Silo Pharma Partners with Resyca for IND-Supporting Intranasal Drug-Device Study of PTSD Drug SPC-15
Silo Pharma (NASDAQ: SILO) has partnered with medical technology provider Resyca BV for a drug-device study of SPC-15, its lead asset for post-traumatic stress disorder (PTSD) treatment. The study will focus on the formulation-specific microchip-based nasal spray system used to deliver the drug.
The intranasal delivery system is designed to bypass the blood-brain barrier, potentially enabling faster therapeutic benefits with optimized safety. This study is expected to provide the final device data and documentation needed for the company's planned FDA IND submission in 2025.
Additionally, Silo is conducting two other SPC-15 studies: an IND-enabling GLP-compliant toxicology and toxicokinetics study, and an FDA-requested 7-day safety and toxicology large animal study.
Silo Pharma (NASDAQ: SILO) ha stretto una collaborazione con il fornitore di tecnologia medica Resyca BV per uno studio su un dispositivo farmaceutico relativo a SPC-15, il suo principale farmaco per il trattamento del disturbo da stress post-traumatico (PTSD). Lo studio si concentrerà sul sistema spray nasale a microchip specifico per la formulazione utilizzato per somministrare il farmaco.
Il sistema di somministrazione intranasale è progettato per superare la barriera emato-encefalica, potenzialmente consentendo benefici terapeutici più rapidi con una sicurezza ottimizzata. Questo studio dovrebbe fornire i dati finali sul dispositivo e la documentazione necessaria per la prevista presentazione IND alla FDA nel 2025.
Inoltre, Silo sta conducendo altri due studi su SPC-15: uno studio tossicologico e tossicocinetico conforme alle normative GLP per l'abilitazione IND, e uno studio di sicurezza e tossicologia su animali di grandi dimensioni richiesto dalla FDA della durata di 7 giorni.
Silo Pharma (NASDAQ: SILO) se ha asociado con el proveedor de tecnología médica Resyca BV para un estudio de dispositivo-medicamento de SPC-15, su principal activo para el tratamiento del trastorno de estrés postraumático (TEPT). El estudio se centrará en el sistema de spray nasal basado en microchip específico para la formulación utilizado para administrar el medicamento.
El sistema de administración intranasal está diseñado para superar la barrera hematoencefálica, lo que podría permitir beneficios terapéuticos más rápidos con una seguridad optimizada. Se espera que este estudio proporcione los datos finales del dispositivo y la documentación necesaria para la presentación IND planificada de la compañía ante la FDA en 2025.
Además, Silo está llevando a cabo otros dos estudios de SPC-15: un estudio toxicológico y toxicocinético conforme a GLP para habilitar el IND, y un estudio de seguridad y toxicología en animales grandes de 7 días solicitado por la FDA.
Silo Pharma (NASDAQ: SILO)는 의료 기술 제공업체 Resyca BV와 협력하여 PTSD(외상 후 스트레스 장애) 치료를 위한 주력 자산인 SPC-15의 약물-기기 연구를 진행하고 있습니다. 이 연구는 약물을 전달하는 데 사용되는 제형 특화 마이크로칩 기반 비강 스프레이 시스템에 중점을 둡니다.
비강 내 투여 시스템은 혈액-뇌 장벽을 우회하도록 설계되어 치료 효과를 더 빠르게 제공하고 안전성을 최적화할 수 있습니다. 이 연구는 2025년 회사가 계획 중인 FDA IND 제출에 필요한 최종 기기 데이터와 문서를 제공할 것으로 예상됩니다.
또한, Silo는 SPC-15에 대해 두 가지 추가 연구를 수행 중입니다: IND 승인용 GLP 준수 독성 및 독성동태학 연구와 FDA 요청에 따른 7일간의 대형 동물 안전성 및 독성 연구입니다.
Silo Pharma (NASDAQ : SILO) s'est associé au fournisseur de technologie médicale Resyca BV pour une étude combinant médicament et dispositif sur SPC-15, son principal actif pour le traitement du trouble de stress post-traumatique (TSPT). L'étude portera sur le système de spray nasal à micro-puce spécifique à la formulation utilisé pour administrer le médicament.
