NovaLead Pharma completes global phase I /II clinical trial for Galnobax

By Sanjiv Das On Nov 4, 2015

20151115ep42 — (L-R): Dr PK S Sarma, Head Technical – Discovery & Product Development, Biotechnology Industry Research Assistance Council, a Government of India Enterprise, Homi Khusrokhan- Senior Advisor ,Tata Capital, Prakash Bhoopatkar, Chartered Accountant and a Management Consultant, Trustee and Vice-Chairman of Chellaram Foundation, Supreet Deshpande, Managing Director, NovaLead Pharma and President of its US subsidiary, Dr Manisha Deshmukh, Practicing Physician and Diabetologist, Fellow of Diabetic Foot Clinic, Kings College Hospital (London) and Honorary Consultant, Diabetic Foot at Deenanath Mangeshkar Hospital (DMH, Pune) and Dr Sanjay M Vaidya Practicing Plastic, Cosmetic and Diabetic Foot surgeon

Galnobax, a topical gel, will help in the treatment of diabetic foot ulcer

NovaLead Pharma announced a potential breakthrough in the treatment of diabetic foot ulcers (DFU). 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.

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.

In comparison to the published data of existing therapies like growth factors and skin grafts, Galnobax trial data is considerably superior in terms its wound closing ability as well as the time to heal. That it is self-administrable, Galnobax is likely to save expenses for the patients and also ensure better compliance.

This innovation is noteworthy because Galnobax is a generic drug originally indicated for a cardiac condition, repositioned by NovaLead for DFU in a gel form for topical use. Galnobax is discovered through NovaLead’s proprietary technology platform which enables systematic approach for finding novel therapeutic indications for known drug molecules. Using this platform NovaLead has generated a robust pipeline of which Galnobax is the first candidate in human trial.