NeuroDiscovery Ltd (ASX: NDL) a neurology focused research and development company, has completed two parallel Phase IIa clinical trials of NSL-101 for two different dental surgery applications. The novel NSL-101 natural product formulation was highly effective in the treatment of pain associated with root planing and scaling, a painful procedure used to combat periodontitis. In a further parallel clinical trial for the treatment of post-operative pain caused by the extraction of impacted third molars (“wisdom teeth”) the Company was unable to clearly demonstrate NSL-101’s effects due to unexpected confounding factors. The results from the periodontitis trial demonstrate that NSL-101 is an effective analgesic preparation and this proof-of-concept data significantly enhances the value of this clinical asset. These results have led to a new patent filing to protect the Company’s intellectual property position.
The periodontitis study compared the analgesic efficacy and safety of NSL-101 gel with a local anaesthetic, which is the gold standard for pain prevention during scaling and root planing. This procedure is used to treat moderate to severe periodontitis, and is typically associated with significant pain. NSL-101 was highly effective and well tolerated. It was found to be equally effective as the local anaesthetic gel, and no adverse effects were reported. Further details of the trial are contained in the appendix.
The second parallel study was unable to evaluate the analgesic efficacy of NSL-101 compared with placebo in patients after the extraction of one or more impacted wisdom teeth. The duration of the local anaesthetic used during surgery was longer than expected, thus potentially masking any analgesic effects of NSL-101 and compromising the outcome of the study. The study was designed to ensure that patients would not experience severe pain at any time and NSL-101 was found to be well tolerated.
Based on the successful proof-of-concept data that the topical application of NSL-101 can effectively prevent the perception of pain, NeuroDiscovery has filed a new patent describing the preparation, formulation and use of NSL-101. NeuroDiscovery is currently seeking an appropriate out licensing and/or collaborative partner who will receive the rights to market this product.
Dr Iain Chessell, CEO of NeuroDiscovery, commented, “We are delighted to have demonstrated the effectiveness of NSL-101. This exciting new treatment has many over-the-counter applications.”
Dr Mark Treherne, Chairman of NeuroDiscovery added, “There are significant commercial opportunities for new additions to toothpastes, ulcer gels, toothache remedies, as well as creams and ointments for stings and grazes. NSL-101 may also have future commercial applications following minor cosmetic procedures. NSL-101 is an opportunity to differentiate our products from those of our competitors, and these new data could well provide us with a significant commercial advantage. Furthermore, the results from the periodontitis trial demonstrate our ability to identify treatments that work in the clinic.”
