DanioLabs has announced the start of a Phase I proof-of-concept trial of DL06001 and DL06002 for sialorrhoea (drooling) and hyperhidrosis (excessive sweating) in Parkinson's disease as the company aim to meet the need for treating these associated disorders.
DL06001 and DL06002 are new combinations of established drugs with a long history of safe use. DanioLabs' strategy identifies and enhances known drug compounds for new, innovative therapeutic applications, with the aim of out-licensing products for further development and commercialisation.
According to the World Health Organisation (WHO), neurodegenerative diseases such as Parkinson's disease are set to become the second main cause of death by 2040, after cardiovascular disease.
Currently, there are approximately four million Parkinson's disease sufferers worldwide, creating a market for Parkinson's disease treatments worth approximately $2.8bn (€2.2bn)
DanioLabs have a lot riding on this, as these are the first of the company's programmes to enter the clinic. The study is being conducted in the UK on human volunteers and is expected to finish later this year. Results are expected to be announced by December 2006.
"We are delighted that the Company's first clinical trial for the alleviation of sialorrhoea and hyperhidrosis has begun, creating an opportunity to improve the quality of life in Parkinson's disease sufferer," said Tony Sedgwick, DanioLabs' CEO.
"This Phase I proof-of-concept study is an important milestone for DanioLabs and reflects the continuing development of our product pipeline and validates the Company's drug reprofiling strategy which enables the early generation of clinical data."
The Company's approach to reprofiling is based upon identifying opportunities through clinical observation, as well as systematic screening of drug libraries in high-throughput zebrafish disease models.
While Parkinson's disease is classically associated with slowness, stiffness and tremor, it is increasingly recognised that patients also suffer from other symptoms that can markedly decrease quality of life, including sialorrhoea and hyperhidrosis.
Given the increasing growth of the Parkinson's disease population and the lack of effective treatments for sialorrhoea and hyperhidrosis, this area of unmet medical need represents a significant commercial opportunity.
The company added that its Parkinson's disease products may have potential in a broader spectrum of indications, such as sialorrhoea in patients with cerebral palsy or oesophageal cancer and excessive sweating in general.