Silo Pharma is embarking on a preclinical toxicity study of its novel time-released, dosage-controlled formulation of ketamine – SP-26 – for the treatment of fibromyalgia.
In the study, the tolerability of the SP-26 compound will be determined in a mini-pig study using an ascending (descending) dosing regimen. Data from the study is expected in the first quarter of 2023.
The development follows Silo Pharma’s recent announcement that it is preparing a pre-Investigational New Drug (IND) package and meeting request with the United States Food and Drug Administration (FDA) for SPC-26 for the treatment of fibromyalgia.
CEO of Silo Pharma, Eric Weisblum, commented: “We are working closely with our joint venture partner Zylö Therapeutics in developing a topical sustained released ketamine utilizing Z-pod™ technology.
“Preclinical studies have already shown that our joint developed delivery method and formulation can hold and distribute ketamine in a time-released manner. SP-26 reported positive results in reducing neuropathic nerve pain.
“This safety evaluation study will uncover maximum tolerated dosing data that will inform our future trials.”
So far, pre-clinical studies have shown that the Z-pod can hold and distribute ketamine in a time-released manner, and the company has determined to pursue fibromyalgia as an initial indication.
The company intends to pursue a 505(b)(2) regulatory pathway for the drug candidate. Premier Consulting will assist Silo Pharma with the development of its nonclinical, clinical, clinical pharmacology and biopharmaceutics strategy and programme to be proposed to the FDA.
