Silo Pharma (SILO) Announces Positive Results from IND-Enabling Study of SP-26 for Fibromyalgia
Silo Pharma, Inc. (Nasdaq: SILO) (“the Company”), 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.
“Today’s positive results are an important step as we move closer to achieving all needed components to plan human trials of SP-26.” said Eric Weisblum, Chief Executive Officer of Silo Pharma. “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.”
