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news.HaptoGuard has filed an investigational new drug application with the FDA for BXT-51072; an anti-inflammatory drug that the company believes could be effective in combating heart problems brought on by diabetes.
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The drug has previously been studied by Oxis International in an indication to treat ulcerative colitis. Because phase I safety studies were performed by Oxis during these trials, HaptoGuard now hope that they will be given the go ahead to move straight in to phase II clinical trials for cardiovascular indications.
The potential use of this drug in cardiovascular indications has generated enthusiasm because glutathione peroxidase, the naturally occurring enzyme whose function is mimicked by the drug, has been convincingly associated, epidemiologically, with myocardial protection in human clinical trials.
This oral drug metabolizes toxic, oxidized fats found in blood vessels and heart muscle of diabetic patients and may shut down the inflammatory machinery that induces a high rate of heart failure and death in diabetic patients following a heart attack.
“This IND for BXT-51072 represents a significant step forward in our determined effort to develop a novel and much needed therapy for the diabetic community,” said Noah Berkowitz chairman and CEO of HaptoGuard. “Our plan is to initiate our phase II program shortly after our IND is approved.”