Silo Pharma (SILO) announced positive bioanalytical and safety/toxicology results for its U.S. Food and Drug Administration, FDA-requested 7-day large animal safety study of its lead asset SPC-15. The preclinical study compared the safety and overall exposure of the SPC-15 intranasal spray formulation to oral drug administration. Data showed that SPC-15, administered at clinical-representative doses, demonstrated local and systemic safety with no toxicities identified. The study also showed that systemic exposure of intranasal SPC-15 administered at the anticipated therapeutic range is comparable to standard oral administration, which we believe validates the drug’s potential as a targeted intranasal therapeutic for PTSD and stress-induced anxiety that has a potentially greater safety profile.
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