Silo Pharma Completes Successful Dose-Ranging Study of SPC-15 Intranasal Therapeutic for PTSD
Silo Pharma, Inc. recently announced positive results from its non-GLP small animal dose-ranging study of SPC-15, an intranasal prophylactic treatment for anxiety and post-traumatic stress disorder (PTSD).
The purpose of the non-GLP small animal study was to identify the maximum tolerated intranasal dose of the drug pharmacokinetic and determine the therapeutically relevant dose range to be studied in clinical trials. Data analysis demonstrated rapid absorption of SPC-15 with good exposure over a 24-hour period, suggesting a once-per-day human intranasal dosing regimen would be optimal.
“Non-GLP and GLP toxicology and safety pharmacology studies are required steps before seeking approval for our first-in-human clinical-stage trials of SPC-15,” said Eric Weisblum, CEO of Silo. “We are currently on track to submit a pre-investigational New Drug Application (IND) to the FDA by the end of the second quarter 2024. This is an exciting step forward for our Company as we advance our lead therapeutic, SPC-15.”
SPC-15 is a novel serotonin 4 (5-HT4) receptor agonist that utilizes biomarkers for the treatment of PTSD, anxiety, and other stress-induced affective disorders. SPC-15 is being developed as an intranasal medication. If clinically successful, SPC-15 could qualify for the FDA’s streamlined 505(b)(2) regulatory pathway for drug approval. Silo Pharma is conducting preclinical studies of SPC-15 in collaboration with Columbia University under a sponsored research agreement and option.
Silo Pharma Inc. (Nasdaq: SILO) is a developmental stage biopharmaceutical company developing novel therapeutics that address underserved conditions including stress-induced psychiatric disorders, chronic pain conditions, and central nervous system (CNS) diseases. Silo focuses on developing traditional therapies and psychedelic treatments in novel formulations and drug delivery systems. The company’s lead program, SPC-15, is an intranasal treatment targeting PTSD and stress-induced anxiety disorders. SP-26 is a time-release ketamine-loaded implant for fibromyalgia and chronic pain relief. Silo’s two preclinical programs are SPC-14, an intranasal compound for the treatment of Alzheimer’s disease, and SPU-16, a CNS-homing peptide targeting multiple sclerosis (MS). Silo’s research and development programs are conducted through collaborations with Columbia University and the University of Maryland, Baltimore. For more information, visit www.silopharma.com.
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