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Silo Pharma Reports Positive Results in Sterilization and Dissolution Testing of SP-26 Ketamine Implant

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Silo Pharma (SILO) announced positive results from sterilization and dissolution tests of its SP-26 ketamine-loaded implant for fibromyalgia and chronic pain. The tests, conducted under a development agreement with Sever Pharma Solutions, showed the implant achieved over 80% drug release over a 7-day period with consistent delivery. The implants demonstrated minimal variation in physical properties, indicating safety and stability. The company plans to proceed with animal studies to evaluate the efficacy of these dose-controlled, time-release implants for fibromyalgia and chronic pain treatment.

Silo Pharma (SILO) ha annunciato risultati positivi dai test di sterilizzazione e dissoluzione del suo impianto caricato con ketamina SP-26 per la fibromialgia e il dolore cronico. I test, condotti nell'ambito di un accordo di sviluppo con Sever Pharma Solutions, hanno mostrato che l'impianto ha raggiunto oltre il 80% di rilascio del farmaco in un periodo di 7 giorni con una somministrazione costante. Gli impianti hanno dimostrato una variazione minima nelle proprietà fisiche, indicando sicurezza e stabilità. L'azienda prevede di procedere con studi sugli animali per valutare l'efficacia di questi impianti a rilascio controllato e temporale per il trattamento della fibromialgia e del dolore cronico.

Silo Pharma (SILO) anunció resultados positivos de las pruebas de esterilización y disolución de su implante cargado de ketamina SP-26 para la fibromialgia y el dolor crónico. Las pruebas, realizadas bajo un acuerdo de desarrollo con Sever Pharma Solutions, mostraron que el implante logró más de 80% de liberación del fármaco en un período de 7 días con una entrega consistente. Los implantes demostraron una variación mínima en las propiedades físicas, lo que indica seguridad y estabilidad. La empresa planea avanzar con estudios en animales para evaluar la eficacia de estos implantes de liberación controlada y temporal para el tratamiento de la fibromialgia y el dolor crónico.

시로 제약(SILO)은 섬유근육통 및 만성 통증을 위한 SP-26 케타민 장치의 살균 및 용해 테스트에서 긍정적인 결과를 발표했습니다. Sever Pharma Solutions와의 개발 협약에 따라 수행된 이 테스트에서 이 장치는 7일 동안 80% 이상의 약물 방출을 달성하며 일관된 전달을 보여주었습니다. 이 장치는 물리적 특성에서 최소한의 변화를 나타내어 안전성과 안정성을 암시합니다. 회사는 섬유근육통 및 만성 통증 치료를 위한 이들 용량 조절, 시간 방출 장치의 효능을 평가하기 위해 동물 연구를 진행할 계획입니다.

Silo Pharma (SILO) a annoncé des résultats positifs des tests de stérilisation et de dissolution de son implant chargé en kétamine SP-26 pour la fibromyalgie et la douleur chronique. Les tests, réalisés dans le cadre d'un accord de développement avec Sever Pharma Solutions, ont montré que l'implant avait atteint plus de 80% de libération du médicament sur une période de 7 jours avec une délivrance constante. Les implants ont montré une variation minimale dans les propriétés physiques, indiquant sécurité et stabilité. L'entreprise prévoit de poursuivre des études sur les animaux pour évaluer l'efficacité de ces implants à libération contrôlée et temporelle pour le traitement de la fibromyalgie et de la douleur chronique.

Silo Pharma (SILO) gab positive Ergebnisse von Sterilisations- und Lösungsversuchen seines mit Ketamin beladenen SP-26 Implantats für Fibromyalgie und chronische Schmerzen bekannt. Die Tests, die im Rahmen einer Entwicklungsvereinbarung mit Sever Pharma Solutions durchgeführt wurden, zeigten, dass das Implantat über 80% Arzneimittelfreisetzung innerhalb von 7 Tagen mit gleichmäßiger Abgabe erreichte. Die Implantate zeigten minimale Abweichungen in den physikalischen Eigenschaften, was auf Sicherheit und Stabilität hinweist. Das Unternehmen plant, Tierstudien durchzuführen, um die Wirksamkeit dieser dosiskontrollierten, zeitgesteuerten Implantate zur Behandlung von Fibromyalgie und chronischen Schmerzen zu bewerten.

