Silo Pharma Completes FDA Pre-IND Meeting for Intranasal PTSD Treatment SPC-15
Key Insights
Silo Pharma (search) completed a pre-IND meeting with the FDA for SPC-15, an intranasal prophylactic treatment for PTSD (search) and stress-induced anxiety disorders.
The meeting focused on aligning with the FDA on the 505(b)(2) regulatory pathway for SPC-15 approval, potentially shortening clinical timelines and reducing costs.
SPC-15 is a novel serotonin 4 (5-HT4) receptor agonist being developed as an intranasal medication for PTSD (search), anxiety, and other stress-induced affective disorders.
Silo Pharma (search), Inc. (Nasdaq: SILO) has announced the successful completion of a pre-Investigational New Drug (pre-IND) meeting with the U.S. Food and Drug Administration (FDA) regarding its development plan for SPC-15, an intranasal prophylactic treatment for post-traumatic stress disorder (PTSD (search)) and stress-induced anxiety disorder (search). The FDA's Division of Regulatory Operations for Neuroscience (DRON) - Psychiatry Group provided written responses during the meeting.
The primary objective of the pre-IND meeting was to align with the FDA on the 505(b)(2) regulatory pathway for SPC-15 approval and to discuss Silo Pharma (search)'s proposed plan to support the opening of an IND. The 505(b)(2) pathway is anticipated to significantly shorten clinical timelines and reduce drug development costs.
Advancing SPC-15 Towards Clinical Trials
According to Silo CEO Eric Weisblum, the FDA provided valuable feedback on the SPC-15 development plan. "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 (search) treatment market," Weisblum stated.
Silo Pharma (search) is currently conducting a GLP-compliant pharmacokinetic and pharmacodynamic study in preparation for an IND submission for a potential first-in-human (FIH) clinical trial of SPC-15. Pre-clinical data suggests that SPC-15's optimized patient safety and therapeutic delivery offer additive benefits for combating stress-induced pathophysiology at both behavioral and neural levels. Columbia University has granted Silo Pharma an exclusive license to further develop, manufacture, and commercialize SPC-15 worldwide.
About SPC-15
SPC-15 is a novel serotonin 4 (5-HT4) receptor agonist that utilizes biomarkers for the treatment of PTSD (search), anxiety, and other stress-induced affective disorders. It is being developed as an intranasal medication and, if clinically successful, could qualify for the FDA’s streamlined 505(b)(2) regulatory pathway for drug approval. Silo Pharma (search) is conducting preclinical studies of SPC-15 in collaboration with Columbia University and holds an exclusive license for its development and commercialization.
Silo Pharma's Broader Pipeline
Silo Pharma (search) Inc. (Nasdaq: SILO) is focused on developing novel therapeutics for underserved conditions, including stress-induced psychiatric disorders, chronic pain conditions, and central nervous system (CNS) diseases. The company's pipeline includes SP-26, a time-release ketamine-loaded implant for fibromyalgia (search) and chronic pain relief, SPC-14, an intranasal compound for Alzheimer’s disease (search), and SPU-16, a CNS-homing peptide targeting multiple sclerosis (search) (MS).