Silo Pharma Expands Development Agreement with Sever Pharma for Novel Ketamine Implant Therapeutic
Rhea-AI Summary
Silo Pharma (NASDAQ: SILO) has expanded its development agreement with Sever Pharma Solutions for its novel ketamine-based injectable implant, SP-26, targeting chronic pain and fibromyalgia. The collaboration aims to scale-up extrusion processes and continue analytical testing for this non-opioid treatment. SP-26 is a dissolvable ketamine-loaded implant designed for time-released, dose-controlled delivery.
CEO Eric Weisblum expressed satisfaction with the ongoing partnership, highlighting that Sever Pharma has been instrumental in earlier production and delivery system validation. This expanded agreement is expected to bring Silo closer to selecting the optimal final dosage and formulation for animal studies. If clinically successful, SP-26 could potentially qualify for the FDA's streamlined 505(b)(2) regulatory pathway for drug approval, potentially expediting its market entry.
Positive
- Expansion of development agreement with Sever Pharma for SP-26 ketamine implant
- Potential for streamlined FDA 505(b)(2) regulatory pathway if clinically successful
- Progress towards optimal dosage and formulation selection for animal studies
Negative
- SP-26 is still in pre-clinical testing phase, indicating a long path to potential market approval
- No guarantee of clinical success or FDA approval
Insights
The expansion of Silo Pharma's development agreement with Sever Pharma for the SP-26 ketamine implant is a significant step forward in addressing chronic pain and fibromyalgia. This novel approach using a dissolvable, injectable implant could revolutionize pain management by providing a controlled-release, non-opioid alternative.
The focus on scale-up extrusion and continued analytical testing indicates progress towards optimizing the formulation for pre-clinical studies. This methodical approach enhances the likelihood of developing a viable therapeutic. The potential for the FDA's 505(b)(2) pathway could accelerate the approval process, potentially bringing this innovative treatment to market faster.
However, investors should note that success in pre-clinical stages doesn't guarantee clinical efficacy or regulatory approval. The chronic pain market is highly competitive and the unique delivery system will need to demonstrate clear advantages over existing treatments to gain market share.
Silo Pharma's expanded agreement with Sever Pharma represents a positive development for the company's pipeline. The focus on SP-26, a novel ketamine-based implant for chronic pain and fibromyalgia, targets a substantial market opportunity. The global chronic pain treatment market was valued at
The potential use of the FDA's 505(b)(2) pathway could lead to faster approval and reduced development costs, which is financially advantageous for a developmental stage company like Silo. However, investors should be aware that the company is still in early stages, with no guarantee of successful clinical trials or eventual market approval.
While this news doesn't provide immediate financial impact, it demonstrates progress in Silo's development pipeline, which could positively influence investor sentiment and potentially support the company's valuation in the medium to long term.
SP-26 dissolvable ketamine-based injectable implant targets chronic pain and fibromyalgia
Sever Pharma to scale-up extrusion processes and continue analytical testing for novel non-opioid treatment
SARASOTA, FL, Aug. 14, 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 a new agreement with Sever Pharma Solutions for scale-up extrusion of the Company’s SP-26 ketamine-loaded implant therapeutic targeting fibromyalgia and chronic pain. In addition, Sever Pharma Solutions will continue with analytical testing of the ketamine hydrochloride (ketamine HCL) polymer implants using the optimal time-released, dose-controlled formulation previously selected by Silo for continuing pre-clinical studies.
“Sever Pharma Solutions has been our partner for earlier production of the ketamine implants and validation of the delivery system through successful assay testing,” said Silo CEO Eric Weisblum. “We are pleased to continue our collaboration as we move forward with further pre-clinical testing of our novel non-opioid chronic pain therapeutic. This process is expected to bring Silo closer to selecting the optimal final dosage and formulation in SP-26 to be utilized in animal studies
If clinically successful, SP-26 could qualify for the FDA’s streamlined 505(b)(2) regulatory pathway for drug approval.
About SP-26
Silo’s SP-26 is a ketamine-based injectable dissolvable polymer implant for the treatment of chronic pain and fibromyalgia. The subcutaneous implant is being designed to safely regulate dosage and time release of the pain-relieving treatment.
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 universities and independent laboratories. 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
800-705-0120
investors@silopharma.com
FAQ
What is Silo Pharma's SP-26 and what is it designed to treat?
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