Silo Pharma Initiates Pharmacokinetic and Tolerability Study for SP-26 Targeting Chronic Pain and Fibromyalgia
Silo Pharma (NASDAQ: SILO) has initiated a pharmacokinetic (PK) and tolerability study for SP-26, its dissolvable ketamine-based injectable implant targeting chronic pain and fibromyalgia. The three-week non-GLP study, conducted in partnership with AmplifyBio, will evaluate the absorption, distribution, metabolism, and excretion of extended-release ketamine hydrochloride implants in a minipig model. Two different polymer formulations will be tested at various dose levels.
This milestone follows several previous studies including analytical testing, proof-of-concept extrusion trials, manufacturing evaluation, and sterilization tests. SP-26 is being developed as a self-administered, non-opioid therapeutic and aims to be a first-of-its-kind ketamine treatment for chronic pain.
Silo Pharma (NASDAQ: SILO) ha avviato uno studio di farmacocinetica (PK) e tollerabilità per SP-26, il suo impianto iniettabile a base di ketamina dissolvibile mirato al dolore cronico e alla fibromialgia. Lo studio di tre settimane, non GLP, condotto in collaborazione con AmplifyBio, valuterà l'assorbimento, la distribuzione, il metabolismo e l'escrezione degli impianti di ketamina cloridrato a rilascio prolungato in un modello di mini-pig. Due diverse formulazioni polimeriche saranno testate a vari livelli di dosaggio.
Questo traguardo segue diversi studi precedenti, tra cui test analitici, prove di fattibilità di estrusione, valutazione della produzione e test di sterilizzazione. SP-26 è in fase di sviluppo come terapia non oppioide a somministrazione autonoma e mira a essere un trattamento innovativo con ketamina per il dolore cronico.
Silo Pharma (NASDAQ: SILO) ha iniciado un estudio de farmacocinética (PK) y tolerancia para SP-26, su implante injectable de ketamina disoluble dirigido al dolor crónico y la fibromialgia. El estudio de tres semanas, no GLP, realizado en colaboración con AmplifyBio, evaluará la absorción, distribución, metabolismo y excreción de implantes de clorhidrato de ketamina de liberación extendida en un modelo de minipig. Se probarán dos formulaciones poliméricas diferentes a varios niveles de dosis.
Este hito sigue a varios estudios previos que incluyen pruebas analíticas, ensayos de prueba de concepto, evaluación de fabricación y pruebas de esterilización. SP-26 se está desarrollando como una terapia no opioide autoadministrada y busca ser un tratamiento innovador con ketamina para el dolor crónico.
시로 фарма (NASDAQ: SILO)는 만성 통증 및 섬유근육통을 겨냥한 용해성 케타민 기반 주입형 임플란트 SP-26에 대한 약리학적 동태 (PK) 및 내약성 연구를 시작했습니다. AmplifyBio와 협력하여 수행되는 3주 비-GLP 연구는 미니피그 모델에서 지속 방출 케타민 염산염 임플란트의 흡수, 분포, 대사 및 배설을 평가할 것입니다. 두 가지 다른 고분자 제형이 다양한 용량 수준에서 테스트될 예정입니다.
이 이정표는 분석 테스트, 개념 증명 압출 실험, 제조 평가 및 멸균 테스트를 포함한 여러 이전 연구에 이어지고 있습니다. SP-26은 자가 투여 가능한 비-opioid 치료법으로 개발되고 있으며 만성 통증을 위한 독창적인 케타민 치료법이 되는 것을 목표로 하고 있습니다.
Silo Pharma (NASDAQ: SILO) a lancé une étude de pharmacocinétique (PK) et de tolérance pour SP-26, son implant injectable à base de kétamine dissoute ciblant la douleur chronique et la fibromyalgie. L'étude de trois semaines, non-GLP, réalisée en partenariat avec AmplifyBio, évaluera l'absorption, la distribution, le métabolisme et l'excrétion des implants de chlorhydrate de kétamine à libération prolongée dans un modèle de mini-cochon. Deux formulations polymériques différentes seront testées à divers niveaux de dosage.
Cette réalisation fait suite à plusieurs études précédentes comprenant des tests analytiques, des essais de preuve de concept, des évaluations de fabrication et des tests de stérilisation. SP-26 est en cours de développement en tant que thérapie non-opioïde à auto-administration et vise à être un traitement innovant à base de kétamine pour la douleur chronique.
Silo Pharma (NASDAQ: SILO) hat eine pharmakokinetische (PK) und Verträglichkeitsstudie für SP-26, sein lösliches ketaminbasiertes injizierbares Implantat zur Behandlung von chronischen Schmerzen und Fibromyalgie, gestartet. Die dreiwöchige nicht-GLP-Studie, die in Zusammenarbeit mit AmplifyBio durchgeführt wird, wird die Absorption, Verteilung, den Stoffwechsel und die Ausscheidung von Depot-Ketaminhydrochlorid-Implantaten in einem Minipig-Modell bewerten. Zwei verschiedene Polymerformulierungen werden auf verschiedenen Dosierungsniveaus getestet.
Dieser Meilenstein folgt mehreren vorherigen Studien, darunter analytische Tests, Machbarkeitsstudien zur Extrusion, Herstellungsbewertungen und Sterilisationstests. SP-26 wird als selbstverabreichende, nicht-opioide Therapie entwickelt und soll eine neuartige Ketaminbehandlung für chronische Schmerzen sein.
- Advancement to animal studies phase represents significant milestone in drug development
- SP-26 potentially represents first-of-its-kind ketamine treatment for chronic pain
- Previous studies showed encouraging results in analytical testing and proof-of-concept trials
- Study is non-GLP, indicating early stage of development
- No efficacy data available yet
Insights
Key preclinical milestone for novel, non-opioid extended-release pain therapeutic
SARASOTA, FL, Dec. 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 the initiation of a pharmacokinetic (PK) and tolerability study in partnership with its contract research organization (CRO), AmplifyBio. The study is designed to assess the pharmacokinetics of Silo’s dissolvable ketamine-based injectable implant, SP-26, in a minipig model. SP-26 is being developed as a self-administered, non-opioid therapeutic aimed at treating chronic pain and fibromyalgia.
The non-GLP study, set to span three weeks, will investigate the absorption, distribution, metabolism, and excretion (ADME) of extended-release ketamine hydrochloride implants. Two distinct polymer formulations will be tested at varying dose levels.
“So far this year we have conducted several studies of our SP-26 ketamine implants including analytical testing and small batch proof-of-concept extrusion trials, manufacturing and production evaluation, and sterilization and dissolution tests, with what we believe are encouraging results,” said Silo CEO Eric Weisblum. “The advancement of this program into animal studies is an important milestone achievement as we work to bring a safe and effective and to our knowledge, first-of-its-kind ketamine treatment for those living with chronic pain.”
“AmplifyBio is honored to support Silo Pharma in this critical safety milestone for SP-26. We understand and take seriously the trust put in us to execute the PK study efficiently and with excellence,” said Jerry Hacker, EVP, and Chief Commercial Officer for AmplifyBio.
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 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 news release, whether as a result of new information, future events, or otherwise, after the date of this news release or to reflect the occurrence of unanticipated events except as required by law.
Contact
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FAQ
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