Silo Pharma’s PTSD Candidate SPC-15 Achieves Positive Safety Milestone, Paving Way for Accelerated Clinical Trials Under 505(b)(2) Pathway
Silo Pharma (Nasdaq: SILO) announced positive safety results for its PTSD drug candidate SPC-15 in a FDA-requested 7-day large animal safety study. The intranasal spray formulation demonstrated local and systemic safety with no toxicities at clinical-representative doses, showing comparable systemic exposure to standard oral administration.
The company is pursuing FDA approval through the 505(b)(2) pathway, which could streamline the approval process by leveraging existing safety data. Silo is currently conducting IND-enabling GLP toxicology studies and evaluating clinical trial sites. The PTSD market, valued at $1.8 billion in 2024, is projected to reach $3.2 billion by 2034.
Silo Pharma (Nasdaq: SILO) ha comunicato risultati positivi di sicurezza per il suo candidato farmaco per il disturbo da stress post-traumatico, SPC-15, in uno studio di sicurezza su grandi animali richiesto dalla FDA della durata di 7 giorni. La formulazione spray intranasale ha mostrato sicurezza locale e sistemica senza tossicità a dosi rappresentative per l'uso clinico, con un'esposizione sistemica paragonabile a quella della somministrazione orale standard.
L'azienda mira all'approvazione FDA tramite la via 505(b)(2), che può accelerare il processo sfruttando dati di sicurezza già esistenti. Silo sta conducendo studi tossicologici GLP per l'abilitazione dell'IND e valutando i siti per gli studi clinici. Il mercato per il PTSD, valutato $1,8 miliardi nel 2024, è previsto raggiungere $3,2 miliardi entro il 2034.
Silo Pharma (Nasdaq: SILO) anunció resultados positivos de seguridad para su candidato contra el trastorno de estrés postraumático, SPC-15, en un estudio de seguridad en grandes animales solicitado por la FDA de 7 días. La formulación en spray intranasal demostró seguridad local y sistémica sin toxicidades a dosis representativas para uso clínico, mostrando una exposición sistémica comparable a la administración oral estándar.
La compañía busca la aprobación de la FDA por la vía 505(b)(2), que podría agilizar el proceso aprovechando datos de seguridad existentes. Silo está llevando a cabo estudios toxicológicos GLP para habilitar el IND y evaluando los centros para los ensayos clínicos. El mercado del PTSD, valorado en $1.800 millones en 2024, se proyecta que alcance $3.200 millones para 2034.
Silo Pharma (Nasdaq: SILO)는 FDA 요청에 따른 7일간 대형 동물 안전성 시험에서 외상 후 스트레스 장애(PTSD) 후보 약물 SPC-15의 안전성 긍정 결과를 발표했습니다. 비강 분무(인트라네이절) 제형은 임상 대표 용량에서 국소 및 전신 안전성을 보였고 독성은 관찰되지 않았으며, 전신 노출은 표준 경구 투여와 유사했습니다.
회사는 기존 안전성 데이터를 활용할 수 있는 505(b)(2) 경로를 통해 FDA 승인을 추진 중입니다. Silo는 현재 IND 승인에 필요한 GLP 독성학 연구를 진행하고 임상시험 장소를 평가하고 있습니다. PTSD 시장은 2024년 18억 달러 규모였으며, 2034년까지 32억 달러에 이를 것으로 예상됩니다.
Silo Pharma (Nasdaq: SILO) a annoncé des résultats positifs de sécurité pour son candidat médicament contre le trouble de stress post-traumatique, SPC-15, lors d'une étude de sécurité sur grands animaux de 7 jours demandée par la FDA. La formulation en spray intranasal a démontré une sécurité locale et systémique sans toxicité à des doses représentatives cliniquement, avec une exposition systémique comparable à l'administration orale standard.
La société vise une approbation FDA via la voie 505(b)(2), qui pourrait accélérer le processus en se fondant sur des données de sécurité existantes. Silo réalise actuellement des études toxicologiques GLP pour l'obtention de l'IND et évalue les sites d'essais cliniques. Le marché du PTSD, estimé à 1,8 milliard $ en 2024, devrait atteindre 3,2 milliards $ d'ici 2034.
