Silo Pharma’s SP-26 Ketamine Implant Meets All Endpoints in Fibromyalgia Study
Silo Pharma announced positive results from its preclinical study of SP-26, a novel extended-release ketamine implant for fibromyalgia treatment. The study, conducted in minipigs, met all endpoints including safety, tolerability, and sustained drug release.
Key findings include:
- No adverse events reported, with animals maintaining healthy weight and normal behavior
- Sustained ketamine release for up to 22 days post-implantation
- Minimal tissue inflammation at implant sites
- Peak drug levels achieved within 1 hour
SP-26 aims to provide sustained, sub-psychedelic ketamine levels in an abuse-deterrent format, potentially becoming the first at-home injectable ketamine-based therapeutic. The successful preclinical results position Silo to advance toward clinical studies for chronic pain and mental health treatments.
Silo Pharma ha annunciato risultati positivi dal suo studio preclinico su SP-26, un innovativo impianto a rilascio prolungato di ketamina per il trattamento della fibromialgia. Lo studio, condotto su miniporcini, ha soddisfatto tutti gli obiettivi, inclusi sicurezza, tollerabilità e rilascio sostenuto del farmaco.
I principali risultati includono:
- Assenza di eventi avversi, con gli animali che hanno mantenuto un peso sano e un comportamento normale
- Rilascio continuo di ketamina fino a 22 giorni dopo l'impianto
- Infiammazione tissutale minima nei siti di impianto
- Massimi livelli del farmaco raggiunti entro 1 ora
SP-26 mira a fornire livelli sostenuti di ketamina sub-psichedelica in un formato che previene l'abuso, potenzialmente diventando il primo trattamento a base di ketamina iniettabile da utilizzare a casa. I risultati preclinici positivi posizionano Silo per avanzare verso studi clinici per il trattamento del dolore cronico e delle patologie mentali.
Silo Pharma anunció resultados positivos de su estudio preclínico sobre SP-26, un novedoso implante de ketamina de liberación prolongada para el tratamiento de la fibromialgia. El estudio, realizado en minicerdos, cumplió con todos los objetivos, incluyendo seguridad, tolerabilidad y liberación sostenida del medicamento.
Los hallazgos clave incluyen:
- No se reportaron eventos adversos, con los animales manteniendo un peso saludable y comportamiento normal
- Liberación sostenida de ketamina hasta 22 días después de la implantación
- Mínima inflamación tisular en los sitios de implantación
- Niveles máximos del medicamento alcanzados en 1 hora
SP-26 busca proporcionar niveles sostenidos de ketamina sub-psicodélica en un formato que disuade el abuso, potencialmente convirtiéndose en el primer tratamiento inyectable a base de ketamina para uso en el hogar. Los resultados preclínicos exitosos posicionan a Silo para avanzar hacia estudios clínicos para el tratamiento del dolor crónico y la salud mental.
Silo Pharma는 섬유근육통 치료를 위한 새로운 장기지속형 케타민 임플란트인 SP-26의 전임상 연구에서 긍정적인 결과를 발표했습니다. 미니피그를 대상으로 한 이번 연구는 안전성, 내약성, 지속적인 약물 방출 등 모든 평가 지표를 충족했습니다.
주요 결과는 다음과 같습니다:
- 부작용 보고 없음, 동물들은 건강한 체중과 정상적인 행동 유지
- 임플란트 후 최대 22일간 지속적인 케타민 방출
- 임플란트 부위의 조직 염증 최소화
- 약물 최고 농도 1시간 이내 도달
SP-26는 남용 방지 형식으로 지속적이고 정신활성 효과가 낮은 케타민 수치를 제공하는 것을 목표로 하며, 가정에서 사용할 수 있는 최초의 주사형 케타민 치료제가 될 가능성이 있습니다. 성공적인 전임상 결과는 Silo가 만성 통증 및 정신 건강 치료를 위한 임상 연구로 나아갈 수 있는 기반을 마련합니다.
