Silo Pharma completes first phase of dose-ranging study of SPC-15

Silo Pharma provided an update on its previously announced dose-ranging study of SPC-15, a targeted prophylactic treatment for post-traumatic stress disorder. The purpose of the study is to identify the maximum tolerated intranasal dose of the drug and pharmacokinetic in small animals to determine the therapeutically relevant dose range with the goal of bringing us closer to human trials. The six- to eight-week non-GLP study includes single ascending dose evaluation and a 7-day repeat intranasal dose toxicity and pharmacokinetic study. In the first phase of the study, all of the animals appeared to tolerate the intranasal dosing procedure well, with minimal struggling and no sneezing observed. The final validation report is expected in the first quarter of 2024. Pre-clinical data has shown that SPC-15 has additive benefits for combating stress-induced pathophysiology, both at the behavioral and neural levels. Pre-clinical collaborative work with Columbia University will be coupled with published preclinical data in a pre-IND application to the FDA, which the Company expects to submit during the first quarter of 2024.