Australian medical life sciences company, Medlab Clinical (ASX:MDC), has received human ethics approval for the second trial of its patented, cannabis-based medicine, NanaBis.
The company said the trial will follow how Australian doctors use NanaBis, provide patient feedback, and as a result, will provide valuable data aimed at supporting its global regulatory efforts.
It said the cost of the trial will be partly funded by successful participants as they will have access to NanaBis at a significantly reduced price.
According to Medlab CEO, Dr Sean Hall, “This trial is very important to us as it allows MDC to leverage the Australian Special Access Scheme (SAS), follow the patients closely, but more-so publish and use the forth-coming data to bolster all our Regulatory efforts as it relates to NanaBis.”
Dr Hall continued, “In talks with a number of Regulatory bodies, we were offered a unique ability to use this type of data in an effort to diminish the otherwise prescribed number of people needed to finalise drug application work.”
“This trial is happening in parallel to the almost completed Royal North Shore (RNS) trial. With regards to the work at RNS, early data received is very pleasing and this coupled with the learnings from the current Australian SAS usage, NanaBis is a strong contender for pain management and in my mind a viable pain management medication,’ added Dr Hall.
The company said it expects the trial to involve around 2,000 patients across Australia.