Silo Pharma Announces Positive Initial Pharmacokinetic, Safety, and Tolerability Study of SP-26 for Chronic Pain and Fibromyalgia
Silo Pharma (NASDAQ: SILO) reported positive initial results from its ongoing study of SP-26, a novel ketamine extended-release rod implant designed for chronic pain and fibromyalgia treatment. The non-GLP small animal testing, which began in December 2024, showed no serious side effects or discomfort following implantation in early January 2025.
The SP-26 implant is being developed as a self-administered, non-opioid therapeutic. The study is currently in the final stages of Absorption, Distribution, Metabolism, and Excretion (ADME) testing, with final safety and pharmacokinetic reports expected in March 2025.
Silo Pharma (NASDAQ: SILO) ha riportato risultati iniziali positivi dal suo studio in corso su SP-26, un innovativo impianto a rilascio prolungato di ketamina progettato per il trattamento del dolore cronico e della fibromialgia. I test su piccoli animali, non GLP, iniziati a dicembre 2024, non hanno mostrato effetti collaterali seri né disagio dopo l'impianto nei primi di gennaio 2025.
L'impianto SP-26 è in fase di sviluppo come terapia non oppioide autoadministrata. Lo studio è attualmente nelle fasi finali dei test di Assorbimento, Distribuzione, Metabolismo ed Escrezione (ADME), con i rapporti finali sulla sicurezza e sulla farmacocinetica previsti per marzo 2025.
Silo Pharma (NASDAQ: SILO) reportó resultados iniciales positivos de su estudio en curso sobre SP-26, un nuevo implante de liberación prolongada de ketamina diseñado para el tratamiento del dolor crónico y la fibromialgia. Las pruebas en pequeños animales, que comenzaron en diciembre de 2024, no mostraron efectos secundarios graves ni incomodidad tras la implantación a principios de enero de 2025.
El implante SP-26 se está desarrollando como una terapia no opioide autoadministrada. El estudio se encuentra actualmente en las etapas finales de las pruebas de Absorción, Distribución, Metabolismo y Excreción (ADME), con los informes finales de seguridad y farmacocinética esperados para marzo de 2025.
Silo Pharma (NASDAQ: SILO)는 만성 통증 및 섬유근육통 치료를 위해 설계된 새로운 케타민 장기 방출 로드 임플란트인 SP-26에 대한 진행 중인 연구에서 긍정적인 초기 결과를 보고했습니다. 2024년 12월에 시작된 비 GLP 소동물 실험에서는 2025년 1월 초 임플란트 후 심각한 부작용이나 불편함이 나타나지 않았습니다.
SP-26 임플란트는 자가 투여 가능한 비 오피오이드 치료제로 개발되고 있습니다. 본 연구는 현재 흡수, 분포, 대사 및 배설(ADME) 테스트의 최종 단계에 있으며, 최종 안전성 및 약리학적 보고서는 2025년 3월에 발표될 예정입니다.
Silo Pharma (NASDAQ: SILO) a rapporté des résultats initiaux positifs de son étude en cours sur SP-26, un nouvel implant à libération prolongée de kétamine conçu pour le traitement de la douleur chronique et de la fibromyalgie. Les tests sur de petits animaux, non-GLP, commencés en décembre 2024, n'ont montré aucun effet secondaire grave ni d'inconfort après l'implantation début janvier 2025.
L'implant SP-26 est en cours de développement en tant que thérapie non-opioïde autoadministrée. L'étude est actuellement dans les dernières phases de tests d'Absorption, de Distribution, de Métabolisme et d'Excrétion (ADME), avec des rapports finaux sur la sécurité et la pharmacocinétique attendus pour mars 2025.
Silo Pharma (NASDAQ: SILO) hat positive erste Ergebnisse aus seiner laufenden Studie zu SP-26, einem neuartigen Ketamin-Depot-Implantat zur Behandlung von chronischen Schmerzen und Fibromyalgie, berichtet. Die nicht-GLP Tierversuche, die im Dezember 2024 begonnen wurden, zeigten nach der Implantation Anfang Januar 2025 keine schwerwiegenden Nebenwirkungen oder Beschwerden.
