Centaur Pharma to launch WOXHeal, diabetic foot ulcer drug

Centaur Pharmaceuticals is launching a diabetic foot ulcer treatment drug Woxheal, a New Chemical Entity (NCE) in the country. The product will be made available from October 1, 2020, across the country. The drug will cost Rs 1850 for a week’s treatment.

The company will be manufacturing the medication from its facilities located in Mumbai and Goa and the active pharmaceutical ingredients (APIs) from its site located in Pune. All the three facilities are US FDA approved.

S D Sawant, Chairman and MD, Centaur Pharmaceuticals said, “It is a unique product for the treatment of diabetic foot ulcers, and we are sure that it will save millions of diabetics who have to undergo foot amputation globally. This is a result of intense research work which have been carried in the last 14 years for developing this novel drug.”

He stated, “We, at Centaur Pharmaceuticals, are deeply concerned with the alarming rate of foot amputations in India, and wanted to discover a drug to prevent it. Nearly 15 years ago, we collaborated with CytoTools AG, Germany, who had this promising molecule for the treatment of diabetic foot ulcer. We are very happy to offer this ray of hope to people with a diabetic foot ulcer in India.”

According to Dr Dirk Kaiser, the co-innovator of WOXheal and the Chief Scientific Officer of CytoTools AG, “WOXheal is a topical solution that will change the way diabetic foot ulcer management is done and will help prevent amputation. It is a novel drug born out of Indo-German collaboration and is shown to be very effective in treating diabetic foot ulcer.”

Kaiser also added that phase III clinical trials for the drug were ongoing in Europe and the results from phase II clinical trials were similar to Indian clinical trials.

Dr Mark-Andre Freyberg, the co-innovator of WOXheal and the Chief Executive Officer of CytoTools AG, Germany said, “Woxheal has completed Phase III clinical trials in India and demonstrated rapid and effective wound healing in patients with diabetic foot ulcers, a condition that is notoriously difficult to treat.”

As per information provided by the company, it is a globally patented product and contains the NCE, Diperoxochloric acid (DPOCL). It has a dual mechanism of action, i.e. functional antibacterial action against gram-positive and gram-negative bacteria. It also promotes the growth of fibroblast cells, thereby yielding complete wound closure.

To evaluate the efficacy and safety of wound healing solution DPOCL in patients with a diabetic foot ulcer, a multicentric, randomised, double-blind, double-arm, active-controlled, comparative, parallel-group clinical trial was conducted. A total of 289 patients were enrolled of which 139 patients were from the test WOXheal arm and 150 from Active-control 0.9 per cent normal saline arm. The results indicated that 105 out of 139 patients [75.54 per cent] patients from test WOXheal arm had completed wound closure, whereas 93 out of 150 patients [62 per cent] from Active-control 0.9 per cent normal saline arm had completed wound closure.

The research synopsis indicated that the test WOXheal arm showed rapid wound closure, i.e. within 42 days than Active-control 0.9 per cent normal saline arm, which was within 56 days.

The company also informed that in the randomised clinical trials, which was conducted across India in over 15 clinical trial centres, over 90 per cent patients with non-healing diabetic foot ulcer showed a reduction in the size of the ulcer, and 75 per cent out of these patients achieved complete healing within six to eight weeks without any safety issue.

The company has received the manufacturing and marketing approval from the DCGI for the product in 2019 and it has plans to export the drug to the rest of the world.