Silo Pharma Advances PTSD Drug SPC-15 Toward Planned 2025 IND Submission with Pre-Clinical Study Data Expected in Q3 2025
Silo Pharma (Nasdaq: SILO) announced significant progress in the development of SPC-15, its novel intranasal PTSD drug candidate. The company expects to receive crucial preclinical study data within 30-90 days, including results from GLP-compliant toxicology studies and an FDA-requested safety study.
The company plans to submit an IND application by end of 2025, potentially leading to Phase 1 clinical trials in 2026. Silo intends to pursue the FDA's 505(b)(2) regulatory pathway to expedite development. Notably, SPC-15's unique approach targets stress resilience, differentiating it from existing PTSD treatments, in a market where no new drugs have been approved in nearly 25 years.
Silo Pharma (Nasdaq: SILO) ha annunciato importanti progressi nello sviluppo di SPC-15, il suo innovativo candidato farmaco intranasale per il disturbo da stress post-traumatico (PTSD). L'azienda prevede di ricevere dati fondamentali da studi preclinici entro 30-90 giorni, inclusi i risultati di studi tossicologici conformi alle norme GLP e di uno studio di sicurezza richiesto dalla FDA.
La societ脿 intende presentare una domanda IND entro la fine del 2025, con la possibilit脿 di avviare studi clinici di Fase 1 nel 2026. Silo mira a seguire la via regolatoria 505(b)(2) della FDA per accelerare lo sviluppo. Da sottolineare che l'approccio unico di SPC-15, che punta alla resilienza allo stress, lo distingue dai trattamenti attuali per il PTSD, in un mercato dove non sono stati approvati nuovi farmaci da quasi 25 anni.
Silo Pharma (Nasdaq: SILO) anunci贸 avances significativos en el desarrollo de SPC-15, su novedoso candidato a medicamento intranasal para el trastorno de estr茅s postraum谩tico (TEPT). La compa帽铆a espera recibir datos clave de estudios precl铆nicos en un plazo de 30-90 d铆as, incluyendo resultados de estudios toxicol贸gicos conforme a GLP y un estudio de seguridad solicitado por la FDA.
La empresa planea presentar una solicitud IND antes de finales de 2025, lo que podr铆a conducir a ensayos cl铆nicos de Fase 1 en 2026. Silo tiene la intenci贸n de seguir la v铆a regulatoria 505(b)(2) de la FDA para acelerar el desarrollo. Cabe destacar que el enfoque 煤nico de SPC-15, que se centra en la resiliencia al estr茅s, lo diferencia de los tratamientos existentes para el TEPT, en un mercado donde no se han aprobado nuevos medicamentos en casi 25 a帽os.
Silo Pharma (雮橃姢雼�: SILO)臧� 順侅嫚鞝侅澑 牍勱皶 韴棳 PTSD 鞎诫 頉勲炒鞚� SPC-15 臧滊皽鞐愳劀 欷戩殧頃� 歆勳爠鞚� 氚滍憸頄堨姷雼堧嫟. 须岇偓电� GLP 欷�靾� 霃呾劚頃� 鞐瓣惮 氚� FDA 鞖旍箔 鞎堨爠靹� 鞐瓣惮 瓴瓣臣毳� 韽暔頃� 欷戩殧頃� 鞝勳瀯靸� 鞐瓣惮 雿办澊韯半ゼ 30-90鞚� 雮挫棎 氚涭潉 瓴冹溂搿� 鞓堨儊頃╇媹雼�.
须岇偓电� 2025雲� 毵愱箤歆� IND 鞁犾箔鞚� 瓿勴殟頃橁碃 鞛堨溂氅�, 2026雲勳棎 1靸� 鞛勳儊鞁滍棙鞚� 鞁滌瀾頃� 臧�電レ劚鞚� 鞛堨姷雼堧嫟. Silo電� 臧滊皽鞚� 臧�靻嶍檾頃橁赴 鞙勴暣 FDA鞚� 505(b)(2) 攴滌牅 鞝堨皑毳� 霐半ゼ 鞓堨爼鞛呺媹雼�. 韸鬼瀳 SPC-15電� 鞀ろ姼霠堨姢 須岆车霠レ潉 氇╉憸搿� 頃橂姅 霃呿姽頃� 鞝戧芳氩曥溂搿�, 旮办〈 PTSD 旃橂鞝滌檧 彀硠頇旊悩氅�, 瓯办潣 25雲� 霃欖晥 靸堧鞖� 鞎诫鞚� 鞀轨澑霅橃 鞎婌潃 鞁滌灔鞐愳劀 欤茧氚涥碃 鞛堨姷雼堧嫟.
