Silo Pharma Inc. (NASDAQ: SILO), a biopharmaceutical company in the developmental stage, has announced that it expects to receive data from two critical preclinical studies of its leading candidate, SPC-15, within the next 30 to 90 days. This intranasal prophylactic is designed to enhance stress resilience and prevent the onset of Post-Traumatic Stress Disorder (PTSD), a condition that has seen no new FDA drug approvals in nearly a quarter of a century.
The studies currently underway include IND-enabling GLP-compliant toxicology and toxicokinetic testing, alongside a large animal safety study requested by the FDA. The outcomes of these studies are crucial as they will inform the planned Investigational New Drug (IND) application, which Silo Pharma aims to submit potentially before the end of the year. Following this, a Phase 1 clinical trial is anticipated to commence in 2026.
Silo Pharma is pursuing the FDA's 505(b)(2) regulatory pathway for SPC-15, a strategy that could significantly expedite the development process of this innovative therapy. This approach is particularly noteworthy given the lack of new treatments for PTSD over the past 25 years, highlighting the potential impact of SPC-15 on patients and the broader medical community.
The development of SPC-15 represents a novel approach to treating PTSD and stress-induced anxiety disorders, offering hope to millions of individuals affected by these conditions worldwide. The upcoming study results could mark a significant milestone in mental health treatment, providing a much-needed alternative to existing therapies.
For more information on Silo Pharma's groundbreaking work and its potential to revolutionize PTSD treatment, visit https://ibn.fm/6DnXK.
