Silo Pharma, Inc. 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 determined an optimal once-per-day human intranasal dosing. 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.