Silo Pharma and Resyca BV Partner on Device and CMC Development for Intranasal PTSD Drug SPC-15
Silo Pharma (NASDAQ: SILO) has partnered with Resyca BV for the Device and CMC Development Master Plan of SPC-15, an intranasal PTSD treatment. This collaboration aims to support IND-enabling studies for SPC-15, which utilizes a patented nasal spray system for nose-to-brain drug delivery. The technology is expected to increase drug concentration in the brain, potentially offering faster therapeutic benefits and improved safety for PTSD patients.
Silo holds exclusive rights to Medspray's spray mist technology for multiple indications, including PTSD. The company is currently conducting GLP-compliant pharmacokinetic and pharmacodynamic studies and has submitted a pre-IND briefing package to the FDA. These steps are important for the eventual submission of an IND application, with the goal of initiating the first human clinical trial for SPC-15.
- Partnership with Resyca BV for Device and CMC Development Master Plan
- Exclusive rights to Medspray's spray mist technology for multiple indications
- Potential for faster onset of therapeutic benefit and optimized safety for PTSD patients
- Progress towards IND application submission
- Completion of GLP-compliant pharmacokinetic and pharmacodynamic studies
- SPC-15 is still in early development stages, with no human clinical trials yet
- Regulatory approval from FDA not yet obtained
- Potential risks associated with new drug delivery methods
Insights
In the field of intranasal drug delivery, the collaboration between Silo Pharma and Resyca BV is noteworthy. By leveraging Resyca’s microchip-based spray system, Silo aims to enhance the efficacy of SPC-15 for PTSD treatment. The technique of nose-to-brain drug delivery is designed to bypass the blood-brain barrier, potentially allowing a higher concentration of the drug to reach the brain more quickly than traditional methods. For PTSD patients, this could mean a faster onset of relief and possibly better overall outcomes.
Given that SPC-15 is still in pre-IND stages, it's essential to note the current studies' compliance with GLP standards. This adherence is critical as it ensures the study’s data integrity and reliability, which will be key in obtaining FDA approval.
While the approach shows promise, the effectiveness and safety need to be validated through further clinical trials. Investors should monitor the progress of SPC-15's IND application and the upcoming human clinical trials. If these trials demonstrate positive results, it could significantly enhance the company's valuation and market position in the biopharmaceutical sector.
From a financial perspective, the partnership with Resyca BV places Silo Pharma in a potentially advantageous position. Intranasal delivery systems, particularly those bypassing the blood-brain barrier, represent a cutting-edge niche with substantial market potential. SPC-15, targeting PTSD, addresses a significant unmet need in mental health pharmaceuticals.
Investors should closely watch the timeline for FDA submission and subsequent approval stages. Successful IND approval and subsequent clinical trials can act as critical catalysts for stock price appreciation. However, developmental stage biopharma companies like Silo often experience high volatility. The significant expenses associated with clinical trials and regulatory processes could impact short-term financial stability. Stakeholders should weigh these risks against the potential long-term benefits.
Additionally, Silo’s exclusive license for Medspray’s technology across multiple indications provides a potential pipeline beyond PTSD, which might mitigate some risks by diversifying future revenue opportunities.
Nose-to-Brain Drug Delivery Shows Promising Patient Safety and Therapeutic Benefit
The Device and CMC Development Master Plan is designed to support IND-enabling studies
SARASOTA, FL, July 18, 2024 (GLOBE NEWSWIRE) -- Silo Pharma, Inc. (Nasdaq: SILO) (“Silo” or the “Company”), a developmental stage biopharmaceutical company focused on developing novel formulations and drug delivery systems for traditional therapeutics and psychedelic treatments, today announced it has entered into a Device and CMC Development Master Plan with Resyca BV, a medical technology provider. Resyca is a joint venture between Bespak Group and Medspray Pharma BV which manufactures the formulation-specific microchip-based spray system chosen by Silo for its lead candidate SPC-15, an intranasal prophylactic treatment for post-traumatic stress disorder (PTSD).
“The patented nasal spray system uses cutting-edge nose-to-brain drug dispersion, a delivery method that transports the molecules to the brain directly, bypassing the blood-brain barrier,” said Eric Weisblum, Chief Executive Officer of Silo Pharma. “For SPC-15, we believe this delivery method could increase the drug’s concentration in the brain to deliver a faster onset of therapeutic benefit and optimized safety for PTSD patients.”
This Device and CMC Development Master Plan is intended to support the development, clinical formulation, and stability of a previously announced investigational new drug (IND)-enabling, large animal GLP (Good Laboratory Practice) study of SPC-15. As part of an existing exclusive license agreement with Medspray Pharma BV, one of joint venture members of Resyca BV, Silo holds exclusive rights to Medspray’s spray mist technology for use with multiple indications including PTSD.
Silo is currently conducting a GLP-compliant pharmacokinetic and pharmacodynamic studies and recently submitted a pre-IND briefing package and meeting request to the U.S. Food and Drug Administration (FDA) for SPC-15. The studies are the final steps required before submission of an IND application to the FDA with the goal of starting its first in human clinical trial.
About SPC-15
SPC-15 is a novel serotonin 4 (5-HT4) receptor agonist that utilizes biomarkers for the treatment of PTSD, anxiety, and other stress-induced affective disorders. SPC-15 is being developed as an intranasal medication. If clinically successful, SPC-15 could qualify for the FDA’s streamlined 505(b)(2) regulatory pathway for drug approval. Silo Pharma is conducting preclinical studies of SPC-15 in collaboration with Columbia University and was granted an exclusive license to further develop, manufacture, and commercialize SPC-15 worldwide.
About Silo Pharma
Silo Pharma Inc. (Nasdaq: SILO) is a developmental stage biopharmaceutical company developing novel therapeutics that address underserved conditions including stress-induced psychiatric disorders, chronic pain conditions, and central nervous system (CNS) diseases. Silo focuses on developing traditional therapies and psychedelic treatments in novel formulations and drug delivery systems. The Company’s lead program, SPC-15, is an intranasal treatment targeting PTSD and stress-induced anxiety disorders. SP-26 is a time-release ketamine-loaded implant for fibromyalgia and chronic pain relief. Silo’s two preclinical programs are SPC-14, an intranasal compound for the treatment of Alzheimer’s disease, and SPU-16, a CNS-homing peptide targeting multiple sclerosis (MS). Silo’s research and development programs are conducted through collaborations with Columbia University and the University of Maryland, Baltimore. For more information, visit www.silopharma.com and connect on social media at LinkedIn, X, and Facebook.
Forward-Looking Statements
This news release contains "forward-looking statements" within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. These statements are identified by the use of words “could”, “believe”, “anticipate”, “intend”, “estimate”, “expect”, “may”, “continue”, “predict”, “potential”, and similar expressions that are intended to identify forward-looking statements. Such statements involve known and unknown risks, uncertainties, and other factors that could cause the actual results of Silo Pharma, Inc. (“Silo” or “the Company”) to differ materially from the results expressed or implied by such statements, including changes to anticipated sources of revenues, future economic and competitive conditions, difficulties in developing the Company’s technology platforms, retaining and expanding the Company’s customer base, fluctuations in consumer spending on the Company’s products and other factors. Accordingly, although the Company believes that the expectations reflected in such forward-looking statements are reasonable, there can be no assurance that such expectations will prove to be correct. The Company disclaims any obligations to publicly update or release any revisions to the forward-looking information contained in this presentation, whether as a result of new information, future events, or otherwise, after the date of this presentation or to reflect the occurrence of unanticipated events except as required by law.
Contact
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FAQ
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