Biotechnology spinout Kynos Therapeutics has announced positive results from its first in-human phase I trial of its lead drug candidate, KNS366.
The company, spun out by researchers from the University of Edinburgh’s Centre for Inflammation Research and Centre for Cardiovascular Research following a decade of research, is developing a portfolio of first-in-class kynurenine 3-monooxygenase (KMO) inhibitors.
KMO plays a major role in the regulation of inflammation, acting at the interface between inflammation, immunity and metabolism. Inhibition of KMO has therapeutic potential in both acute inflammatory conditions, such as acute kidney injury and acute pancreatitis, and in chronic immuno-inflammatory disorders.
The Phase I study of KNS366 was a randomized, double-blind, placebo-controlled dose escalation study evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple doses of KNS366 in healthy adult participants. During the multiple dose part, KNS366 was administered over seven days.
All doses of KNS366 were safe and the molecule showed excellent tolerability. Pharmacodynamic measures clearly demonstrated KNS366 is a potent inhibitor of the KMO enzyme, with a high level of inhibition achieved as demonstrated by a substantial reduction in the enzyme product 3-HK.
Professor Damian Mole, 1777 Chair of Surgery at the University of Edinburgh, who co-founded Kynos with Professor Scott Webster, said:
The headline data from this Phase I study have demonstrated KNS366 is safe and well tolerated at exposures that resulted in a high level of KMO enzyme inhibition. Information from the study including pharmacodynamic measures enables the selection of 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. 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. ”
Edinburgh Innovations (EI) assisted the academic founders and team throughout the industry engagement and spinout process and continues to provide support to the company.
Dr Susan Bodie, Head of Business Development for the College of Medicine and Veterinary Medicine at EI, said:
The journey from research to impact is a long one, and seeing a drug candidate make it through its first in-human trial is a wonderful milestone, testament to the thriving innovation ecosystem we have here at Edinburgh.
These positive trial results are fantastic news for the Kynos team, for those who have supported them over the years and, of course, for those patients who ultimately stand to benefit. ”
Jonathan Savidge, Kynos Therapeutics CEO, said:
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.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. ”
