Perth-based neurology research company NeuroDiscovery Ltd will seek approval from the British Medicines and Healthcare products Regulatory Agency to extend trials of neuropathic pain treatment NSL-043 to higher doses, after the first phase of trials was c
Perth-based neurology research company NeuroDiscovery Ltd will seek approval from the British Medicines and Healthcare products Regulatory Agency to extend trials of neuropathic pain treatment NSL-043 to higher doses, after the first phase of trials was completed.
The full text of a company announcement is pasted below
NeuroDiscovery Ltd (ASX: NDL) a neurology-focused research and development company, is pleased to announce an update on the status of its current Single Ascending Dose trial undertaken in collaboration with its 50/50 partner Sosei Group Corporation (Sosei).
The trial was a double-blind, placebo-controlled, single-dose, sequential-group, dose escalation trial in forty healthy male volunteers to assess the safety, tolerability and pharmacokinetic profile of NSL-043 administered as an oral dose.
The original protocol for the Phase I trial was completed on time with five cohorts receiving single ascending doses up to 600mg of NSL-043 in oral capsule format.
Due to the trial's emerging positive safety profile, the company has decided to extend the trial to explore higher doses and is awaiting approval from the UK MHRA to proceed.
Two additional higher dosing cohorts are now planned with an anticipated administration of the first dose in mid October 2007. By exploring the upper dose ranges of NSL-043 the company will have greater dosing flexibility in the Phase IIa trial. Once completed and when the results are fully analysed, the Company will make an additional announcement.
The expansion of this Phase I trial does not affect the timelines for the planned multiple ascending dose Phase I trial due to commence in 2007 or the filing of a Phase IIa study protocol before 30th June, 2008.
Neuropathic pain refers to pain related to peripheral or central nervous system injury and can persist for months or years after the initial insult. The condition has a poor prognosis and is a significant cause of morbidity. The neuropathic pain market is forecast to reach US$5.5 billion by 2010. Anticipated key drivers of this growth in market size will be the launch of novel drug formulations that will cannibalise older, generic treatment options combined with a large population of diagnosed patients. As current treatments for neuropathic pain offer limited efficacy, it is envisioned that NSL-043 could have a potentially important role in the treatment of this condition.
Commenting on the results Dr Mark Treherne, Chairman of NeuroDiscovery said "Neuropathic pain is a serious medical condition, where there is significant unmet medical need. We are very encouraged by the outcome of the study and believe NSL-043 has the potential to offer an improved treatment option for patients suffering from neuropathic pain. We are also very pleased with how well our collaboration with Sosei continues to progress."
Executive Director David McAuliffe said "It is extremely pleasing to see this project continue to pass through initial regulatory hurdles and, combined with the revenue generation from the NeuroSolutions electrophysiology service business, the Company continues to become further de-risked for investors."
