Silo Pharma Announces Completion of FDA Pre-IND Meeting to Advance Development of SPC-15 for Treatment of PTSD
Silo Pharma (Nasdaq: SILO) has completed a pre-IND meeting with the FDA regarding SPC-15, an intranasal treatment for PTSD and stress-induced anxiety disorder. The company proposed a 505(b)(2) regulatory pathway for approval, which could shorten clinical timelines and reduce development costs. The FDA provided written responses, giving Silo a clear path to advance SPC-15 into human trials.
Silo is currently conducting a GLP-compliant pharmacokinetic and pharmacodynamic study before submitting an IND for a potential first-in-human clinical trial. Pre-clinical data suggests SPC-15 has additive benefits for combating stress-induced pathophysiology. Silo has an exclusive license from Columbia University to develop, manufacture, and commercialize SPC-15 worldwide.
Silo Pharma (Nasdaq: SILO) ha completato un incontro pre-IND con la FDA riguardo SPC-15, un trattamento intranasale per il PTSD e il disturbo d'ansia indotto dallo stress. L'azienda ha proposto un percorso normativo 505(b)(2) per l'approvazione, che potrebbe ridurre i tempi clinici e i costi di sviluppo. La FDA ha fornito risposte scritte, offrendo a Silo un percorso chiaro per avanzare SPC-15 verso le sperimentazioni umane.
Silo sta attualmente conducendo uno studio farmacocinetico e farmacodinamico conforme GLP prima di presentare un'IND per un potenziale trial clinico di prima in umani. I dati pre-clinici suggeriscono che SPC-15 ha benefici additivi nel combattere la fisiopatologia indotta dallo stress. Silo possiede una licenza esclusiva dalla Columbia University per sviluppare, produrre e commercializzare SPC-15 a livello mondiale.
Silo Pharma (Nasdaq: SILO) ha completado una reunión pre-IND con la FDA sobre SPC-15, un tratamiento intranasal para PTSD y trastorno de ansiedad inducido por el estrés. La compañía propuso una vía regulatoria 505(b)(2) para su aprobación, lo que podría acortar los plazos clínicos y reducir los costos de desarrollo. La FDA proporcionó respuestas por escrito, ofreciendo a Silo un camino claro para avanzar SPC-15 a ensayos en humanos.
Silo está realizando actualmente un estudio farmacocinético y farmacodinámico conforme a GLP antes de presentar un IND para un potencial ensayo clínico de primera vez en humanos. Los datos preclínicos sugieren que SPC-15 tiene beneficios aditivos para combatir la fisiopatología inducida por el estrés. Silo tiene una licencia exclusiva de la Universidad de Columbia para desarrollar, fabricar y comercializar SPC-15 en todo el mundo.
سيل로 파마(Silo Pharma)(Nasdaq: SILO)가 PTSD(외상 후 스트레스 장애) 및 스트레스 유발 불안 장애에 대한 비강 내 치료제 SPC-15에 대한 FDA와의 IND 이전 회의를 완료했습니다. 회사는 승인을 위해 505(b)(2) 규제 경로를 제안했으며, 이는 임상 일정 단축 및 개발 비용 절감을 가져올 수 있습니다. FDA는 서면 답변을 제공하여 Silo가 SPC-15를 인체 시험으로 진전시킬 수 있는 명확한 경로를 제시했습니다.
Silo는 현재 GLP 준수 약리학 및 약리작용 연구를 수행하고 있으며, 이를 통해 인간에서의 잠재적 최초 임상 시험을 위한 IND를 제출할 예정입니다. 전임상 데이터는 SPC-15가 스트레스로 인한 병리학적 현상에 대항하는 부가적인 이점을 가지고 있다고 제안합니다. Silo는 SPC-15를 전 세계적으로 개발, 제조 및 상용화할 수 있는 콜롬비아 대학교의 독점 라이센스를 보유하고 있습니다.
Silo Pharma (Nasdaq: SILO) a terminé une réunion pré-IND avec la FDA concernant SPC-15, un traitement intranasal pour le PTSD et le trouble d'anxiété induit par le stress. L'entreprise a proposé un chemin réglementaire 505(b)(2) pour l'approbation, ce qui pourrait raccourcir les délais cliniques et réduire les coûts de développement. La FDA a fourni des réponses écrites, offrant à Silo un chemin clair pour faire avancer SPC-15 dans les essais humains.
Silo mène actuellement une étude pharmacocinétique et pharmacodynamique conforme aux BPL avant de soumettre un IND pour un potentiel essai clinique de première ligne chez l'homme. Les données précliniques suggèrent que SPC-15 a des bénéfices additifs pour lutter contre la physiopathologie induite par le stress. Silo possède une licence exclusive de l'Université de Columbia pour développer, fabriquer et commercialiser SPC-15 dans le monde entier.
