Biopharmaceutical Company Announces Master Plan With Medical Technology Provider
Biopharmaceutical Company Announces Master Plan With Medical Technology Provider
Silo Pharma and Resyca BV Enter Device and CMC Development Master Plan.
Disclaimer: This article provides information based on an announcement by Silo Pharma Inc. and Resyca BV. The details contained herein are intended for informational purposes only and should not be construed as professional or investment advice.
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Silo Pharma, Inc. (Nasdaq: SILO), a developmental stage biopharmaceutical company, announced that it has entered into a Device and CMC Development Master Plan with Resyca BV, a medical technology provider. This collaboration is particularly focused on the advancement of Silo's lead candidate, SPC-15, an intranasal prophylactic treatment for post-traumatic stress disorder (PTSD). Resyca BV is a joint venture between Bespak Group and Medspray Pharma BV. Notably, Medspray Pharma BV manufactures a formulation-specific microchip-based spray system chosen by Silo for developing SPC-15. With this new strategic partnership, both companies aim to make advancements in the treatment of PTSD.
Overview of the Partnership
The Device and CMC Development Master Plan between Silo Pharma and Resyca BV is structured to support the development, clinical formulation, and stability of SPC-15. This plan is crucial for the investigational new drug (IND)-enabling large animal GLP (Good Laboratory Practice) study of SPC-15. Silo Pharma already has an exclusive license agreement with Medspray Pharma BV, providing them with exclusive rights to use Medspray’s spray mist technology for multiple indications, including PTSD. Eric Weisblum, Chief Executive Officer of Silo Pharma, commented on the potential of this nasal spray system: “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. 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.”
The partnership shows the commitment of both companies to innovate in drug delivery systems and enhance therapeutic outcomes for patients suffering from PTSD and potentially other stress-induced affective disorders.
SPC-15 is a novel serotonin 4 (5-HT4) receptor agonist designed to utilize biomarkers for treating PTSD, anxiety, and other stress-induced affective disorders. The choice of an intranasal administration route for SPC-15 is based on its potential to facilitate direct nose-to-brain delivery, thus bypassing the blood-brain barrier. This method could potentially enhance the concentration of the therapeutic agent in the brain, leading to a faster onset of action and improved safety profile. If SPC-15 proves to be clinically successful, it could qualify for the FDA’s streamlined 505(b)(2) regulatory pathway for drug approval. This pathway allows for the approval of new formulations of previously approved drugs or new uses for approved drugs, thereby expediting the drug development process.
Silo Pharma is conducting preclinical studies of SPC-15 in collaboration with Columbia University. These studies include GLP-compliant pharmacokinetic and pharmacodynamic evaluations, which are essential steps before submitting an IND application to the FDA. Recently, Silo Pharma submitted a pre-IND briefing package and meeting request to the FDA for SPC-15, aiming to commence the first-in-human clinical trials.
Future Directions
Silo Pharma’s focus on developing novel formulations and drug delivery systems for traditional therapies and psychedelic treatments represents a step toward addressing underserved conditions such as stress-induced psychiatric disorders, chronic pain conditions, and central nervous system (CNS) diseases. The partnership with Resyca BV highlights the importance of innovation in drug delivery systems. By leveraging advanced technologies like the microchip-based spray system developed by Medspray Pharma BV, Silo Pharma aims to improve the therapeutic efficacy and safety of its drug candidates.
In addition to SPC-15, Silo Pharma is also developing other promising candidates, such as SP-26, a time-release ketamine-loaded implant for fibromyalgia and chronic pain relief. This diversification in their pipeline shows the company’s commitment to addressing a wide range of medical needs through innovative solutions. The Device and CMC Development Master Plan between Silo Pharma and Resyca BV represents a massive achievement in the development of SPC-15, an intranasal treatment for PTSD. This collaboration leverages cutting-edge drug delivery technology to potentially enhance therapeutic outcomes for patients suffering from PTSD and other stress-induced affective disorders.
By pursuing innovative approaches and forming strategic partnerships, Silo Pharma continues to make strides in the field of biopharmaceuticals, aiming to provide effective and safe treatments for various underserved medical conditions.
Disclaimer: This article provides information based on an announcement by Silo Pharma Inc. and Resyca BV. The details contained herein are intended for informational purposes only and should not be construed as professional or investment advice.
Real-time information is available daily at https://stockregion.net