Silo Pharma Advances PTSD Drug SPC-15 Toward First-in-Human Trial with Key Safety Study Initiated at Frontage Laboratories
Silo Pharma (NASDAQ: SILO) has initiated a crucial 7-day safety and toxicology study for its lead drug candidate SPC-15, an intranasal PTSD treatment, at Frontage Laboratories. The study aims to gather additional data for the company's upcoming FDA investigational new drug (IND) application. Silo is simultaneously conducting a separate IND-enabling GLP-compliant toxicology study.
The company plans to submit its IND application in 2025, and upon approval, will proceed with a first-in-human Phase 1 clinical trial. SPC-15's development is backed by an exclusive global license from Columbia University for worldwide development, manufacturing, and commercialization rights.
Silo Pharma (NASDAQ: SILO) ha avviato uno studio fondamentale di sicurezza e tossicologia della durata di 7 giorni per il suo principale candidato farmaco, SPC-15, un trattamento intranasale per il disturbo da stress post-traumatico (PTSD), presso Frontage Laboratories. Lo studio mira a raccogliere ulteriori dati per la prossima domanda di nuovo farmaco sperimentale (IND) che l'azienda presenterà alla FDA. Contemporaneamente, Silo sta conducendo un altro studio tossicologico conforme alle normative GLP per l'abilitazione all'IND.
L'azienda prevede di presentare la domanda IND nel 2025 e, una volta approvata, procederà con una sperimentazione clinica di Fase 1 sull'uomo. Lo sviluppo di SPC-15 è supportato da una licenza globale esclusiva concessa dalla Columbia University, che copre i diritti mondiali di sviluppo, produzione e commercializzazione.
Silo Pharma (NASDAQ: SILO) ha iniciado un estudio crucial de seguridad y toxicología de 7 días para su principal candidato a medicamento, SPC-15, un tratamiento intranasal para el trastorno de estrés postraumático (TEPT), en Frontage Laboratories. El estudio tiene como objetivo recopilar datos adicionales para la próxima solicitud de nuevo fármaco en investigación (IND) ante la FDA. Simultáneamente, Silo está realizando otro estudio toxicológico conforme a GLP para habilitar el IND.
La compañía planea presentar la solicitud IND en 2025 y, tras su aprobación, procederá con un ensayo clínico de Fase 1 en humanos. El desarrollo de SPC-15 cuenta con una licencia global exclusiva de la Universidad de Columbia para los derechos mundiales de desarrollo, fabricación y comercialización.
Silo Pharma (NASDAQ: SILO)는 주요 약물 후보인 SPC-15의 7일간 안전성 및 독성 연구를 Frontage Laboratories에서 시작했습니다. SPC-15는 비강 투여 PTSD 치료제로, 이번 연구는 회사의 FDA 임상시험 승인(IND) 신청을 위한 추가 데이터를 수집하는 것을 목표로 합니다. 동시에 Silo는 별도의 GLP 준수 독성 연구도 진행 중입니다.
회사는 2025년에 IND 신청을 제출할 계획이며, 승인 시 최초 인간 대상 1상 임상시험을 진행할 예정입니다. SPC-15 개발은 컬럼비아 대학교로부터 전 세계 개발, 제조 및 상업화 권리를 독점적으로 허가받아 지원받고 있습니다.
Silo Pharma (NASDAQ : SILO) a lancé une étude cruciale de sécurité et de toxicologie de 7 jours pour son principal candidat médicament, SPC-15, un traitement intranasal du trouble de stress post-traumatique (TSPT), chez Frontage Laboratories. Cette étude vise à recueillir des données supplémentaires pour la prochaine demande d’autorisation de nouveau médicament expérimental (IND) auprès de la FDA. Parallèlement, Silo mène une autre étude toxicologique conforme aux bonnes pratiques de laboratoire (GLP) pour l’obtention de l’IND.
L’entreprise prévoit de soumettre sa demande IND en 2025 et, après approbation, de lancer un essai clinique de phase 1 chez l’humain. Le développement de SPC-15 bénéficie d’une licence mondiale exclusive de l’Université de Columbia pour les droits mondiaux de développement, de fabrication et de commercialisation.
Silo Pharma (NASDAQ: SILO) hat eine wichtige siebentägige Sicherheits- und Toxikologiestudie für seinen führenden Arzneimittelkandidaten SPC-15, eine intranasale Behandlung für PTBS, bei Frontage Laboratories gestartet. Die Studie soll zusätzliche Daten für den bevorstehenden Antrag des Unternehmens auf eine FDA-Zulassung für ein klinisches Prüfpräparat (IND) liefern. Gleichzeitig führt Silo eine weitere GLP-konforme Toxikologiestudie zur IND-Freigabe durch.
Das Unternehmen plant, den IND-Antrag im Jahr 2025 einzureichen und nach Genehmigung mit einer Phase-1-Studie am Menschen zu beginnen. Die Entwicklung von SPC-15 wird durch eine exklusive weltweite Lizenz der Columbia University für Entwicklung, Herstellung und Vermarktung unterstützt.
- None.
- Still in early developmental stage with no human trial data
- Multiple regulatory hurdles remain before potential commercialization
- Timeline uncertainty for FDA approval process
Clear Regulatory Path to Clinical Trials for Intranasal PTSD Therapy Targeting Multi-Billion-Dollar Market
SARASOTA, FL, May 14, 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 an agreement with Frontage Laboratories, a global full-service CRO (contract research organization), for a Food and Drug Administration (FDA) requested 7-day safety and toxicology large animal study of its lead asset SPC-15, an intranasal prophylactic treatment for post-traumatic stress disorder (PTSD).
“We are conducting a 7-day safety and toxicology study to gather additional data that is expected to supplement and reinforce our SPC-15 investigational new drug (IND) application to the FDA,” said Eric Weisblum, CEO of Silo. “We currently remain on track to begin an FDA submission this year.”
The Company is currently working on a separate IND-enabling Good Laboratory Practice (GLP) -compliant toxicology and toxicokinetic study of SPC-15. Positive preclinical data from these studies, if achieved, would support an IND submission for SPC-15 in 2025. Should Silo receive approval of the IND, Silo would proceed to a first-in-human Phase 1 clinical trial for SPC-15.
Columbia University, the Company’s collaboration partner for pre-clinical development, granted Silo an exclusive global license to further develop, manufacture, and commercialize SPC-15 worldwide.
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 Frontage
Frontage Laboratories is a US-based Contract Research Organization (CRO) that was initially established in New Jersey in April 2001 and later relocated to Pennsylvania in 2004. As an FDA-registered and inspected global pharmaceutical development and manufacturing organization, we are headquartered in Exton, PA, with an impressive network of 25 facilities spread across Pennsylvania, New Jersey, Illinois, Ohio, California, Florida, Canada, Italy, and China. We are dedicated to accelerating the development of innovative therapies by providing a broad range of science driven and quality focused services for drug discovery, DMPK, preclinical, formulation development and CTM, Analytical, clinical trials, bioanalytical and commercial-scale manufacturing.
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
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