Silo Pharma Achieves Key Milestone with First Dosing in IND-Enabling GLP Study for SPC-15 as a Groundbreaking PTSD Treatment
Silo Pharma (Nasdaq: SILO) has announced a significant milestone in the development of its lead asset SPC-15, an intranasal prophylactic treatment for post-traumatic stress disorder (PTSD). The company has initiated first dosing in an IND-enabling GLP-compliant toxicology and toxicokinetics study.
Following a successful pre-IND meeting with the FDA in September 2024, Silo is pursuing the 505(b)(2) regulatory pathway for SPC-15's approval. This pathway is designed to potentially reduce clinical development timelines and costs. The current studies, if successful, will provide the final preclinical data required for submitting an IND application and advancing to first-in-human clinical trials.
Silo Pharma (Nasdaq: SILO) ha annunciato un traguardo significativo nello sviluppo del suo principale asset SPC-15, un trattamento intranasale profilattico per il disturbo da stress post-traumatico (PTSD). L'azienda ha avviato la prima somministrazione in uno studio di tossicologia e tossicocinetica conforme GLP abilitante per l'IND.
Dopo un incontro pre-IND di successo con la FDA nel settembre 2024, Silo sta perseguendo il percorso normativo 505(b)(2) per l'approvazione di SPC-15. Questo percorso è progettato per ridurre potenzialmente i tempi e i costi dello sviluppo clinico. Gli studi attuali, se avranno successo, forniranno i dati preclinici finali necessari per presentare una domanda IND e avanzare verso i trial clinici di prima in umani.
Silo Pharma (Nasdaq: SILO) ha anunciado un hito significativo en el desarrollo de su activo principal SPC-15, un tratamiento profiláctico intranasal para el trastorno de estrés postraumático (TEPT). La compañía ha iniciado la primera dosificación en un estudio de toxicología y toxicocinética conforme a GLP que habilita el IND.
Tras una reunión pre-IND exitosa con la FDA en septiembre de 2024, Silo está persiguiendo la ruta regulatoria 505(b)(2) para la aprobación de SPC-15. Esta ruta está diseñada para reducir potencialmente los plazos y costos del desarrollo clínico. Los estudios actuales, si tienen éxito, proporcionarán los datos preclínicos finales necesarios para presentar una solicitud IND y avanzar a ensayos clínicos en humanos.
사일로 파마(Silo Pharma) (Nasdaq: SILO)는 주요 자산 SPC-15의 개발에서 중요한 이정표를 발표했습니다. 이는 외상 후 스트레스 장애(PTSD)에 대한 비강 내 예방 치료제입니다. 이 회사는 IND를 위한 GLP 준수 독성학 및 독성약리학 연구에서 첫 번째 투여를 시작했습니다.
2024년 9월 FDA와의 성공적인 사전 IND 회의 후, 사일로는 SPC-15의 승인을 위한 505(b)(2) 규제 경로를 추구하고 있습니다. 이 경로는 임상 개발 일정과 비용을 줄일 수 있도록 설계되었습니다. 현재 진행 중인 연구가 성공하면 IND 신청을 제출하고 인간 대상의 임상 시험으로 나아가는 데 필요한 최종 전임상 데이터를 제공할 것입니다.
Silo Pharma (Nasdaq: SILO) a annoncé une étape importante dans le développement de son actif principal SPC-15, un traitement prophylactique intranasal pour le trouble de stress post-traumatique (TSPT). L'entreprise a lancé la première dose dans une étude de toxicologie et de toxicocinétique conforme aux GLP, permettant l'IND.
Suite à une réunion pré-IND réussie avec la FDA en septembre 2024, Silo poursuit le chemin réglementaire 505(b)(2) pour l'approbation de SPC-15. Ce chemin est conçu pour réduire potentiellement les délais et les coûts de développement clinique. Les études actuelles, si elles réussissent, fourniront les données précliniques finales nécessaires pour soumettre une demande IND et avancer vers les essais cliniques chez l'homme.
Silo Pharma (Nasdaq: SILO) hat einen bedeutenden Meilenstein in der Entwicklung seines Hauptprodukts SPC-15 bekannt gegeben, einer intranasalen prophylaktischen Behandlung für posttraumatische Belastungsstörung (PTBS). Das Unternehmen hat die erste Dosierung in einer IND-erlaubenden GLP-konformen Toxikologie- und Toxikokinetikstudie eingeleitet.
Nach einem erfolgreichen Pre-IND-Meeting mit der FDA im September 2024 verfolgt Silo den 505(b)(2) regulatorischen Weg zur Genehmigung von SPC-15. Dieser Weg soll potenziell die klinischen Entwicklungszeiten und -kosten reduzieren. Die aktuellen Studien werden, sofern erfolgreich, die endgültigen präklinischen Daten liefern, die für die Einreichung eines IND-Antrags und den Übergang zu den ersten klinischen Studien am Menschen erforderlich sind.
- Achieved first dosing milestone in IND-enabling GLP study
- FDA provided clear regulatory pathway through 505(b)(2) route
- Potential for shortened development timeline and reduced costs through 505(b)(2) pathway
- Still in preclinical phase with no human trial data yet
- Success of current studies required before IND submission
Preclinical Data to Support Advancement Toward First-in-Human Clinical Trials
SARASOTA, FL, March 26, 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 first dosing in an investigational new drug (IND)-enabling GLP (Good Laboratory Practice)-compliant toxicology and toxicokinetics study of its lead asset, SPC-15, an intranasal prophylactic treatment for post-traumatic stress disorder (PTSD).
“This IND-enabling safety study and our concurrent GLP-compliant pharmacokinetic and pharmacodynamic study, if successful, will provide the last preclinical data needed to open an IND for SPC-15,” said Eric Weisblum, CEO of Silo. “We are following the FDA’s helpful responses to our pre-IND submission, which provide a clear path to an IND submission to first-in-human clinical studies.”
Silo Pharma completed a pre-IND meeting in September 2024 to align with the FDA on the 505(b)(2) regulatory pathway for approval of SPC-15 and review the Company’s proposed plan to support opening an IND. The FDA’s 505(b)(2) drug development route 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
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.
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FAQ
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