Silo Pharma (Nasdaq: SILO) hat ein Pre-IND-Meeting mit der FDA bezüglich SPC-15, einer intranasalen Behandlung für PTSD und stressinduzierte Angststörungen, abgeschlossen. Das Unternehmen schlug einen 505(b)(2) regulativen Weg zur Genehmigung vor, der klinische Zeitpläne verkürzen und Entwicklungskosten senken könnte. Die FDA gab schriftliche Antworten, die Silo einen klaren Weg weisen, SPC-15 in die klinischen Studien zu bringen.
Silo führt derzeit eine GLP-konforme pharmakokinetische und pharmakodynamische Studie durch, bevor es einen IND für eine potenzielle erste klinische Prüfung am Menschen einreicht. Vorläufige Daten deuten darauf hin, dass SPC-15 additive Vorteile zur Bekämpfung von stressinduzierter Pathophysiologie hat. Silo verfügt über eine exklusive Lizenz von der Columbia University zur Entwicklung, Herstellung und Vermarktung von SPC-15 weltweit.
- Completion of FDA pre-IND meeting for SPC-15, potentially expediting the approval process
- Proposed 505(b)(2) regulatory pathway could reduce development time and costs
- Clear path for advancing SPC-15 into human clinical trials
- Ongoing GLP-compliant pharmacokinetic and pharmacodynamic study
- Exclusive worldwide license from Columbia University for SPC-15
- SPC-15 is still in early development stages, with no human trial data available yet
- Potential regulatory hurdles and clinical trial outcomes remain uncertain
Insights
The completion of the pre-IND meeting with the FDA marks a significant milestone for Silo Pharma's SPC-15 development. The FDA's feedback on the 505(b)(2) regulatory pathway is particularly noteworthy, as it could potentially accelerate the approval process and reduce development costs. This approach leverages existing data, which is important for a small biotech company.
The ongoing GLP-compliant pharmacokinetic and pharmacodynamic study is a critical step towards the IND submission. Positive pre-clinical data suggesting SPC-15's efficacy in combating stress-induced pathophysiology at both behavioral and neural levels is promising. However, it's important to note that success in pre-clinical stages doesn't guarantee clinical efficacy or regulatory approval.
The exclusive worldwide license from Columbia University strengthens Silo's intellectual property position, potentially increasing the company's value if SPC-15 proves successful in human trials.
This news represents a positive development for Silo Pharma, potentially de-risking their lead candidate SPC-15. The FDA's guidance on the 505(b)(2) pathway could significantly reduce time and costs associated with bringing SPC-15 to market, a important factor for a small-cap biotech company.
Investors should note that while this progress is encouraging, Silo is still in the pre-clinical stage. The company will likely need substantial funding to progress through clinical trials. The
The PTSD treatment market represents a significant opportunity, with projections reaching
Proposal submitted for FDA 505(b)(2) regulatory pathway for SPC-15 approval
Advancing path to IND submission for first-in-human trials
SARASOTA, FL, Sept. 10, 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 the completion of a pre-Investigational New Drug (pre-IND) meeting with the U.S. Food and Drug Administration (FDA) regarding the Company's development plan for SPC-15, an intranasal prophylactic treatment for post-traumatic stress disorder (PTSD) and stress-induced anxiety disorder. The pre-IND meeting was completed through written responses provided by the FDA’s Division of Regulatory Operations for Neuroscience (DRON) - Psychiatry Group.
The primary purpose of the pre-IND meeting was to align with the FDA on the 505(b)(2) regulatory pathway for approval of SPC-15 along with Silo’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.
“The FDA provided helpful written responses on our development plan for SPC-15," said Silo CEO Eric Weisblum. “We now have a clear path for advancing our development of SPC-15 into the clinic for in-human trials which will hopefully lead to FDA approval and ultimately allow us to commercialize our patented, cutting-edge intranasal treatment, to the PTSD treatment market.”
Silo is currently conducting a GLP-compliant pharmacokinetic and pharmacodynamic study in advance of an IND submission for a potential first-in-human (FIH) clinical trial of SPC-15. Pre-clinical data to date indicate that SPC-15’s optimized patient safety and therapeutic delivery has additive benefits for combating stress-induced pathophysiology, both at the behavioral and neural levels. Columbia University has granted Silo an exclusive license to further develop, manufacture, and commercialize SPC-15 worldwide.
About SPC-15
SPC-15 is a novel serotonin 4 (5-HT4) receptor agonist that utilizes biomarkers for the treatment of PTSD, anxiety, and other stress-induced affective disorders. SPC-15 is being developed as an intranasal medication. If clinically successful, SPC-15 could qualify for the FDA’s streamlined 505(b)(2) regulatory pathway for drug approval. Silo Pharma is conducting preclinical studies of SPC-15 in collaboration with Columbia University and was granted an exclusive license to further develop, manufacture, and commercialize SPC-15 worldwide.
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.
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FAQ
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