet need in mental health care.

Beyond SPC-15, Silo Pharma is also developing other innovative therapies, including SP-26, a time-release, ketamine-loaded implant for fibromyalgia and chronic pain relief, and preclinical programs targeting Alzheimer’s disease and multiple sclerosis. These efforts underscore the company's commitment to advancing novel treatments for underserved conditions through collaborations with universities and independent laboratories.

The upcoming data release for SPC-15 represents a significant milestone not only for Silo Pharma but also for the broader psychiatric and pharmaceutical communities. A successful outcome could validate the company's innovative approach to drug development and open new avenues for treating PTSD and related disorders. For more information on Silo Pharma's groundbreaking work, visit https://www.SiloPharma.com.