Thursday, Silo Pharma Inc
In November, Silo Pharma announced a new exclusive license agreement with Medspray Pharma BV for its proprietary patented soft mist nasal spray technology, the delivery mechanism selected for Silo's intranasal therapeutic drug SPC-15.
The study aims to identify the maximum tolerated intranasal dose of the drug and pharmacokinetic in small animals to determine the therapeutically relevant dose range.
The six-to eight-week non-GLP study includes a single ascending dose evaluation (phase 1) 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.
Eric Weisblum, Chief Executive Officer of Silo Pharma, commented, "There have been no adverse clinical observations reported to date for this study, which began in late November 2023 and will conclude in the first quarter of 2024. If successful, this non-GLP study will be followed by a GLP safety and toxicology study, both of which will be utilized in connection with filing an expected Investigational New Drug (IND) application with the FDA."
Preclinical data has shown that SPC-15 has additive benefits for combating stress-induced pathophysiology at the behavioral and neural levels.
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