Silo Pharma Announces Completion of Dosing in Safety Study of PTSD Drug SPC-15
Silo Pharma (Nasdaq: SILO) has completed dosing in a FDA-requested 7-day safety and toxicology large animal study for its lead PTSD drug candidate SPC-15. The bioanalytical and safety/toxicology results are expected within 60 days.
The company is progressing with two remaining preclinical studies: an IND-enabling GLP-compliant toxicology study and a device study for SPC-15's microchip-based nasal spray system. Silo plans to pursue the FDA's 505(b)(2) regulatory pathway for SPC-15's approval, which could potentially accelerate clinical timelines and reduce development costs.
Silo Pharma (Nasdaq: SILO) ha completato la somministrazione in uno studio su animali di grandi dimensioni, richiesto dalla FDA, della durata di 7 giorni per valutare la sicurezza e la tossicologia del suo principale candidato farmaco per il disturbo da stress post-traumatico, SPC-15. I risultati bioanalitici e di sicurezza/tossicologia sono attesi entro 60 giorni.
L'azienda sta proseguendo con due studi preclinici rimanenti: uno studio tossicologico conforme alle norme GLP e abilitante per l'IND e uno studio sul dispositivo per il sistema spray nasale basato su microchip di SPC-15. Silo intende seguire la via regolatoria 505(b)(2) della FDA per l'approvazione di SPC-15, che potrebbe accelerare i tempi clinici e ridurre i costi di sviluppo.
Silo Pharma (Nasdaq: SILO) ha completado la dosificación en un estudio de seguridad y toxicología en animales grandes de 7 días solicitado por la FDA para su principal candidato a fármaco para el TEPT, SPC-15. Se esperan los resultados bioanalíticos y de seguridad/toxicología en un plazo de 60 días.
La compañía continúa con dos estudios preclínicos pendientes: un estudio toxicológico conforme a GLP para habilitar el IND y un estudio del dispositivo para el sistema de spray nasal basado en microchip de SPC-15. Silo planea seguir la vía regulatoria 505(b)(2) de la FDA para la aprobación de SPC-15, lo que podría acelerar los tiempos clínicos y reducir los costos de desarrollo.
Silo Pharma (나스닥: SILO)는 FDA 요청에 따라 7일간 실시된 주요 PTSD 치료 후보 약물 SPC-15의 대형 동물 안전성 및 독성학 연구 투여를 완료했습니다. 생물분석 및 안전성/독성 결과는 60일 이내에 나올 예정입니다.
회사는 SPC-15의 마이크로칩 기반 비강 스프레이 시스템에 대한 IND 승인용 GLP 준수 독성학 연구와 기기 연구 등 두 가지 남은 전임상 연구를 진행 중입니다. Silo는 SPC-15 승인에 대해 FDA의 505(b)(2) 규제 경로를 추구할 계획이며, 이는 임상 일정 단축과 개발 비용 절감에 기여할 수 있습니다.
Silo Pharma (Nasdaq : SILO) a terminé l'administration dans une étude de sécurité et de toxicologie sur animaux de grande taille, d'une durée de 7 jours, demandée par la FDA pour son principal candidat médicament contre le SSPT, SPC-15. Les résultats bioanalytiques et de sécurité/toxicologie sont attendus sous 60 jours.
L'entreprise progresse avec deux études précliniques restantes : une étude toxicologique conforme aux GLP pour l'autorisation IND et une étude sur le dispositif pour le système de spray nasal à micro-puce de SPC-15. Silo prévoit de suivre la voie réglementaire 505(b)(2) de la FDA pour l'approbation de SPC-15, ce qui pourrait potentiellement accélérer les délais cliniques et réduire les coûts de développement.
Silo Pharma (Nasdaq: SILO) hat die Dosierung in einer von der FDA angeforderten 7-tägigen Sicherheits- und Toxikologiestudie an Großtieren für seinen führenden PTSD-Arzneimittelkandidaten SPC-15 abgeschlossen. Die bioanalytischen sowie Sicherheits- und Toxikologieergebnisse werden innerhalb von 60 Tagen erwartet.
Das Unternehmen arbeitet an zwei verbleibenden präklinischen Studien: einer GLP-konformen, IND-ermöglichenden Toxikologiestudie und einer Gerätestudie für das mikrochipbasierte Nasenspray-System von SPC-15. Silo plant, den 505(b)(2)-Regulierungsweg der FDA für die Zulassung von SPC-15 zu verfolgen, was die klinischen Zeitpläne beschleunigen und die Entwicklungskosten senken könnte.
- Completion of FDA-requested safety and toxicology study for SPC-15
- Previous strong safety and therapeutic delivery results for SPC-15
- Pursuing 505(b)(2) pathway could reduce development time and costs
- Two additional preclinical studies still required before IND submission
- Final safety/toxicology results pending for 60 days
SARASOTA, FL, July 16, 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 completion of dosing in a U.S. Food and Drug Administration (FDA)-requested 7-day safety and toxicology large animal study of its lead asset SPC-15, and bioanalytical and safety/toxicology results for such study are expected within 60 days.
“Our novel PTSD drug candidate SPC-15 has already shown strong safety and therapeutic delivery, and we are confident about the final data results from our preclinical discovery program,” said Eric Weisblum, CEO of Silo. “We remain on track to conclude our two remaining final preclinical studies and planning to submit an investigational new drug (IND) application for SPC-15.”
Two remaining SPC-15 studies are currently in progress or being planned: an IND-enabling GLP (Good Laboratory Practice)-compliant toxicology and toxicokinetic animal study, and a device study of SPC-15’s formulation-specific microchip-based nasal spray system.
Silo plans to seek the FDA’s 505(b)(2) regulatory pathway for approval of SPC-15, a drug development route that can significantly shorten clinical timelines for FDA approval and reduce drug development costs.
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 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
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FAQ
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