Silo Pharma (Nasdaq: SILO) gab positive Sicherheitsbefunde für seinen PTSD-Wirkstoffkandidaten SPC-15 in einer von der FDA angeforderten 7-tägigen Sicherheitsstudie an großen Tieren bekannt. Die intranasale Sprayformulierung zeigte lokale und systemische Sicherheit ohne Toxizitäten bei klinisch repräsentativen Dosen und eine systemische Exposition, die mit der standardmäßigen oralen Gabe vergleichbar ist.
Das Unternehmen strebt die FDA-Zulassung über den 505(b)(2)-Weg an, der das Zulassungsverfahren durch Nutzung vorhandener Sicherheitsdaten beschleunigen könnte. Silo führt derzeit GLP-Toxikologiestudien zur IND-Freigabe durch und prüft Studienzentren für klinische Prüfungen. Der PTSD-Markt, mit 1,8 Mrd. $ im Jahr 2024, wird voraussichtlich 3,2 Mrd. $ bis 2034 erreichen.
- None.
- Still in early developmental stage requiring additional studies
- Multiple steps remaining before human trials can begin
- Faces competition in established PTSD treatment market
Insights
Silo Pharma's SPC-15 for PTSD passed a critical safety study, advancing toward human trials via an accelerated FDA pathway.
Silo Pharma has achieved a significant developmental milestone with its PTSD candidate SPC-15, reporting positive safety results from an FDA-requested large animal study. This is a critical step that validates their intranasal delivery approach and enables progression toward human clinical trials. The data specifically demonstrates that the intranasal formulation shows comparable systemic exposure to oral administration with no toxicities identified at clinical-representative doses.
The company's strategic approach leveraging the 505(b)(2) regulatory pathway is particularly noteworthy. This pathway allows Silo to reference previously established safety data, potentially reducing development costs and accelerating time to market. For a smaller biopharmaceutical company, this regulatory strategy is crucial for capital efficiency.
Silo is now conducting additional IND-enabling studies, including a GLP-compliant toxicology study and device testing for their microchip-based nasal spray system. These are standard but necessary steps before submitting an Investigational New Drug application to begin human trials.
The targeted nose-to-brain delivery mechanism could potentially offer advantages over traditional oral PTSD medications, particularly in onset time and possibly in side effect profile. The PTSD market presents a substantial commercial opportunity, with projections showing growth from
SPC-15’s intranasal spray formulation meets safety standards for clinical trial development
SARASOTA, FL, Aug. 19, 2025 (GLOBE NEWSWIRE) -- Silo Pharma, Inc. (Nasdaq: SILO) (“Silo” or “the Company), a diversified developmental-stage biopharmaceutical and cryptocurrency treasury company, today announced positive bioanalytical and safety/toxicology results for its U.S. Food and Drug Administration (FDA)-requested 7-day large animal safety study of its lead asset SPC-15.
Silo CEO Eric Weisblum commented, “Overall, we believe the positive results of this study confirm that SPC-15’s formulation and spray profile meets the safety standards for clinical trials. While the safety of the oral counterpart to SPC-15 is well documented, our challenge was to develop a viable intranasal therapeutic dose that meets the same safety standards while offering distinct advantages over oral delivery. So far, we believe our intranasal nose-to-brain formulation has met that challenge and supports our potential to bring a safe, easily administered, and rapidly absorbed PTSD therapeutic to market.”
The preclinical study compared the safety and overall exposure of the SPC-15 intranasal spray formulation (intended for clinical use) to oral drug administration. Data showed that SPC-15, administered at clinical-representative doses, demonstrated local and systemic safety with no toxicities identified. The study also showed that systemic exposure of intranasal SPC-15 administered at the anticipated therapeutic range is comparable to standard oral administration, which we believe validates the drug’s potential as a targeted intranasal therapeutic for PTSD and stress-induced anxiety that has a potentially greater safety profile.
In our opinion, the study data further supports Silo’s planned 505(b)(2) regulatory strategy for its SPC-15 program. This regulatory route allows companies to utilize previously established safety and efficacy data (from approved drugs) to potentially streamline the FDA drug approval process and reduce drug development costs.
Silo is currently conducting an IND-enabling GLP (Good Laboratory Practice)-compliant toxicology and toxicokinetic animal study of SPC-15, and a device study of the formulation-specific microchip-based nasal spray system. The Company is also evaluating potential clinical CRO sites for first-in-human trials.
The post-traumatic stress disorder market size reached a value of
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
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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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1 IMARC, “Post-Traumatic Stress Disorder Market Size, Epidemiology…”
2 BioSpace, “Post-Traumatic Stress Disorder Market Outlook 2024-2034”
FAQ
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