Silo Pharma, Inc. (NASDAQ: SILO), has announced promising results from a 7-day large-animal safety study assessing its intranasal spray formulation of SPC-15, aimed at treating post-traumatic stress disorder (PTSD).
- The FDA-requested preclinical trial showed no safety concerns, with no signs of local or systemic toxicity.
- Importantly, the intranasal delivery achieved exposure levels comparable to those of the oral version of SPC‑15, offering a potentially faster and more patient-friendly treatment route.
CEO Eric Weisblum highlighted that the successful nasal formulation meets safety benchmarks for clinical testing, promising a “safe, easily administered, and fast-acting” alternative to oral therapy.
The data sets the stage for advancing SPC‑15 through the FDA’s 505(b)(2) regulatory pathway, which can leverage established safety profiles to expedite drug approval and reduce development expenses.
Silo is now conducting GLP-compliant toxicology and toxicokinetic studies, along with evaluating device compatibility for its microchip-based nasal spray delivery system. Clinical trial sites are also being evaluated for upcoming first-in-human testing.
With the PTSD treatment market estimated at $1.8 billion in 2024 and projected to expand to $3.2 billion by 2034, this milestone positions SPC‑15 favorably to address growing demand for innovative mental health therapies.
The post Silo Pharma’s Intranasal PTSD Therapy SPC-15 Clears Key Safety Milestone, Eyeing Accelerated Clinical Trial Path appeared first on PRISM MarketView.
