Silo Pharma Successfully Completes First Phase of Dose-Ranging Study of SPC-15 an Intranasal Treatment for PTSD
Silo Pharma, Inc. recently provided an update on its previously announced dose-ranging study of SPC-15, a targeted prophylactic treatment for post-traumatic stress disorder (PTSD). The purpose of the study is to identify the maximum tolerated intranasal dose of the drug and pharmacokinetic in small animals to determine the therapeutically relevant dose range with the goal of bringing us closer to human trials.
The 6- to 8-week non-GLP study includes single ascending dose evaluation (Phase 1) and a 7-day repeat intranasal dose toxicity and pharmacokinetic study. In the first phase of the study, all of the animals appeared to tolerate the intranasal dosing procedure well, with minimal struggling and no sneezing observed. The final validation report is expected in the first quarter of 2024.
Eric Weisblum, Chief Executive Officer of Silo Pharma, said “There have been no adverse clinical observations reported to date for this study, which began in late November 2023 and will conclude in first quarter 2024. If successful, this non-GLP study will be followed by a GLP safety and toxicology study, both of which will be utilized in connection with filing an expected Investigational New Drug (IND) application with the FDA.”
Preclinical data has shown that SPC-15 has additive benefits for combating stress-induced pathophysiology, both at the behavioral and neural levels. Preclinical collaborative work with Columbia University will be coupled with published preclinical data in a pre-IND application to the FDA, which the company expects to submit during the first quarter of 2024.
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 under a sponsored research agreement and option.
Silo Pharma Inc. is a development-stage biopharmaceutical company focused on merging traditional therapeutics with psychedelic research for people suffering from indications such as PTSD, Alzheimer’s disease, and other rare neurological disorders. Silo’s mission is to identify assets to license and fund the research we believe will be transformative to the well-being of patients and the healthcare industry. For more information, visit www.silopharma.com.
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