Positive
  • Successful demonstration of 80%+ drug release over 7 days
  • Consistent drug delivery performance achieved
  • Minimal variation in physical properties confirming stability
  • Advancement to animal studies phase
Negative
  • None.

Insights

The SP-26 ketamine implant testing results reveal promising technical achievements in drug delivery system development. The 80%+ drug release over 7 days demonstrates consistent therapeutic delivery, a important factor for chronic pain management. The stability in physical properties post-sterilization indicates robust manufacturing potential and shelf-life stability.

While these preliminary results are encouraging from a technical standpoint, several critical milestones remain before commercial viability. The upcoming animal studies will need to demonstrate both safety and efficacy in vivo. The ketamine implant's controlled release profile could potentially address key challenges in current fibromyalgia treatments, particularly regarding dosing consistency and patient compliance.

For a micro-cap company ($5.1M), achieving these technical benchmarks is significant, though considerable regulatory hurdles and clinical trials lie ahead. The market opportunity in fibromyalgia treatment is substantial, but success will depend on forthcoming efficacy data and regulatory pathway clarity.

The implant demonstrates stability and consistent drug release, supporting further analytical testing and development

SARASOTA, FL, Oct. 31, 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 promising results from recent sterilization and dissolution tests of its SP-26 ketamine-loaded implant for fibromyalgia and chronic pain. These tests were conducted under the Company’s current development agreement with Sever Pharma Solutions.

Previously, Silo disclosed that Sever Pharma Solutions initiated the scale-up, extrusion, and analytical testing of the SP-26 ketamine hydrochloride (ketamine HCL) polymer implants. This sterilization and dissolution testing utilized the time-released, dose-controlled formulation chosen by Silo for ongoing preclinical research. The analysis of the implants thus far has demonstrated a sustained 80%+ drug release over a 7-day period, highlighting consistent drug delivery. Additionally, the implants showed minimal variation in key physical properties, underscoring the safety and stability of the formulation.

“We believe that these interim results from our SP-26 testing indicate strong drug stability and a reliable release profile, which in our opinion are critical for delivering consistent therapeutic benefits to patients,” said Silo CEO Eric Weisblum. “Our planned upcoming animal studies are expected to focus on assessing the efficacy of these dose-controlled, time-release implants as a potential treatment option for fibromyalgia and chronic pain relief.”

About SPC-15
SPC-15 is a novel serotonin 4 (5-HT4) receptor agonist that utilizes biomarkers for the treatment of PTSD, anxiety, and other stress-induced affective disorders. SPC-15 is being developed as an intranasal medication. If clinically successful, SPC-15 could qualify for the FDA’s streamlined 505(b)(2) regulatory pathway for drug approval. Silo Pharma is conducting preclinical studies of SPC-15 in collaboration with Columbia University and was granted an exclusive license to further develop, manufacture, and commercialize SPC-15 worldwide.
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 , 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 were the results of Silo Pharma's (SILO) SP-26 ketamine implant testing in October 2024?

The testing showed over 80% drug release over a 7-day period with consistent delivery and minimal variation in physical properties, demonstrating stability and safety of the formulation.

What is the purpose of Silo Pharma's (SILO) SP-26 ketamine implant?

The SP-26 ketamine implant is being developed as a potential treatment option for fibromyalgia and chronic pain, utilizing a time-released, dose-controlled formulation.

What are the next steps for Silo Pharma's (SILO) SP-26 ketamine implant development?

The company plans to proceed with animal studies to evaluate the efficacy of the dose-controlled, time-release implants for fibromyalgia and chronic pain relief.

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