Silo Pharma, Inc. announced first dosing in an investigational new drug (IND)-enabling GLP (Good Laboratory Practice)-compliant toxicology and toxicokinetics study of its lead asset, SPC-15, an intranasal prophylactic treatment for post-traumatic stress disorder (PTSD).
“This IND-enabling safety study and our concurrent GLP-compliant pharmacokinetic and pharmacodynamic study, if successful, will provide the last preclinical data needed to open an IND for SPC-15,” said Eric Weisblum, CEO of Silo. “We are following the FDA’s helpful responses to our pre-IND submission, which provide a clear path to an IND submission to first-in-human clinical studies.”
Silo Pharma completed a pre-IND meeting in September 2024 to align with the FDA on the 505(b)(2) regulatory pathway for approval of SPC-15 and review the Company’s proposed plan to support opening an IND. The FDA’s 505(b)(2) drug development route can significantly shorten clinical timelines for FDA approval and reduce drug development costs.
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