Diabetic drug enters 2nd-stage human testing
A new Traditional Chinese Medicine (TCM) herbal medication for treating diabetic-induced chronic wounds, named WH-1, has been approved by the US FDA to enter second-stage human testing. WH-1 is composed of two Chinese herbs, including one that is relatively rare and growing in Taiwan. WH-1 has been assessed to be very competitive on the world market as a chronic wound-healing agent as it is cost effective to manufacture and has a superior stability profile.
With diabetic patients commonly suffering from slow wound healing; diabetic foot ulcers are particularly difficult to manage. Relevant pharmaceuticals in the treatment of this condition command a global market worth of about US$3 billion. In the US, Regranex is the only FDA approved diabetic foot ulcer wound healing medication, and being a protein product it is expensive (more than US$600 a 15 g tube) and has to be stored at 4 degrees C.
WH-1 is currently under investigation in a Phase II clinical study in the treatment of Wagner grade 1 foot ulcers in diabetic patients. In order to further explore the wound healing efficacy of WH-1 in clinical applications, a randomized control study for grade 3 foot ulcers in diabetic patients will be performed. Worldwide patents of WH-1 have already been filed.
The market prospects and the advantage of WH-1
Foot ulcers are the most frequent cause of diabetes-related hospitalization. Diabetes is now the top cause of non-traumatic leg amputations in the developed world. Thus, diabetic foot ulcers and related infections result in long-term disabilities for patients with the condition and subsequent high demands on the healthcare system.
Today's ageing population is also a key driver of the advanced wound management market as the elderly account for a significant portion of chronic wound-related cases. Overall, the global advanced wound care management market is about US$5 to 7 billion with steady annual market growth of around 8.3%.
In comparison to Regranex, WH-1 has similar wound healing efficacy, and being an extract of botanical material, has considerable prior human use experience. It is cost effective to manufacture (less than US$2 for a 15g tube) and has a stable storage profile. In addition to accelerating tissue regeneration for wound closure, WH-1 also has antiseptic and anti-inflammatory properties. With these benefits, WH-1 can be considered a promising candidate for the treatment of diabetic-induced foot ulceration, burn healing and bed sore ulceration.
