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NovaLead Pharma to launch drug for diabetic foot ulcer

Shardul Nautiyal, Mumbai
Wednesday, November 4, 2015, 08:00 Hrs  [IST]

Based on the successful completion of global phase I/II clinical trial for Galnobax- a topical gel for treatment of diabetic foot ulcer (DFU), Pune based NovaLead Pharma plans to launch the drug in 2018. Global research in this disease area has not delivered a more effective drug. The last and only drug approved by US FDA was in 1997 and that too has a black box warning for safety.  

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 company has recently announced promising results from the successful completion of global phase I/II clinical trials of Galnobax.

Galnobax is a formulation of a repositioned cardiac drug in a gel form for topical use. Drug repositioning is a process of retargeting old or existing drugs for potentially new therapeutic applications. By using a more systematic approach, existing compounds are being tested for both hard to heal diseases and unmet medical needs.

With the discovery of Galnobax, NovaLead has established an existing generic drug base as a potential source for novel therapeutics for hard to treat diseases. The drug has already received patents in all regulated markets namely USA, EU and Japan as well as in emerging markets like India and China. Further development of Galnobax is de-risked almost to half as there are no safety concerns; the molecule being an already approved generic drug. It has found to meet both primary and secondary endpoints of efficacy and safety and shows significant potential to become the first line treatment for diabetic foot ulcers. It has recently been adjudged as the Best Innovation in Healthcare in 2015 by DBT - BIRAC which is an initiative of the department of biotechnology, government of India.

Galnobax has the potential to be the first small molecule drug for diabetic foot ulcer and has significant benefit over placebo in wound closure ability within much lesser time especially for hard to heal DFUs. It can be self-administered at home without significant side-effects thus providing additional benefits to patients in terms of convenience and saving hospital costs. Galnobax will be further developed by NovaLead in phase-II B preferably along with a partner.

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. 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.

Supreet Deshpande, managing director, NovaLead and president of its US subsidiary- NovaLead Pharma Inc said, “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 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.”

Dr P K S Sarma, head technical - Discovery and 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 and 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.”

Based in Pune with a wholly owned subsidiary in USA, the entire drug discovery activity of NovaLead is powered by proprietary computational technology. It has a thriving pipeline of repurposed generic drug candidates. Tata Capital Healthcare Fund and Boxmoor are the present investors in NovaLead while, the first investors Kotak Mahindra Private Equity has already received a successful exit. Innovative computational technology based discovery approach of NovaLead Pharma has made drug repurposing a significant potential source for new treatments for unmet and hard to treat diseases.


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