Silo Pharma Enters Joint Development Agreement for SP-26 Ketamine Implant Device Targeting Pain Management
Silo Pharma (SILO) has entered a collaboration agreement with Kymanox to develop a subcutaneous insertion device for SP-26, their ketamine-loaded implant therapeutic targeting fibromyalgia and chronic pain. The agreement includes initial proof-of-concept design followed by prototype development and feasibility testing to determine optimal tissue insertion depth. Previous testing has confirmed the optimal formulation for SP-26 implants. The company aims to develop SP-26 as a potential first-in-class at-home injectable ketamine-based therapeutic, with preclinical research focusing on FDA safety requirements. Kymanox also serves as Silo's regulatory partner for SPC-15, a treatment for stress-induced affective disorders including PTSD.
Silo Pharma (SILO) ha stipulato un accordo di collaborazione con Kymanox per sviluppare un dispositivo di inserimento sottocutaneo per SP-26, il loro impianto terapeutico a base di ketamina mirato alla fibromialgia e al dolore cronico. L'accordo prevede la fase iniziale di progettazione della prova di concetto seguita dallo sviluppo del prototipo e dai test di fattibilità per determinare la profondità ottimale di inserimento nei tessuti. Test precedenti hanno confermato la formulazione ottimale per gli impianti SP-26. L'azienda punta a sviluppare SP-26 come potenziale terapia iniettabile a base di ketamina da utilizzare a domicilio, con ricerche precliniche focalizzate sui requisiti di sicurezza della FDA. Kymanox funge anche da partner regolatorio per Silo per SPC-15, un trattamento per i disturbi affettivi indotti dallo stress, compreso il PTSD.
Silo Pharma (SILO) ha entrado en un acuerdo de colaboración con Kymanox para desarrollar un dispositivo de inserción subcutánea para SP-26, su implante terapéutico cargado de ketamina dirigido a la fibromialgia y al dolor crónico. El acuerdo incluye un diseño inicial de prueba de concepto, seguido del desarrollo del prototipo y pruebas de viabilidad para determinar la profundidad óptima de inserción en los tejidos. Las pruebas anteriores han confirmado la formulación óptima para los implantes SP-26. La empresa tiene como objetivo desarrollar SP-26 como una posible terapia inyectable basada en ketamina de primera clase para el hogar, con investigaciones preclínicas centradas en los requisitos de seguridad de la FDA. Kymanox también actúa como socio regulatorio de Silo para SPC-15, un tratamiento para los trastornos afectivos inducidos por estrés, incluyendo el PTSD.
Silo Pharma (SILO)는 Kymanox와 협력하여 SP-26의 피하 삽입 장치를 개발하기 위한 협약을 체결했습니다. SP-26은 섬유근육통 및 만성 통증을 목표로 하는 케타민 주입 임플란트입니다. 이 협약에는 초기 개념 증명 설계와 프로토타입 개발, 최적의 조직 삽입 깊이를 결정하기 위한 타당성 테스트가 포함됩니다. 이전 테스트는 SP-26 임플란트의 최적 공식을 확인했습니다. 이 회사는 SP-26을 자택에서 사용할 수 있는 최초의 케타민 기반 주사 치료제로 개발하는 것을 목표로 하며, FDA 안전 요건에 초점을 맞춘 전임상 연구를 진행하고 있습니다. Kymanox는 또한 PTSD를 포함한 스트레스 유발 정서적 장애에 대한 치료제 SPC-15에 대한 Silo의 규제 파트너 역할을 하고 있습니다.
Silo Pharma (SILO) a conclu un accord de collaboration avec Kymanox pour développer un dispositif d'insertion sous-cutanée pour SP-26, leur implant thérapeutique chargé en kétamine ciblant la fibromyalgie et la douleur chronique. L'accord comprend la conception initiale d'une preuve de concept suivie du développement d'un prototype et de tests de faisabilité pour déterminer la profondeur d'insertion optimale dans les tissus. Des tests antérieurs ont confirmé la formulation optimale pour les implants SP-26. La société vise à développer SP-26 en tant que thérapie injectable à domicile, à base de kétamine, de première classe, avec une recherche préclinique axée sur les exigences de sécurité de la FDA. Kymanox est également le partenaire réglementaire de Silo pour SPC-15, un traitement des troubles affectifs induits par le stress, y compris le PTSD.
Silo Pharma (SILO) hat einen Kooperationsvertrag mit Kymanox geschlossen, um ein subkutanes Einführgerät für SP-26, ihr ketaminbeladenes Implantat zur Behandlung von Fibromyalgie und chronischen Schmerzen, zu entwickeln. Der Vertrag umfasst ein anfängliches Proof-of-Concept-Design, gefolgt von der Prototypenentwicklung und Machbarkeitstests zur Bestimmung der optimalen Gewebeeinführtiefe. Frühere Tests haben die optimale Formulierung für die SP-26-Implantate bestätigt. Das Unternehmen strebt an, SP-26 als potenzielle Therapie der ersten Klasse zu entwickeln, die zu Hause injiziert werden kann, wobei die präklinische Forschung sich auf die Sicherheitsanforderungen der FDA konzentriert. Kymanox dient auch als regulatorischer Partner von Silo für SPC-15, eine Behandlung für stressinduzierte affektive Störungen, einschließlich PTSD.
- Development of potentially first-at-home injectable ketamine-based therapeutic
- Successful completion of previous analytical testing and proof-of-concept trials
- Progress in development pathway with new device development agreement
- Product still in early development stage with no clinical data
- Uncertain timeline for FDA approval and commercialization
Insights
The development of a subcutaneous ketamine implant device represents an innovative approach in pain management, particularly for fibromyalgia patients. The collaboration with Kymanox for device development is a important step, but several technical and regulatory hurdles remain. The key differentiator is the potential for at-home administration, which could significantly expand market access compared to current ketamine treatments that require clinical supervision.
The focus on optimal insertion depth and tissue compatibility shows proper attention to safety considerations. However, ketamine's controlled substance status may complicate FDA approval for at-home use. The market opportunity is substantial - fibromyalgia affects approximately
Technical milestones to monitor:
- Safety data from preclinical studies
- Device prototype performance metrics
- FDA feedback on at-home use classification
Prototype development and feasibility testing underway for optimized subcutaneous delivery
SARASOTA, FL, Nov. 29, 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 collaboration agreement with Kymanox for specialized design and development of a subcutaneous insertion device for SP-26, the Company’s ketamine-loaded implant therapeutic targeting fibromyalgia and chronic pain.
Under terms of the agreement, Kymanox will conduct an initial proof-of-concept design phase followed by full system prototype and feasibility testing to determine optimal insertion depth in tissue.
“Previous analytical testing and proof-of-concept extrusion trials have confirmed the optimal formulation for our SP-26 implants. Now we are advancing this program to develop a novel insertion device that is intended to be tested in continuing preclinical studies,” said Silo CEO Eric Weisblum. “We are pleased with the steady progress we are making with our proposed ketamine implants, which are being uniquely designed with a goal of providing sustained relief of chronic pain.”
Preclinical research to date has focused, in part, on ensuring that the safety profile of SP-26 aligns with FDA requirements for potential at-home therapeutic designation. If approved, SP-26 could become the first at-home injectable ketamine-based therapeutic.
In addition to the SP-26 agreement, Kymanox is Silo’s regulatory partner for SPC-15, a targeted prophylactic treatment for stress-induced affective disorders including PTSD.
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. 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 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.
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