Silo Pharma (Nasdaq : SILO) a annonc茅 des progr猫s significatifs dans le d茅veloppement de SPC-15, son nouveau candidat m茅dicament intranasal pour le trouble de stress post-traumatique (TSPT). La soci茅t茅 pr茅voit de recevoir des donn茅es cruciales d'茅tudes pr茅cliniques dans un d茅lai de 30 脿 90 jours, incluant les r茅sultats d'茅tudes toxicologiques conformes aux normes GLP et une 茅tude de s茅curit茅 demand茅e par la FDA.
La soci茅t茅 envisage de soumettre une demande IND d'ici la fin 2025, ce qui pourrait conduire 脿 des essais cliniques de phase 1 en 2026. Silo a l'intention de suivre la voie r茅glementaire 505(b)(2) de la FDA pour acc茅l茅rer le d茅veloppement. Notamment, l'approche unique de SPC-15, qui cible la r茅silience au stress, le distingue des traitements actuels du TSPT, dans un march茅 o霉 aucun nouveau m茅dicament n'a 茅t茅 approuv茅 depuis pr猫s de 25 ans.
Silo Pharma (Nasdaq: SILO) hat bedeutende Fortschritte bei der Entwicklung von SPC-15, seinem neuartigen intranasalen PTSD-Arzneimittelkandidaten, bekanntgegeben. Das Unternehmen erwartet innerhalb von 30-90 Tagen wichtige Daten aus pr盲klinischen Studien, darunter Ergebnisse von GLP-konformen Toxikologiestudien und einer von der FDA geforderten Sicherheitsstudie.
Das Unternehmen plant, bis Ende 2025 einen IND-Antrag einzureichen, was m枚glicherweise zu Phase-1-Studien im Jahr 2026 f眉hren k枚nnte. Silo beabsichtigt, den FDA-Regulierungsweg 505(b)(2) zu nutzen, um die Entwicklung zu beschleunigen. Bemerkenswert ist, dass der einzigartige Ansatz von SPC-15 auf Stressresilienz abzielt und sich damit von bestehenden PTSD-Behandlungen unterscheidet 鈥� in einem Markt, in dem seit fast 25 Jahren keine neuen Medikamente zugelassen wurden.
- None.
- Multiple studies still pending completion before IND submission
- Phase 1 trials won't start until 2026 at earliest, indicating long development timeline
- IND approval not guaranteed, dependent on positive preclinical results
Insights
Silo Pharma's SPC-15 for PTSD advances toward IND filing with critical preclinical data expected soon, representing potential progress in an underserved market.
Silo Pharma's announcement regarding SPC-15 represents a significant milestone in their PTSD treatment development program. The company expects to receive crucial preclinical data within the next 30-90 days from two key studies: a GLP-compliant toxicology study and an FDA-requested 7-day safety study in large animals. These studies are essential prerequisites for their planned IND submission.
What's particularly notable is the company's strategic approach to regulatory approval. By pursuing the 505(b)(2) pathway, Silo aims to potentially reduce development time and costs significantly. This regulatory route allows companies to rely partly on previously established safety and efficacy data, which can streamline the approval process.
The PTSD treatment landscape has remained stagnant for nearly 25 years with only two FDA-approved medications, both primarily targeting depression symptoms rather than the core PTSD pathology. SPC-15's novel approach targets stress resilience through an intranasal delivery system using microchip technology, which could offer improved therapeutic delivery if successful.
The market opportunity is substantial, with PTSD affecting approximately 3.9% of the global population. If Silo's timeline holds, they could potentially begin Phase 1 trials by late 2026, though investors should recognize that many developmental-stage compounds fail during the IND-enabling or clinical trial phases.
