Silo Pharma Partners with Allucent to Support Planned FDA Investigational New Drug Application for SPC-15 as a Therapeutic for PTSD
Silo Pharma (Nasdaq: SILO) selected Allucent, a global clinical research organization, to support final preparations and its planned FDA IND submission in 2026 for a Phase 1 first-in-human trial of intranasal SPC-15 as a therapeutic for PTSD.
The company expects IND-enabling GLP toxicology/toxicokinetic data and a drug-device study for its formulation-specific intranasal spray system in early 2026, and intends to pursue the FDA’s 505(b)(2) accelerated pathway. Trial start is contingent on FDA IND approval; Silo described Allucent’s role as preparing dose-ranging protocols to assess SPC-15 pharmacokinetics and safety.
Silo Pharma (Nasdaq: SILO) ha selezionato Allucent, un organizzaione globale di ricerca clinica, per supportare i preparativi finali e la prevista presentazione IND FDA nel 2026 per uno studio di fase 1 nell'uomo di SPC-15 per via intranasale come terapia per il PTSD.
L'azienda si aspetta dati tossicologici/tossicocinetici GLP che abiliteranno l'IND e uno studio farmaco-dispositivo per il sistema di spray intranasale specifico per la formulazione all'inizio del 2026, e intende seguire il percorso accelerato 505(b)(2) della FDA. L'inizio dello studio dipende dall'approvazione dell'IND da parte della FDA; Silo ha descritto il ruolo di Allucent come la preparazione di protocolli di range di dosi per valutare la farmacocinetica e la sicurezza di SPC-15.
Silo Pharma (Nasdaq: SILO) eligió a Allucent, una organización global de investigación clínica, para apoyar los preparativos finales y su prevista presentación IND ante la FDA en 2026 para un ensayo de fase 1 en humanos de SPC-15 por vía intranasal como tratamiento para el PTSD.
La compañía espera datos toxicológicos/toxocinéticos GLP que habiliten el IND y un estudio de fármaco-dispositivo para su sistema de spray intranasal específico de la formulación a principios de 2026, y tiene la intención de seguir la ruta acelerada 505(b)(2) de la FDA. El inicio del ensayo depende de la aprobación del IND por parte de la FDA; Silo describió el papel de Allucent como la preparación de protocolos de rango de dosis para evaluar la farmacocinética y la seguridad de SPC-15.
Silo Pharma (나스닥: SILO)는 글로벌 임상 연구 기관 Allucent를 선정하여 최종 준비를 지원하고 2026년 FDA IND 제출 예정에 따라 PTSD 치료제로서 비강 투여 SPC-15의 1상 인체 첫 투여 시험에 대한 계획을 추진합니다.
회사는 IND를 가능하게 하는 GLP 독성학/독동역학 데이터와 제형별 비강 스프레이 시스템을 위한 약물-장치 연구를 2026년 초에 기대하고 있으며, FDA의 505(b)(2) 가속 경로를 추구할 예정입니다. 시험 시작은 FDA의 IND 승인을 조건으로 하며, Allucent의 역할은 SPC-15의 약물동학 및 안전성을 평가하기 위한 용량 범위 프로토콜을 준비하는 것으로 설명되었습니다.
Silo Pharma (Nasdaq : SILO) a choisi Allucent, une organisation mondiale de recherche clinique, pour soutenir les préparatifs finaux et sa présentation IND FDA prévue en 2026 pour un essai de phase 1 sur l'homme intranasal SPC-15 en tant que thérapeutique pour le TSPT.
L'entreprise attend des données toxico-GLP qui habilitent l'IND et une étude médicament- dispositif pour son système de spray intranasal spécifique à la formulation au début 2026, et entend poursuivre la voie accélérée 505(b)(2) de la FDA. Le démarrage de l'essai dépend de l'approbation de l'IND par la FDA; Silo a décrit le rôle d'Allucent comme la préparation de protocoles de dose-ranging pour évaluer la pharmacocinétique et la sécurité de SPC-15.
