Silo Pharma to Initiate Dose-Ranging Study of Novel Intranasal Therapeutic for the Treatment of PTSD
Silo Pharma, Inc. recently announced plans to initiate a dose-ranging study of its targeted prophylactic treatment SPC-15 for the treatment of post-traumatic stress disorder (PTSD). The study will identify the maximum tolerated intranasal dose of the drug and pharmacokinetic in small animals to determine the therapeutically relevant dose range.
In collaboration with AmplifyBio, Silo Pharma’s contract research organization (CRO) partner, the 6- to 8-week non-good laboratory practice (GLP) study will include single ascending dose evaluation (Phase 1) and a 7-day repeat intranasal dose toxicity and pharmacokinetic study. The final validation report is expected in 2024.
“Determining the dose range that should be studied is an important step before taking a new drug candidate into a first-in-human trial,” said Eric Weisblum, Chief Executive Officer of Silo Pharma. “Completion of this study, along with our recently announced human factor study, is expected to give us an early start on our goal of a Phase 1 clinical trial of SPC-15.”
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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