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Silo Pharma Announces Completion of FDA Pre-IND Meeting to Advance Development of SPC-15 for Treatment of PTSD
Proposal submitted for FDA 505(b)(2) regulatory pathway for SPC-15 approval Advancing...
About this update from Silo Wellness Inc
[{"type":"text","content":"Silo Pharma Announces Completion of FDA Pre-IND Meeting to Advance Development of SPC-15 for Treatment of PTSD\n\n\n\n\n\n Proposal submitted for FDA 505(b)(2) regulatory pathway for SPC-15 approval\n \n\n\n\n\n\n Advancing path to IND submission for first-in-human trials\n \n\n\n\n SARASOTA, FL, Sept. 10, 2024 (GLOBE NEWSWIRE) -- Silo Pharma, Inc. (Nasdaq: SILO) (“Silo” or the “Company”), a developmental stage biopharmaceutical company focused on developing novel formulations and drug delivery systems for traditional therapeutics and psychedelic treatments, today announced the completion of a pre-Investigational New Drug (pre-IND) meeting with the U.S. Food and Drug Administration (FDA) regarding the Company's development plan for SPC-15, an intranasal prophylactic treatment for post-traumatic stress disorder (PTSD) 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 (DRON) - Psychiatry Group.\n \n\n 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.\n \n\n “The FDA provided helpful written responses on our development plan for SPC-15,\" said Silo CEO Eric Weisblum. “We now have a clear path for advancing our development of SPC-15 into the clinic for in-human trials which will hopefully lead to FDA approval and ultimately allow us to commercialize our patented, cutting-edge intranasal treatment, to the PTSD treatment market.”\n \n\n Silo is currently conducting a GLP-compliant pharmacokinetic and pharmacodynamic study in advance of an IND submission for a potential first-in-human (FIH) 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.\n \n\n\n About SPC-1...