Le système d'administration intranasale est conçu pour contourner la barrière hémato-encéphalique, permettant potentiellement des bénéfices thérapeutiques plus rapides avec une sécurité optimisée. Cette étude devrait fournir les données finales sur le dispositif ainsi que la documentation nécessaire pour la soumission IND prévue par la société à la FDA en 2025.
De plus, Silo mène deux autres études sur SPC-15 : une étude toxicologique et toxicocinétique conforme aux normes GLP pour l'obtention de l'IND, ainsi qu'une étude de sécurité et toxicologie sur animaux de grande taille de 7 jours demandée par la FDA.
Silo Pharma (NASDAQ: SILO) hat eine Partnerschaft mit dem Medizintechnikanbieter Resyca BV für eine Arzneimittel-Geräte-Studie zu SPC-15, dem führenden Wirkstoff zur Behandlung von posttraumatischer Belastungsstörung (PTBS), geschlossen. Die Studie konzentriert sich auf das formulationsspezifische mikrochipbasierte nasale Sprühsystem zur Verabreichung des Medikaments.
Das intranasale Abgabesystem ist darauf ausgelegt, die Blut-Hirn-Schranke zu umgehen, was potenziell schnellere therapeutische Vorteile bei optimierter Sicherheit ermöglicht. Diese Studie soll die abschließenden Gerätedaten und Dokumentationen liefern, die für die geplante FDA IND-Einreichung des Unternehmens im Jahr 2025 erforderlich sind.
Darüber hinaus führt Silo zwei weitere SPC-15-Studien durch: eine GLP-konforme Toxikologie- und Toxikokinetikstudie zur IND-Freigabe sowie eine von der FDA geforderte 7-tägige Sicherheits- und Toxikologiestudie an Großtieren.
- Partnership with Resyca BV advances development of innovative drug delivery system
- Direct-to-brain delivery system potentially offers faster therapeutic benefits
- Company progressing towards FDA IND submission in 2025
- Multiple concurrent studies demonstrate advancement in drug development pipeline
- Still in early developmental stage with no FDA approval yet
- Additional studies and regulatory approvals required before commercialization
Study is expected to deliver final device data and documentation needed for planned FDA IND submission
SARASOTA, FL, May 21, 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 that it has entered into a service agreement with medical technology provider Resyca BV for a drug-device study of the formulation-specific microchip-based nasal spray system used in its lead asset SPC-15, an intranasal prophylactic treatment for post-traumatic stress disorder (PTSD).
“This study is expected to provide the final necessary device data and documentation for SPC-15’s IND, which we plan to submit to the FDA this year,” said Eric Weisblum, CEO of Silo. “Our chosen device transports the molecules to the brain directly, bypassing the blood-brain barrier, to increase drug concentration. We believe this method can drive faster onset of therapeutic benefit with optimized safety for the treatment of PTSD patients.”
The Company is currently conducting two additional SPC-15 studies: an IND-enabling GLP (Good Laboratory Practice)-compliant toxicology and toxicokinetics study, and an FDA requested 7-day safety and toxicology large animal study.
About SPC-15
SPC-15 is an intranasal serotonin 5-HT4 receptor agonist aimed at treating stress-induced psychiatric disorders such as PTSD and anxiety. With its potential eligibility for the FDA’s streamlined 505(b)(2) regulatory pathway, SPC-15 offers a promising approach to accelerate the approval process. Silo Pharma is collaborating with Columbia University to conduct preclinical studies and has exclusive global rights to the development and commercialization of SPC-15.
About Resyca
Resyca BV was founded in 2020 and is a joint venture between Bespak Limited and Medspray Pharma BV. Resyca BV specializes in the development and manufacturing of compact, user-friendly soft mist inhalation and soft nasal spray devices, incorporating the proprietary Medspray micro-nozzle technology. These devices are tailored for pulmonary and nasal applications, utilising standard pre-filled syringes / primary packaging and filling lines. As the soft mist development centre within Bespak, Resyca offers comprehensive services spanning from early-stage development through to commercial production, inclusive of filling, labelling, and packaging.
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 the Company’s ability to successfully complete its preclinical studies and generate positive data, the risk that the FDA may not accept or may require changes to the IND, or may not allow the Company to proceed with clinical trials, the risk that the FDA may not approve SPC-15 on the Company’s expected timeline, or at all, 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
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FAQ
What is the purpose of Silo Pharma's partnership with Resyca BV for SPC-15?
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