NDL-101

NDL-101 is a natural product formulation that the Company has been developing as an over-the-counter product for the treatment of pain.

Two Phase II trials have been conducted with this molecule where one of these trials showed the compound prevented pain associated with root planing and scaling, a dental procedure used to combat periodontitis. In the second clinical trial, for the treatment of pain caused by the extraction of wisdom teeth, the Company was unable to measure NDL-101’s efficacy due to unexpected confounding factors.

The results from the periodontitis trial demonstrate that NDL-101 is a highly effective analgesic and was well tolerated. It was found to be equally effective as the local anaesthetic gel currently applied to patients but with the added benefit of no adverse effects.

The proof of concept achieved with the Phase II trial of NDL-101 in periodontitis led to a new patent filing (in the name of NeuroSolutions). This helped to protect the intellectual property position and form an important data package for discussion with third parties.

NeuroDiscovery Ltd has been assigned the 100% ownership of NDL-101 from its 100% owned subsidiary NeuroSolutions Ltd.

The NeuroDiscovery Board is now conducting a strategic review of the programme to determine the best commercialisation path forward. 

NSL-043

During 2008 NSL-043 completed two Phase I clinical trials. In the first trial, healthy participants were given a single, oral dose of between 10 and 2000mg. The highest dose, 2000mg, is five times more than has previously been tested in humans, but NSL-043 was nonetheless well tolerated at all doses, with no safety issues. The second trial tested the safety and tolerability of repeated doses. Healthy participants received 100-2000mg of NSL-043 twice daily for ten days. There were again no safety issues, although some participants on the highest dose experienced mild effects such as tingling and reduced skin sensitivity, which may be consistent with the therapeutic use of NSL-043. The primary goal of these Phase I clinical trials was to establish the safety and tolerability of NSL-043 in humans, which they did successfully.

There was also an important secondary goal that was met. The Company was able to measure the amount of NSL-043 in the blood of participants over time. This pharmacokinetic information is vital for the design of good Phase II efficacy trials. It is particularly important that the concentration of NSL-043 found in participants should overlap with the concentrations that are effective in preclinical models of neuropathic pain. This was observed, representing a mitigation of one of the major risks in clinical development. From 2005 the ownership of the compound had been in a 50/50 joint venture with Sosei Corporation. However in March 2010 the interest in NSL-043 was assigned back to Sosei who now intend to take the compound into Phase II trial/s.

Importantly NeuroDiscovery retains a percentage interest in any commercial outcome that Sosei may achieve with NSL-043. For more details please read the ASX announcement on 17 March 2010.