SARASOTA, FL - Silo Pharma, Inc. (NASDAQ:SILO), a biopharmaceutical company, has announced the successful completion of a dose-ranging study for its PTSD and anxiety intranasal treatment, SPC-15, setting the stage for clinical trials. The study aimed to establish the maximum tolerated dose for small animals and determine the appropriate dose range for future human clinical evaluations.
The non-GLP (Good Laboratory Practice) small animal study found that SPC-15 was rapidly absorbed and maintained good exposure levels over 24 hours, indicating a once-per-day dosing regimen could be effective in humans. Silo Pharma's CEO, Eric Weisblum, stated that the company is on track to submit a pre-investigational New Drug Application (IND) to the FDA by the end of the second quarter of 2024.
SPC-15, a novel serotonin 4 (5-HT4) receptor agonist, is being developed as an intranasal medication for the treatment of PTSD, anxiety, and other stress-related disorders. If successful in clinical trials, SPC-15 could benefit from the FDA's 505(b)(2) regulatory pathway, which may streamline the drug approval process.
Silo Pharma is engaged in preclinical studies of SPC-15 in partnership with Columbia University. In addition to SPC-15, Silo's portfolio includes SP-26, a time-release ketamine implant for chronic pain and fibromyalgia, and other preclinical programs targeting central nervous system diseases like Alzheimer's and multiple sclerosis.
The company's research and development efforts are supported by collaborations with academic institutions, including Columbia University and the University of Maryland, Baltimore.
This news is based on a press release statement from Silo Pharma, Inc. The company cautions that the forward-looking statements contained in the release are subject to risks and uncertainties that could cause actual results to differ materially from those anticipated.
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