SARASOTA, FL - Silo Pharma Inc. (NASDAQ:SILO), a biopharmaceutical company, has initiated a pivotal Good Laboratory Practice (GLP) study for its SPC-15 intranasal therapeutic, marking progress towards human clinical trials. The GLP study, conducted by contract research organization AmplifyBio, is a key step in the development of SPC-15, a prophylactic treatment for post-traumatic stress disorder (PTSD).
The study will evaluate the effects of SPC-15 over a four-week period, including a 28-day repeat dosing and a 14-day recovery phase. This follows a non-GLP small animal study which showed that SPC-15 was rapidly absorbed and maintained good exposure levels over 24 hours, suggesting its potential for once-daily dosing in humans.
Silo Pharma's CEO, Eric Weisblum, stated that the successful completion of the GLP study would be significant, as it would enable the company to seek permission from the U.S. Food and Drug Administration (FDA) for first-in-human clinical studies in PTSD patients. Earlier this month, Silo submitted a pre-IND briefing package and meeting request to the FDA for SPC-15, which is a critical step before submitting an IND application.
SPC-15 utilizes a patented nose-to-brain delivery device and acts as a serotonin 4 (5-HT4) receptor agonist. It is designed to treat PTSD, anxiety, and other stress-induced affective disorders. If the drug proves to be clinically successful, it may be eligible for the FDA's streamlined 505(b)(2) regulatory pathway, potentially expediting the approval process.
The development of SPC-15 is part of Silo Pharma's broader focus on creating novel formulations and drug delivery systems for traditional therapeutics and psychedelic treatments. The company also has preclinical programs targeting Alzheimer’s disease, multiple sclerosis, fibromyalgia, and chronic pain.
In other recent news, Silo Pharma has made significant strides in the development of its SP-26 ketamine implant for chronic pain, with pre-clinical research showing promising results. The company is currently advancing towards identifying the optimal formulation for future testing. Concurrently, Silo Pharma has announced a registered direct offering and concurrent private placement of securities, with an aim to raise approximately $2 million. These funds are projected to be used for working capital and general corporate purposes.
The biopharmaceutical company has also initiated steps towards clinical trials for its PTSD treatment, SPC-15, after submitting a pre-Investigational New Drug briefing package to the U.S. Food and Drug Administration. Additionally, Silo Pharma has reported encouraging results from a study on a new drug formulation for depression treatment, potentially improving mood stability and extending remission periods for patients.
Lastly, Silo Pharma is set to participate in an FDA-sponsored public meeting to discuss the use of ketamine in emerging therapeutic areas. This is in line with their ongoing development of several drug candidates featuring ketamine as a primary therapeutic agent, including SP-26, a time-release ketamine-loaded implant for pain relief.
InvestingPro Insights
As Silo Pharma Inc. (NASDAQ:SILO) advances its SPC-15 intranasal therapeutic towards human clinical trials, the company's financial health and market performance provide additional context for investors tracking its progress. According to InvestingPro data, Silo Pharma holds a market capitalization of 3.98 million USD, reflecting its size within the biopharmaceutical industry. The company's impressive gross profit margin, standing at 91.9% for the last twelve months as of Q1 2024, underscores its potential to generate substantial profits from its revenues, a positive sign for its financial strength.
Despite the challenges often faced by biopharmaceutical companies in achieving profitability, one of the InvestingPro Tips highlights that Silo Pharma maintains a solid liquidity position, with liquid assets exceeding short-term obligations. This indicates the company's ability to meet its immediate financial liabilities, an important consideration for investors given the capital-intensive nature of drug development.
Moreover, the company's stock has seen a significant return over the last week, with a 12.5% price total return, suggesting a recent uptick in investor confidence. Investors should note, however, that the stock has experienced volatility over broader time frames, with a 44.33% price total return decline over the last three months.
For those interested in a deeper analysis, InvestingPro offers additional insights and metrics for Silo Pharma, with a total of 12 InvestingPro Tips available. These tips can provide further guidance on the company's stock performance and financial health. To explore these insights, visit https://www.investing.com/pro/SILO and remember to use coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.