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Pune-based NovaLead Pharma, a drug discovery and development company, announced a potential breakthrough in the treatment of diabetic foot ulcers (DFU), which is a frequent complication of uncontrolled diabetes over a period of time.
The recently concluded global Phase I/II clinical trial of its repositioned investigational drug, Galnobax successfully met both primary and secondary end points for efficacy and safety.
The scientific challenge in this discovery can be understood by the fact that the last and the only USFDA approved drug for DFU came in 1997.
The gel can be self-administered at home without significant side-effects thus providing additional benefits to patients in terms of convenience and saving hospital costs
In this trial, Galnobax demonstrated significant benefit over placebo in terms of ability to close hard to heal DFUs in much shorter time, making it potentially the first small molecule drug for DFU.