Silo Pharma Inc. (Nasdaq: SILO) has announced positive preclinical study results for SPC-15, a novel treatment targeting stress-related disorders. The study, evaluating SPC-15, which combines a 5-HT4R agonist with an NMDAR antagonist, demonstrated enhanced efficacy in treating stress-induced behaviors compared to single-agent treatments in animal models.
The research indicates significant improvements in behavioral outcomes related to severe stress-induced conditions. Silo Pharma is developing SPC-15 as an intranasal prophylactic treatment for Post-Traumatic Stress Disorder (PTSD) and plans to submit an Investigational New Drug (IND) application for first-in-human trials.
Dual-Action Approach Shows Superior Efficacy
The preclinical study highlighted the potential of SPC-15's dual-targeting mechanism. By simultaneously targeting the serotonin 5-HT4 receptor (5-HT4R) and the NMDA receptor (NMDAR), the combined treatment demonstrated a significant improvement in behavioral outcomes related to severe stress-induced conditions compared to using either agent alone.
Eric Weisblum, CEO of Silo Pharma, stated, "We are encouraged by these results, which point to what we believe is a promising new approach for managing severe stress-related psychiatric disorders. In our opinion, our dual-action strategy with SPC-15 demonstrates the potential to provide an effective treatment option for patients experiencing severe and relapsed stress-related disorders."
Development Plans for SPC-15
Silo Pharma is advancing the development of SPC-15 as an intranasal prophylactic treatment for PTSD. The company aims to submit an IND application to initiate first-in-human trials. SPC-15, a novel serotonin 4 (5-HT4) receptor agonist, utilizes biomarkers for treating PTSD, anxiety, and other stress-induced affective disorders. The intranasal delivery route, if clinically successful, could allow SPC-15 to 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 and holds an exclusive license to further develop, manufacture, and commercialize SPC-15 worldwide.
