Phase I/II trials for DFU potential drug successful: NovaLead

Pune-based NovaLead Pharma today announced completion of global phase I/II clinical trial of its repositioned investigational drug, Galnobax, targeting treatment of diabetic foot ulcers (DFU).
"The recently concluded global phase I and II clinical trial of our repositioned investigational drug, Galnobax successfully met both primary and secondary end points for efficacy and safety. Galnobax will be further developed in phase-II B preferably along with a partner," the company said in a statement.
In the trial, the drug 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.

In addition, the trial reported no side effects. The data supports anticipated mechanism of action of Galnobax that it triggers the intrinsic wound healing processes impaired in diabetics.
An estimated 382 million people suffer from diabetes globally while 66.8 million suffer from the disease in India today, it said.
Diabetic foot ulcers are a frequent complication of uncontrolled diabetes and affect over 50 million people globally as 15 per cent of the diabetics suffer from DFU at least once in their lifetime.

"DFU is a global unmet medical need, with 85 per cent of non-traumatic lower limb amputations happening due to hard to heal DFU. In spite of several therapeutic options being available, a lower limb is amputated every 20 seconds.

"The phase I/II data indicates significant potential of this repositioned product to make a significant change in this situation," NovaLead Pharma Managing Director Supreet Deshpande said.
Galnobax has already received patents in all regulated markets namely the US, EU and Japan as well as in emerging markets like India and China.
Visalakshi Chandramouli, Partner, Tata Capital Healthcare Fund and on the board of directors at NovaLead said, "NovaLead's innovative, computational technology-based discovery approach has made drug repurposing a significant potential source for new treatments starting with Galnobax."
"Private equity investments have significantly opened up in the Indian healthcare and life sciences sector and we see huge growth potential in this market," she added.

NovaLead is a drug discovery research company focused on discovering new indications for generic drugs.