SARASOTA, FL, April 23, 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 positive data in the final validation report from the recent pharmacokinetic (PK) study
of SPC-15, an intranasal prophylactic treatment for anxiety and post-traumatic stress disorder (PTSD). The PK study was conducted as part of non-GLP small animal dose-ranging study of SPC-15 completed in February 2024.
The activity of SPC-15 in the subjects or the PK study was evaluated over a 7-day repeat intranasal dose, including the processes of absorption, distribution, and excretion. Time to peak drug concentration (Tmax) occurred between 0.5 and 2 hours following intranasal administration compared to 2 hours following oral gavage administration. In previous findings from the non-GLP study, SPC-15 demonstrated rapid absorption with good exposure over a full 24-hour period, and based on these studies we determined an optimal once-per-day human intranasal dosing.
Silo CEO Eric Weisblum commented, “Our evaluation of the PK profile for SPC-15 indicates effective and consistent exposure from intranasal administration of the drug. We believe these study results will be substantially replicated in humans.”
Now completed, the non-GLP study will be followed by a progressive intellectual and neurological deterioration (PIND) study and then a GLP study, both slated to commence in 2024, and both of which are additional required steps before submission of an Investigational New Drug (IND) application for SPC-15 to the FDA.
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 and connect on social media at LinkedIn, X, and Facebook.