Silo Pharma Expands Development Agreement with Sever Pharma for Novel Ketamine Implant Therapeutic
Silo Pharma (NASDAQ: SILO) has expanded its development agreement with Sever Pharma Solutions for its novel ketamine-based injectable implant, SP-26, targeting chronic pain and fibromyalgia. The collaboration aims to scale-up extrusion processes and continue analytical testing for this non-opioid treatment. SP-26 is a dissolvable ketamine-loaded implant designed for time-released, dose-controlled delivery.
CEO Eric Weisblum expressed satisfaction with the ongoing partnership, highlighting that Sever Pharma has been instrumental in earlier production and delivery system validation. This expanded agreement is expected to bring Silo closer to selecting the optimal final dosage and formulation for animal studies. If clinically successful, SP-26 could potentially qualify for the FDA's streamlined 505(b)(2) regulatory pathway for drug approval, potentially expediting its market entry.
Silo Pharma (NASDAQ: SILO) ha ampliato il suo accordo di sviluppo con Sever Pharma Solutions per il suo innovativo impianto iniettabile a base di ketamina, SP-26, mirato al dolore cronico e alla fibromialgia. La collaborazione mira a ottimizzare i processi di estrusione e proseguire i test analitici per questo trattamento non oppioide. SP-26 è un impianto dissolvibile caricato di ketamina progettato per una somministrazione a rilascio controllato nel tempo.
Il CEO Eric Weisblum ha espresso soddisfazione per la collaborazione in corso, sottolineando che Sever Pharma è stata fondamentale nella validazione della produzione e del sistema di consegna. Questo accordo ampliato dovrebbe avvicinare Silo a selezionare il dosaggio finale ottimale e la formulazione per gli studi sugli animali. Se clinicamente efficace, SP-26 potrebbe potenzialmente qualificarsi per il percorso normativo semplificato 505(b)(2) della FDA per l'approvazione dei farmaci, accelerando la sua entrata nel mercato.
Silo Pharma (NASDAQ: SILO) ha ampliado su acuerdo de desarrollo con Sever Pharma Solutions para su novedoso implante inyectable a base de ketamina, SP-26, dirigido al dolor crónico y la fibromialgia. La colaboración tiene como objetivo escalar los procesos de extrusión y continuar las pruebas analíticas para este tratamiento no opioide. SP-26 es un implante disoluble cargado de ketamina diseñado para una entrega controlada y liberada en el tiempo.
El CEO Eric Weisblum expresó su satisfacción con la asociación en curso, destacando que Sever Pharma ha sido fundamental en la validación del sistema de producción y entrega anterior. Este acuerdo ampliado se espera que acerque a Silo a seleccionar la dosis y formulación final óptima para estudios en animales. Si tiene éxito clínicamente, SP-26 podría calificar potencialmente para el camino regulatorio simplificado 505(b)(2) de la FDA para la aprobación de medicamentos, acelerando posiblemente su entrada al mercado.
사일로 파마(Silo Pharma)(NASDAQ: SILO)는 만성 통증 및 섬유근육통을 타겟으로 하는 새로운 케타민 기반 주입 임플란트 SP-26에 대해 Sever Pharma Solutions와의 개발 계약을 확대했습니다. 이 협력의 목표는 압출 프로세스를 확장하고 분석 테스트를 계속하는 것입니다. SP-26은 시간 제어 방출을 위해 설계된 용해 가능한 케타민 로드 임플란트입니다.
CEO 에릭 바이스블럼(Eric Weisblum)은 진행 중인 파트너십에 대한 만족감을 표하며, Sever Pharma가 이전 생산 및 전달 시스템 검증에 중요한 역할을 했다고 강조했습니다. 이 확대된 계약은 Silo가 동물 연구를 위한 최적의 최종 용량 및 제형을 선택하는 것에 더 가까워지도록 할 것으로 예상됩니다. 임상적으로 성공할 경우, SP-26은 약물 승인을 위한 FDA의 간소화된 505(b)(2) 규제 경로에 적격할 수 있어 시장 진입 속도를 높일 수 있습니다.
Silo Pharma (NASDAQ: SILO) a élargi son accord de développement avec Sever Pharma Solutions pour son implant injectable à base de kétamine, SP-26, visant la douleur chronique et la fibromyalgie. La collaboration vise à étendre les processus d'extrusion et à poursuivre les tests analytiques pour ce traitement non opioïde. SP-26 est un implant soluble chargé de kétamine conçu pour une libération contrôlée dans le temps.
Le PDG Eric Weisblum a exprimé sa satisfaction quant au partenariat en cours, soulignant que Sever Pharma a été essentiel dans la validation des systèmes de production et de livraison antérieurs. Cet accord élargi devrait rapprocher Silo de la sélection de la posologie et de la formulation finale optimales pour les études sur les animaux. Si le traitement est cliniquement réussi, SP-26 pourrait potentiellement se qualifier pour le chemin réglementaire simplifié 505(b)(2) de la FDA pour l'approbation des médicaments, accélérant ainsi son entrée sur le marché.
