NovaLeadPharma announces successful completion of global phase I , II clinical trial for Galnobax

"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 US FDA approved drug for DFU came in 1997," the company said in a statement.

"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. In addition the trial reported no side effects of any significance. The data supports anticipated mechanism of action of Galnobax that it triggers the intrinsic wound healing processes impaired in diabetics," it said.

Supreet Deshpande, Managing Director, NovaLead and President of its US subsidiary- NovaLead Pharma Inc said, “DFU is a global unmet medical need, with 85% 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 of Galnobax® indicates significant potential of this repositioned product to make a significant change in this situation. By repositioning a generic drug previously used for a heart condition, NovaLead has established that the existing generic drug base can be a potential source for novel therapeutics for hard to treat diseases like DFU.”

P.K. S Sarma, Head Technical - Discovery & Product Development, Biotechnology Industry Research Assistance Council, a Government of India Enterprise commented, “NovaLead’s latest innovation is very noteworthy because Diabetic Foot Ulcers is a major unmet medical need in our country and Galnobax® promises to fill in this gap. With the results of clinical trials data being very encouraging so far, it is my hope that Galnobax® can reach patients soon at an affordable price.”

Speaking on this discovery and what it means for the Life Sciences industry, 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 & Life Sciences sector and we see huge growth potential in this market. We continue to seek compelling investment opportunities in companies that have strong business fundamentals for growth and an ability to create trusted brands in the Healthcare and Life Sciences sector.”