Silo Pharma (Nasdaq: SILO) hat Allucent, eine globale Organisation für klinische Forschung, ausgewählt, um die endgültigen Vorbereitungen zu unterstützen und die geplante FDA-IND-Einreichung im Jahr 2026 für eine Phase-1-Studie am Menschen mit intranasalem SPC-15 als Therapeutikum gegen PTBS zu begleiten.
Das Unternehmen erwartet IND-fähige GLP-Tox-/Toxikokinetik-Daten sowie eine Dosis-Entwicklungs-Studie für das formulierungs-spezifische intranasale Spray-System Anfang 2026 und beabsichtigt, den beschleunigten FDA-505(b)(2)-Weg zu verfolgen. Der Studienbeginn hängt von der FDA-IND-Zustimmung ab; Silo beschrieb Allucents Rolle als die Vorbereitung von Dosisbereich-Protokollen zur Bewertung der Pharmakokinetik und Sicherheit von SPC-15.
سيلو فارما (ناسداك: SILO) اختارت Allucent، وهي منظمة أبحاث سريرية عالمية، لدعم التحضيرات النهائية وتقديم IND لدى FDA المخطط في 2026 لدراسة المرحلة الأولى على البشر لـ SPC-15 عن طريق الأنف كعلاج لاضطراب ما بعد الصدمة (PTSD).
تتوقع الشركة بيانات تسمح بإتاحة IND تشمل سمية GLP وتقييم دواء-الجهاز لنظام الرش الأنفي الخاص بالتركيبة في أوائل 2026، وتعتزم اتباع مسار FDA الأسرع 505(b)(2). بدء التجربة يعتمد على موافقة IND من FDA؛ ووصفت Silo دور Allucent بأنه إعداد بروتوكولات مدى الجرعات لتقييم فارماكوكينتيك SPC-15 والسلامة.
- IND submission expected in 2026
- GLP toxicology and toxicokinetic data expected early 2026
- Partnered with global CRO Allucent for IND preparations
- Pursuing FDA 505(b)(2) accelerated pathway
- First-in-human trial contingent on FDA IND approval
- Company expects results; preclinical positive outcomes are not guaranteed
SARASOTA, FL, Nov. 17, 2025 (GLOBE NEWSWIRE) -- Silo Pharma, Inc. (Nasdaq: SILO) (“Silo” or “the Company), a diversified developmental-stage biopharmaceutical and cryptocurrency treasury company, today announced that it has selected Allucent, a global full-service clinical research organization (CRO), to support the Company’s final preparations and planned submission of its investigational new drug application (IND) to the FDA for a Phase 1 clinical trial of its intranasal prophylactic SPC-15 as a treatment for PTSD. The Company currently expects to submit the IND in 2026 and commence its first-in-human (FIH) SPC-15 trial subsequent to FDA approval.
“We believe that a partnership with Allucent, is a significant move forward in bringing our novel PTSD therapeutic to the clinic,” said Silo CEO Eric Weisblum. “With Allucent’s expertise, we believe our IND will provide a sound rationale for clinical development, beginning with protocols for dose-ranging studies to assess the pharmacokinetics and safety profile for SPC-15. We expect to receive positive preclinical results in these categories which should meet the FDA’s clinical trial standards.”
Data from an IND-enabling GLP (Good Laboratory Practice)-compliant toxicology and toxicokinetic study, along with findings from a drug-device study of the formulation-specific intranasal spray system used for SPC-15 drug delivery, are expected in early 2026. Silo intends to pursue the FDA’s 505(b)(2) accelerated regulatory pathway for clinical development of SPC-15.
About Silo Pharma
Silo Pharma is a diversified developmental-stage biopharmaceutical and cryptocurrency treasury company. Its therapeutic focus is 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
About Allucent
Allucent is on a mission to help bring new therapies to light by solving the distinct challenges faced by biopharma and government clients. A global provider of comprehensive drug development solutions, including consulting, clinical operations, biometrics, and clinical pharmacology across a range of therapeutic areas, Allucent brings more than 30 years of experience in over 60 countries. With an A-Team of former regulators, leading scientists, and clinical experts, Allucent’s individualized partnership approach delivers deep insights and hands-on expertise to help clients navigate the complexities of bringing innovative treatments to patients. Learn more at allucent.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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