Silo Pharma a annoncé des résultats positifs issus de son étude préclinique sur SP-26, un nouvel implant à libération prolongée de kétamine pour le traitement de la fibromyalgie. L'étude, réalisée sur des mini-porcs, a atteint tous les objectifs, incluant la sécurité, la tolérance et la libération soutenue du médicament.
Les principales conclusions sont :
- Aucun événement indésirable rapporté, les animaux conservant un poids sain et un comportement normal
- Libération soutenue de kétamine jusqu'à 22 jours après l'implantation
- Inflammation tissulaire minimale aux sites d'implantation
- Pic des niveaux du médicament atteint en moins d'une heure
SP-26 vise à fournir des niveaux soutenus de kétamine sub-psychédélique dans un format dissuasif contre l'abus, pouvant devenir le premier traitement injectable à base de kétamine utilisable à domicile. Ces résultats précliniques positifs positionnent Silo pour avancer vers des études cliniques pour les traitements de la douleur chronique et des troubles mentaux.
Silo Pharma gab positive Ergebnisse seiner präklinischen Studie zu SP-26 bekannt, einem neuartigen Ketamin-Implantat mit verlängerter Wirkstofffreisetzung zur Behandlung von Fibromyalgie. Die Studie, durchgeführt an Minischweinen, erfüllte alle Endpunkte, einschließlich Sicherheit, Verträglichkeit und anhaltende Wirkstofffreisetzung.
Wesentliche Erkenntnisse umfassen:
- Keine unerwünschten Ereignisse, die Tiere behielten ein gesundes Gewicht und normales Verhalten bei
- Anhaltende Ketaminfreisetzung bis zu 22 Tage nach der Implantation
- Minimale Gewebeentzündung an den Implantationsstellen
- Maximale Wirkstoffspiegel innerhalb von 1 Stunde erreicht
SP-26 zielt darauf ab, anhaltende, sub-psychedelische Ketaminspiegel in einem Missbrauchs-abschreckenden Format bereitzustellen und könnte die erste ketaminbasierte Injektionstherapie für den Heimgebrauch werden. Die erfolgreichen präklinischen Ergebnisse positionieren Silo, um klinische Studien für chronische Schmerz- und psychische Gesundheitsbehandlungen voranzutreiben.
- SP-26 ketamine implant met all endpoints in fibromyalgia preclinical study
- Successful safety profile with no implant-related adverse events observed
- Sustained drug release achieved for up to 22 days post-implantation
- Potential first-to-market advantage as at-home injectable ketamine therapeutic
- Drug delivery system avoids dissociative effects of IV ketamine
- Provides alternative to addictive opioid treatments
- Still in preclinical stage, requiring lengthy clinical trials before potential approval
- Study conducted only in minipigs, human trials yet to begin
- No efficacy data presented for actual pain reduction in fibromyalgia
Insights
Silo Pharma's ketamine implant achieves key preclinical milestones, demonstrating sustained release and safety profile needed to advance toward clinical trials.
The preclinical study results for Silo Pharma's SP-26 ketamine implant represent a significant early-stage development milestone. The minipig study successfully met all predetermined endpoints, including survival, clinical observations, body weight stability, neurological assessments, and histopathological evaluation - providing a comprehensive safety profile assessment.
The pharmacokinetic data reveals two particularly promising characteristics: (1) measurable ketamine release was sustained for up to 22 days post-implantation, and (2) the implants elicited only minimal to mild chronic inflammation at insertion sites. This extended-release profile directly addresses the primary limitations of traditional ketamine administration by avoiding the dissociative effects associated with IV bolus injection.
SP-26's technical design as a controlled-release subcutaneous implant delivering sub-psychedelic ketamine levels represents a novel approach to fibromyalgia treatment. The abuse-deterrent formulation also provides a potential alternative to opioid-based therapies, addressing a critical need in pain management.