Silo Pharma (NASDAQ: SILO) hat seine Entwicklungsvereinbarung mit Sever Pharma Solutions für sein neuartiges ketaminbasiertes injizierbares Implantat SP-26, das auf chronische Schmerzen und Fibromyalgie abzielt, ausgeweitet. Die Zusammenarbeit zielt darauf ab, Extrusionsprozesse zu skalieren und analytische Tests fortzusetzen für diese nicht-opioide Behandlung. SP-26 ist ein lösliches ketaminbeladenes Implantat, das für eine zeitgesteuerte, dosierte Abgabe entwickelt wurde.
CEO Eric Weisblum äußerte sich zufrieden über die laufende Partnerschaft und betonte, dass Sever Pharma bei der Validierung des Produktions- und Liefersystems eine entscheidende Rolle gespielt hat. Diese erweiterte Vereinbarung wird voraussichtlich Silo näher bringen, die optimale endgültige Dosierung und Formulierung auszuwählen für Tierversuche. Wenn klinisch erfolgreich, könnte SP-26 potenziell für den vereinfachten 505(b)(2) Regulierungsweg der FDA zur Arzneimittelzulassung in Frage kommen, was möglicherweise den Markteintritt beschleunigt.
- Expansion of development agreement with Sever Pharma for SP-26 ketamine implant
- Potential for streamlined FDA 505(b)(2) regulatory pathway if clinically successful
- Progress towards optimal dosage and formulation selection for animal studies
- SP-26 is still in pre-clinical testing phase, indicating a long path to potential market approval
- No guarantee of clinical success or FDA approval
Insights
The expansion of Silo Pharma's development agreement with Sever Pharma for the SP-26 ketamine implant is a significant step forward in addressing chronic pain and fibromyalgia. This novel approach using a dissolvable, injectable implant could revolutionize pain management by providing a controlled-release, non-opioid alternative.
The focus on scale-up extrusion and continued analytical testing indicates progress towards optimizing the formulation for pre-clinical studies. This methodical approach enhances the likelihood of developing a viable therapeutic. The potential for the FDA's 505(b)(2) pathway could accelerate the approval process, potentially bringing this innovative treatment to market faster.
However, investors should note that success in pre-clinical stages doesn't guarantee clinical efficacy or regulatory approval. The chronic pain market is highly competitive and the unique delivery system will need to demonstrate clear advantages over existing treatments to gain market share.
Silo Pharma's expanded agreement with Sever Pharma represents a positive development for the company's pipeline. The focus on SP-26, a novel ketamine-based implant for chronic pain and fibromyalgia, targets a substantial market opportunity. The global chronic pain treatment market was valued at
The potential use of the FDA's 505(b)(2) pathway could lead to faster approval and reduced development costs, which is financially advantageous for a developmental stage company like Silo. However, investors should be aware that the company is still in early stages, with no guarantee of successful clinical trials or eventual market approval.
While this news doesn't provide immediate financial impact, it demonstrates progress in Silo's development pipeline, which could positively influence investor sentiment and potentially support the company's valuation in the medium to long term.
SP-26 dissolvable ketamine-based injectable implant targets chronic pain and fibromyalgia
Sever Pharma to scale-up extrusion processes and continue analytical testing for novel non-opioid treatment
SARASOTA, FL, Aug. 14, 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 new agreement with Sever Pharma Solutions for scale-up extrusion of the Company’s SP-26 ketamine-loaded implant therapeutic targeting fibromyalgia and chronic pain. In addition, Sever Pharma Solutions will continue with analytical testing of the ketamine hydrochloride (ketamine HCL) polymer implants using the optimal time-released, dose-controlled formulation previously selected by Silo for continuing pre-clinical studies.
“Sever Pharma Solutions has been our partner for earlier production of the ketamine implants and validation of the delivery system through successful assay testing,” said Silo CEO Eric Weisblum. “We are pleased to continue our collaboration as we move forward with further pre-clinical testing of our novel non-opioid chronic pain therapeutic. This process is expected to bring Silo closer to selecting the optimal final dosage and formulation in SP-26 to be utilized in animal studies
If clinically successful, SP-26 could qualify for the FDA’s streamlined 505(b)(2) regulatory pathway for drug approval.
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.
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.
Contact
800-705-0120
investors@silopharma.com
FAQ
What is Silo Pharma's SP-26 and what is it designed to treat?
What is the recent development in Silo Pharma's agreement with Sever Pharma?
What potential regulatory pathway could SP-26 qualify for if clinically successful?
What is the current development stage of Silo Pharma's SP-26 implant?