Das SP-26-Implantat wird als selbstverabreichte, nicht-opioide Therapie entwickelt. Die Studie befindet sich derzeit in den letzten Phasen der Tests zu Absorption, Verteilung, Metabolismus und Exkretion (ADME), und die endgültigen Sicherheits- und Pharmakokinetikberichte werden für März 2025 erwartet.
- Initial safety data shows no serious side effects or discomfort in animal testing
- Study progressing on schedule with final results expected March 2025
- Still in early preclinical stage with no human trial data
- Final safety and absorption data yet to be confirmed
Insights
The preliminary results from Silo Pharma's SP-26 preclinical study represent a significant milestone in addressing the $130 billion global chronic pain market. The development of a subcutaneous ketamine implant is particularly noteworthy as it could revolutionize pain management through controlled release technology, potentially offering sustained relief without the addiction risks associated with opioids.
The absence of serious adverse effects in the animal study is particularly encouraging, as safety is a primary concern in novel drug delivery systems. The subcutaneous rod format could solve several key challenges in ketamine therapeutics: controlled dosing, improved bioavailability and patient compliance. The non-GLP study, while preliminary, is a important step that typically precedes the more rigorous GLP toxicology studies required for IND (Investigational New Drug) submission.
Looking ahead, the March 2025 ADME data will be critical in determining the drug's:
- Absorption rate and bioavailability through the subcutaneous route
- Distribution patterns throughout the body
- Metabolic pathway and potential drug interactions
- Elimination profile and duration of therapeutic effect
If the final data package confirms these initial positive signals, Silo Pharma could potentially advance to GLP toxicology studies by late 2025, setting the stage for potential IND filing in 2026. However, investors should note that early-stage drug development carries significant risks and successful animal studies don't guarantee clinical efficacy in humans.
No serious side effects or discomfort observed
Final safety and absorption data expected in March 2025
SARASOTA, FL, Feb. 11, 2025 (GLOBE NEWSWIRE) -- Silo Pharma, Inc. (Nasdaq: SILO) (“Silo” or the “Company”), a developmental stage biopharmaceutical company focused on novel therapeutics and drug delivery systems, today announced a positive update from an ongoing study evaluating the pharmacokinetics, safety and tolerability of its novel SP-26 ketamine extended-release rods when implanted subcutaneously. The SP-26 implant is a novel self-administered, non-opioid therapeutic intended for the treatment of chronic pain and fibromyalgia.
The launch of our non-GLP study in December 2024 marked the first small animal testing of SP-26, a key preclinical milestone. Implantation (dosing) was completed in the first week of January 2025 and no animals experienced serious side effects or discomfort. Absorption, distribution, metabolism, and excretion (ADME) testing is nearing completion and final safety, and pharmacokinetic reports are expected in March 2025.
“We are encouraged by the early initial data from the SP-26 animal study, with no abnormal clinical observations reported so far,” said Eric Weisblum, CEO of Silo. “We believe that a successful final outcome would provide clear, actionable data for validating the advancing of SP-26 as a potential treatment for chronic pain.”
About SP-26
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. If clinically successful, SP-26 could qualify for the FDA’s streamlined 505(b)(2) regulatory pathway for drug approval.
About Silo Pharma
Silo Pharma Inc. (Nasdaq: SILO) is a developmental stage biopharmaceutical company focused on addressing underserved conditions, including stress-induced psychiatric disorders, chronic pain, and central nervous system (CNS) diseases. The Company’s portfolio includes innovative programs such as SPC-15 for PTSD, SP-26 for fibromyalgia and chronic pain, and preclinical assets targeting Alzheimer’s disease and multiple sclerosis. Silo’s research is conducted in collaboration with leading universities and laboratories. silopharma.com
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 using 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 press release, whether as a result of new information, future events, or otherwise, after the date of this press release or to reflect the occurrence of unanticipated events except as required by law.
Contact
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investors@silopharma.com
FAQ
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