SARASOTA, FL - Silo Pharma, Inc. (NASDAQ:SILO), a biopharmaceutical company, has announced positive findings from a pharmacokinetic study of SPC-15, its intranasal treatment for anxiety and post-traumatic stress disorder (PTSD).
The study, part of a non-GLP small animal dose-ranging study completed in February 2024, showed rapid drug absorption and consistent exposure over a 24-hour period.
The study evaluated the absorption, distribution, and excretion of SPC-15 over a 7-day period, with peak drug concentrations occurring between 0.5 and 2 hours after intranasal administration, in contrast to 2 hours following oral administration. These results have led to the determination of an optimal once-per-day human dosing regimen for the intranasal application.
Eric Weisblum, CEO of Silo Pharma, stated, "Our evaluation of the PK profile for SPC-15 indicates effective and consistent exposure from intranasal administration of the drug." He expressed belief in the replication of these results in human studies.
Following the non-GLP study, Silo Pharma plans to conduct a progressive intellectual and neurological deterioration (PIND) study and a GLP study later in 2024, which are prerequisites for submitting an Investigational New Drug (IND) application for SPC-15 to the FDA.
SPC-15, a novel serotonin 4 (5-HT4) receptor agonist, is being developed to treat PTSD, anxiety, and other stress-induced affective disorders. If successful in clinical trials, the drug could be eligible for the FDA's 505(b)(2) regulatory pathway, which could streamline its approval process.
Silo Pharma is engaged in preclinical studies for SPC-15 in collaboration with Columbia University. The company is also developing other treatments for central nervous system diseases and chronic pain conditions.
The information in this article is based on a press release statement from Silo Pharma.
InvestingPro Insights
Silo Pharma's recent pharmacokinetic study results have generated a positive buzz around its intranasal treatment, SPC-15. As the company progresses with its research, investors and stakeholders are keenly observing its financial health and market performance.
According to real-time data from InvestingPro, Silo Pharma's market capitalization stands at a modest $5.62 million, reflecting its status as a niche player in the biopharmaceutical industry.
The company's gross profit margin is impressive at 91.9% for the last twelve months as of Q4 2023, indicating a strong ability to control costs relative to its revenue, which is particularly relevant for a company in the capital-intensive biotech sector.
Despite the challenges of profitability, with analysts not expecting the company to be profitable this year, Silo Pharma's share price has seen a significant uptick, with a 42.14% return over the last three months and a 46.32% increase over the last six months.
InvestingPro Tips highlight that Silo Pharma has been aggressively buying back shares and holds more cash than debt on its balance sheet, which could be a sign of management's confidence in the company's future. Moreover, with liquid assets exceeding short-term obligations, the company appears to be in a solid position to manage its liabilities and invest in its drug development pipeline.
For investors interested in a deeper dive into Silo Pharma's financials and market potential, there are additional InvestingPro Tips available that can provide further insights into the company's performance and outlook. Use the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription for more in-depth analysis and tips.
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