Scottish biotechnology company Kynos Therapeutics has announced successful completion of the first tests in humans of its leading drug candidate to reduce tissue damage caused by inflammation.
The company, a spin-out from the University of Edinburgh, said its drug known as KNS366 was shown to be a "potent inhibitor" of the enzyme responsible for inflammation in medical conditions such as acute kidney injury and pancreatitis during a Phase I clinical trial during which healthy adults were given multiple doses over a seven-day period.
Phase I is the first step in testing a new treatment in humans, assessing the safety, side effects, and best dosage of a potential drug. This is followed by Phase II studies to determine the effectiveness of an experimental drug on a specific disease, and Phase III trials to determine whether the new drug is more effective than current treatments.
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Kynos co-founder and chief scientific officer Damian Mole said information from the study will help determine doses for future clinical studies in patients.
"To our knowledge, this is the first time a KMO inhibitor has been administered across multiple days resulting in sustained KMO inhibition in humans," he said. "We are therefore also able to generate information on the biological pathways impacted by this mechanism in humans, through an ongoing exploratory biomarker analysis as a valuable tool to inform further clinical development.”
The company’s pipeline of KMO inhibitors was originally co-developed through a collaboration between pharmaceutical giant GSK and the University of Edinburgh and is now exclusively licensed to Kynos. The business has financial backing from founding investor Epidarex Capital as well as IP Group and Scottish Enterprise, with additional non-dilutive funding from Innovate UK.
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“The successful completion of this Phase I study is a significant milestone for Kynos and the results provide an excellent basis for further development of KNS366," chief executive Jonathan Savage said.
"The full analysis of the wealth of data from the study will generate invaluable information on this first-in-class mechanism to enable optimization of the further clinical development pathway. We appreciate the funding contribution from Innovate UK to conduct this important clinical trial.”
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