Silo Pharma Selects Veloxity Labs for Bioanalytical IND-Enabling Study for our Novel Intranasal PTSD Therapy, SPC-15
Silo Pharma (NASDAQ: SILO) has selected Veloxity Labs to conduct bioanalytical work for its IND-enabling GLP toxicology and toxicokinetics study of SPC-15, the company's lead drug candidate. SPC-15 is being developed as an intranasal prophylactic treatment for post-traumatic stress disorder (PTSD).
The company plans to initiate the FDA IND process for SPC-15 in 2025, and upon approval, will advance to a Phase 1 clinical trial. CEO Eric Weisblum expressed confidence in Veloxity Labs' ability to deliver fast turnaround times and precise data needed for the IND submission.
Silo Pharma (NASDAQ: SILO) ha scelto Veloxity Labs per svolgere il lavoro bioanalitico relativo allo studio tossicologico e tossicocinetico GLP per l'abilitazione dell'IND di SPC-15, il principale candidato farmaco dell'azienda. SPC-15 è in fase di sviluppo come trattamento profilattico intranasale per il disturbo da stress post-traumatico (PTSD).
L'azienda prevede di avviare il processo IND presso la FDA per SPC-15 nel 2025 e, una volta ottenuta l'approvazione, passerà a una sperimentazione clinica di Fase 1. Il CEO Eric Weisblum ha espresso fiducia nella capacità di Veloxity Labs di fornire tempi di risposta rapidi e dati precisi necessari per la presentazione dell'IND.
Silo Pharma (NASDAQ: SILO) ha seleccionado a Veloxity Labs para realizar el trabajo bioanalítico del estudio toxicológico y toxico cinético GLP que habilita el IND de SPC-15, el principal candidato a medicamento de la compañía. SPC-15 se está desarrollando como un tratamiento profiláctico intranasal para el trastorno de estrés postraumático (TEPT).
La empresa planea iniciar el proceso IND ante la FDA para SPC-15 en 2025 y, una vez aprobado, avanzará a un ensayo clínico de Fase 1. El CEO Eric Weisblum expresó confianza en la capacidad de Veloxity Labs para entregar resultados rápidos y datos precisos necesarios para la presentación del IND.
Silo Pharma (NASDAQ: SILO)는 회사의 주요 약물 후보인 SPC-15의 IND 승인용 GLP 독성 및 독성동태학 연구를 위한 생물분석 작업을 수행할 업체로 Veloxity Labs를 선정했습니다. SPC-15는 외상 후 스트레스 장애 (PTSD)에 대한 비강 내 예방 치료제로 개발 중입니다.
회사는 2025년에 SPC-15의 FDA IND 절차를 시작할 계획이며, 승인 후 1상 임상시험으로 진행할 예정입니다. CEO Eric Weisblum은 IND 제출에 필요한 빠른 처리 시간과 정확한 데이터를 제공할 Veloxity Labs의 능력에 대한 신뢰를 표명했습니다.
Silo Pharma (NASDAQ : SILO) a choisi Veloxity Labs pour réaliser les analyses bioanalytiques dans le cadre de l'étude toxicologique et toxicocinétique GLP nécessaire à l'autorisation IND de SPC-15, le principal candidat médicament de la société. SPC-15 est développé comme un traitement prophylactique intranasal du trouble de stress post-traumatique (TSPT).
L'entreprise prévoit de lancer la procédure IND auprès de la FDA pour SPC-15 en 2025, et après approbation, passera à un essai clinique de phase 1. Le PDG Eric Weisblum a exprimé sa confiance dans la capacité de Veloxity Labs à fournir des délais rapides et des données précises nécessaires à la soumission de l'IND.
Silo Pharma (NASDAQ: SILO) hat Veloxity Labs mit der bioanalytischen Arbeit für die IND-freigebende GLP-Toxikologie- und Toxikokinetik-Studie von SPC-15 beauftragt, dem führenden Arzneimittelkandidaten des Unternehmens. SPC-15 wird als intranasale Prophylaxe zur Behandlung von posttraumatischer Belastungsstörung (PTSD) entwickelt.
Das Unternehmen plant, den FDA-IND-Prozess für SPC-15 im Jahr 2025 zu starten und nach Genehmigung in eine Phase-1-Studie überzugehen. CEO Eric Weisblum zeigte sich zuversichtlich, dass Veloxity Labs die schnellen Bearbeitungszeiten und präzisen Daten liefern kann, die für die IND-Einreichung erforderlich sind.
- Progress in IND-enabling studies for lead asset SPC-15
- Clear timeline for FDA IND submission in 2025
- Partnership with established lab for critical bioanalytical work
- Early-stage development with no guarantee of IND approval
- No revenue generation at current developmental stage
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 engaged Veloxity Labs, LLC for bioanalysis supporting the ongoing investigational new drug (IND)-enabling GLP (Good Laboratory Practice)-compliant toxicology and toxicokinetics study of its lead asset, SPC-15, an intranasal prophylactic treatment for post-traumatic stress disorder (PTSD).
“We look forward to working with Veloxity Labs for GLP sample analysis in our current safety study of SPC-15,” said Eric Weisblum, CEO of Silo. “We expect Veloxity to provide fast turnaround times and precise, high-quality data, and we believe their team will play an important role in delivering preclinical data we need to open an IND for SPC-15.”
Silo expects to begin the FDA IND process for SPC-15 in 2025. Upon approval of the IND, Silo will proceed to a first-in-human Phase 1 clinical trial.
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.
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