Sulfateq is happy to announce that a new scientific manuscript detailing the safety of SUL-138 is published in the leading journal Toxicology Reports. This manuscript details the safety, tolerability and toxicokinetic data of SUL-138, an obligatory step in drug development. Publication coincides with a recently started Phase I trial in humans, in which the compound is administered to healthy volunteers.
SUL-138 has a broad therapeutic window
In this Good Laboratory Practice (GLP) study rats and minipigs were treated orally with vehicle or 3 dose levels of SUL-138 for 30 days. During these studies extensive in vivo, toxicokinetic, clinical pathology, necropsy and histopathology observations were performed to investigate the safety profile of SUL-138. The main aim was to determine the highest dose level that showed no adverse effects, generally referred to as the No Observed Adverse Effect Level (NOAEL). It was shown that SUL-138 was well tolerated by the rat and minipig after repeated oral administrations and there were no safety concerns raised.
About SUL-138 and the Phase I study
SUL-138 is an orally available small molecule compound which is part of the mitochondrial platform technology developed by Sulfateq. The compound is designed to improve mitochondrial function during disease. Mitochondria play a key role in the pathophysiology of Noncommunicable Chronic Diseases (NCD).
Based on the currently published preclinical results, the safety, tolerability and pharmacokinetics of SUL-138 is now being investigated in healthy human volunteers. This clinical phase I study is a major step forward in the development of this first-in-class drug towards patient benefit.
More information
The new publication is available through this link, would you like to receive more information about our compounds or discuss research or investment possibilities? Please contact us, we are happy to answer your inquiry!