Silo Pharma completes pre-IND meeting with FDA regarding SPC-15

Silo Pharma announced the completion of a pre-Investigational New Drug meeting with the U.S. FDA regarding the company’s development plan for SPC-15, an intranasal prophylactic treatment for post-traumatic stress disorder and stress-induced anxiety disorder. The pre-IND meeting was completed through written responses provided by the FDA’s Division of Regulatory Operations for Neuroscience – Psychiatry Group. The primary purpose of the pre-IND meeting was to align with the FDA on the 505(b)(2) regulatory pathway for approval of SPC-15 along with Silo‘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. Silo is currently conducting a GLP-compliant pharmacokinetic and pharmacodynamic study in advance of an IND submission for a potential first-in-human clinical trial of SPC-15. Pre-clinical data to date indicate that SPC-15’s optimized patient safety and therapeutic delivery has additive benefits for combating stress-induced pathophysiology, both at the behavioral and neural levels. Columbia University has granted Silo an exclusive license to further develop, manufacture, and commercialize SPC-15 worldwide.