Planned submission of IND application in 2025; Phase 1 clinical trial to follow if IND application approved
No new PTSD drug approvals in the U.S. in nearly 25 years; large potential addressable market for SPC-15 worldwide
SARASOTA, FL, July 07, 2025 (GLOBE NEWSWIRE) -- Silo Pharma, Inc. (Nasdaq: SILO) (鈥淪ilo鈥� or the 鈥淐ompany鈥�), a developmental stage biopharmaceutical company focused on novel therapeutics and drug delivery systems, today announced that it expects to receive data from the additional preclinical studies of its lead asset SPC-15 within the next 30 to 90 days. SPC-15 is a novel intranasal prophylactic targeting Post-Traumatic Stress Disorder (PTSD).
The final drug studies are 1) an investigational new drug (IND)-enabling GLP (Good Laboratory Practice)-compliant toxicology and toxicokinetic animal study, and 2) a U.S. Food and Drug Administration (FDA)-requested 7-day safety and toxicology large animal study. Concurrently, a device study of the formulation-specific microchip-based nasal spray system used in SPC-15 is being conducted.
Early data on SPC-15 indicated that its optimized patient safety profile and therapeutic delivery may provide additive benefits for combating stress-induced pathophysiology at both the behavioral and neural levels.聽
Eric Weisblum, CEO of Silo, stated, 鈥淎s we await pre-clinical data within the next 90 days, we currently anticipate initiating the IND application for SPC-15 before the end of the year, assuming positive data results. If submitted and approved, this will be a pivotal achievement along our path to first-in-human trials. If the FDA approves our IND within the 30-day review period, we could initiate a Phase 1 clinical trial before the end of 2026.
鈥淢oving forward, we intend to seek the FDA鈥檚 505(b)(2) regulatory pathway for approval of SPC-15, a drug development route that can significantly shorten clinical timelines for FDA approval and reduce drug development costs,鈥� Weisblum added.
Only two drugs are currently approved by the FDA for treating PTSD, both of which primarily target the depressive effects of the condition. In contrast, SPC-15鈥檚 differentiated method of action is designed to increase stress resilience in high-risk populations. There have been no new drug approvals in nearly 25 years for the condition that affects an estimated
About SPC-15
SPC-15 is an intranasal 5-HT4 receptor agonist aimed at treating stress-induced psychiatric disorders such as PTSD and anxiety. With its potential eligibility for the FDA鈥檚 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鈥檚 portfolio includes innovative programs such as SPC-15 for PTSD, SP-26 for fibromyalgia and chronic pain, and preclinical assets targeting Alzheimer鈥檚 disease and multiple sclerosis. Silo鈥檚 research is conducted in collaboration with leading universities and laboratories.聽
Forward-Looking Statements
This news release contains "forward-looking statements" within the meaning of the 鈥渟afe harbor鈥� provisions of the Private Securities Litigation Reform Act of 1995. These statements are identified using words 鈥渃ould鈥�, 鈥渂elieve鈥�, 鈥渁nticipate鈥�, 鈥渋ntend鈥�, 鈥渆stimate鈥�, 鈥渆xpect鈥�, 鈥渕ay鈥�, 鈥渃ontinue鈥�, 鈥減redict鈥�, 鈥減otential鈥�, 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. (鈥淪ilo鈥� or 鈥渢he Company鈥�) 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鈥檚 technology platforms, retaining and expanding the Company鈥檚 customer base, fluctuations in consumer spending on the Company鈥檚 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
800-705-0120
1 FT Specialist, Endpoints in Focus, Lykos鈥� pain is others鈥� gain鈥�., June 2024.
FAQ
When will Silo Pharma (SILO) receive preclinical data for its PTSD drug SPC-15?
What makes Silo Pharma's SPC-15 different from existing PTSD treatments?
When does Silo Pharma (SILO) plan to submit the IND application for SPC-15?
What is the potential market size for Silo Pharma's PTSD drug SPC-15?
What regulatory pathway is Silo Pharma pursuing for SPC-15?