These positive preclinical results position Silo to advance toward IND filing and clinical studies. Their stated objective of pursuing at-home therapeutic designation represents a strategic regulatory pathway that could differentiate SP-26 in the pain management market if successful in future clinical trials.
Positive preclinical results strengthen Silo's development pipeline, addressing major unmet needs in fibromyalgia treatment with novel drug delivery technology.
Silo Pharma's announcement that SP-26 met all study endpoints represents a significant technical validation of their novel extended-release ketamine implant. For developmental-stage biopharmaceutical companies, successful preclinical studies are crucial de-risking events that validate core technology and support advancement toward clinical testing.
The study data demonstrates several commercially valuable attributes: sustained drug release maintained for 22 days, rapid achievement of therapeutic levels (peak concentrations within 1 hour), and minimal tissue reaction - all essential characteristics for implantable drug delivery systems.
The fibromyalgia indication represents a substantial market opportunity with significant limitations in current treatment options. SP-26's dual differentiation as both an alternative to addictive opioid therapies and a controlled-release formulation that avoids ketamine's dissociative effects addresses key treatment challenges.
The company's strategic positioning of SP-26 as potentially "the first at-home injectable ketamine-based therapeutic" could provide significant commercial differentiation if successful through clinical development. However, investors should recognize that considerable development work remains, as preclinical success is an early milestone in the lengthy drug development and approval process. The press release doesn't provide specific timelines for IND submission or clinical trial initiation.
— Successfully demonstrates strong tolerability, sustained drug release and safety
SARASOTA, FL, April 30, 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 positive results for its preclinical study evaluating SP-26, a novel extended-release ketamine implant which it believes supports SP-26’s potential as a safe, well-tolerated, and long-acting treatment for fibromyalgia.
All study endpoints were met, including survival, clinical observations, body weight stability, neurological assessments, and histopathological evaluation.
“Our team is pleased to report that SP-26 met all expectations in this preclinical study,” said Eric Weisblum, CEO of Silo Pharma. “We believe these results support the advancement of SP-26 as a next-generation therapeutic for fibromyalgia, combining the proven efficacy of ketamine with the safety and convenience of extended-release delivery.”
The study, which was conducted in minipigs, evaluated the pharmacokinetics, safety, and local tolerability of SP-26 formulations when administered subcutaneously. SP-26 implants are designed to deliver ketamine at a controlled rate, avoiding the dissociative effects associated with IV bolus injection and providing a viable alternative to highly addictive opioid treatments. The preclinical results position Silo to advance toward clinical studies and expand the Company’s pipeline for chronic pain and mental health indications.
Study Highlights:
• Safety Profile: No implant-related adverse events were observed. Animals maintained a healthy weight, normal neurological behavior, and full survival to study conclusion.
• Sustained Drug Release: Ketamine was steadily released post-implantation, with measurable systemic exposure achieved across all dose levels. Peak drug levels were reached within 1 hour in most subjects, with sustained plasma concentrations observed for up to 22 days.
• Minimal Tissue Reaction: Both formulations elicited only minimal to mild chronic inflammation at the implant sites, with no dose-dependent or formulation-specific differences.
“SP-26 has been designed to offer a new approach to pain management by providing sustained, sub-psychedelic levels of ketamine in an abuse-deterrent format,” Weisblum added. “Preclinical SP-26 research overall has focused 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.”
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:
800-705-0120
investors@silopharma.com
FAQ
What results did Silo Pharma (SILO) achieve in its SP-26 ketamine implant study for fibromyalgia?
How long does Silo Pharma's (SILO) SP-26 ketamine implant release medication?
What makes Silo Pharma's (SILO) SP-26 different from traditional ketamine treatments?
What are the safety findings for Silo Pharma's (SILO) SP-26 ketamine implant?
How does Silo Pharma's (SILO) SP-26 address the opioid addiction problem?
