USFDAJun 23, 2026, 08:18 AM
Silo Pharma Confirms SPC-15 Stability for FDA IND Program
AI Summary
Silo Pharma, a developmental-stage biopharmaceutical company, announced positive stability data for its investigational soft-mist intranasal prophylactic, SPC-15. The data confirmed the physical, chemical, and microbiological integrity of SPC-15's formulation over nine months of real-time testing and six months under accelerated conditions. This milestone supports the continued advancement of the company's FDA Investigational New Drug (IND)-enabling development program and validates adherence to cGMP standards, moving SPC-15 closer to a Phase 1 clinical study for stress-induced psychiatric conditions like PTSD and anxiety.
Key Highlights
- Silo Pharma confirmed physical, chemical, and microbiological stability of SPC-15 through nine months of real-time testing.
- Stability data supports continued advancement of the FDA Investigational New Drug (IND)-enabling development program.
- SPC-15's formulation and device remained within predefined specifications for assay, impurities, pH, and microbiological quality.
- The stability program was conducted under long-term and accelerated storage conditions aligned with IND-enabling CMC documentation.
- The data validates adherence to current Good Manufacturing Practice (cGMP) standards.
- SPC-15 is an investigational intranasal 5-HT4 receptor agonist for stress-induced psychiatric conditions like PTSD and anxiety.
- The company aims for an accelerated FDA approval pathway (505(b)(2)) for SPC-15.
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