Silo Pharma, Inc. (Nasdaq: SILO), a developmental stage biopharmaceutical company focused on merging traditional therapeutics with psychedelic research, today announced that it has achieved positive results for its toxicology study of SP-26, its novel time-released, dosage-controlled formulation of ketamine. The study results evaluated the feasibility of using a rising dose design or maximum feasibility.
In collaboration with Experimur, a Frontage Laboratories company, Silo Pharma tested SP-26 in a toxicology and tolerability study in mini pigs using an ascending (descending) dosing regimen. The study utilized the bioanalytical methods required to perform toxicology studies by the U.S. Food and Drug Administration (FDA) in advance of initiating clinical studies for SP-26.
Eric Weisblum, Chief Executive Officer of Silo Pharma
“Today’s positive results are an important step as we move closer to achieving all needed components to plan human trials of SP-26. We are advancing our work with our regulatory partners to prepare a Pre-Investigational New Drug (IND) package for SP-26 and intend to pursue the FDA’s streamlined 505(b)(2) regulatory pathway for drug approval.”
About Silo Pharma
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 which we believe will be transformative to the well-being of patients and the healthcare industry.