Chronic pain treatment developer Medlab Clinical (ASX.MDC) has received positive feedback from the ongoing 12 month observation study of NanaBis, a cannabinoid treatment for cancer-induced bone pain and its progress towards a global Phase III study to commence in 2021.
Consistent with the previous results from the earlier Phase I/II study undertaken at the Royal North Shore Hospital, the fourth monitoring report on the 12 month observational study of NanaBis has demonstrated a 55% reduction in pain scores. The study report is also indicating significant improvements in specific quality of life outcomes such as “general activities”, “sleep” and “mood”.
The study, which was formally launched in 2020, has now enrolled 668 participants from a target of 2,000 (33.5% recruited), of these 16% of participants are in cancer-related pain and 84% are in non-cancer related pain. Of those with cancer-related pain, 3% have cancer bone pain. 99% of participants have chronic pain and 1% have acute pain.
NanaBis is a highly purified blend of THC:CBD, which has been optimised for use at sub-micron (nano-sized) doses using Medlab’s proprietary drug delivery platform, NanoCelle. It is being developed as non-opioid alternative for the treatment of cancer-induced bone pain.
Managing Director, Dr Sean Hall, said the purpose of the Observational Study is to provide Real World Evidence (RWE). With a body of clinical and real world evidence in hand, it is expected that the total number of patients required in clinical trials required for the regulatory approval for NanaBis could be reduced, thus possibly reducing the time, cost and duration of clinical trials required for approval. The observational study was initiated following discussions with the US Food and Drug Administration (FDA) regarding the pathway to regulatory approval.
We continue to be encouraged by the pace of enrolment in the study and the positive results, which are consistent with our existing clinical data,” Dr Hall said.
“Not only does the study help us to build a base of prescribers and patients for NanaBis who can access this drug under Special Access Scheme, it supports our ultimate goal of achieving US regulatory approval for NanaBis as a treatment for cancer- induced bone pain.
“There is an urgent need to provide a viable alternative to opioids for the treatment of cancer-related pain – and ultimately chronic pain in general. The strong body of evidence we are collecting, the scientific quality of our product and the progress we are making towards a global Phase III study differentiates us from other medicinal cannabis plays.”
The company has prepared the first of its Investigational New Drug (IND) submissions to the US Food and Drug Administration (FDA), for approval of NanaBis use in connection to the study. This submission has been prepared taking into account feedback from ongoing dialogue with the FDA.
“Acceptance of the IND(s) will be important milestones, enabling us to move forward with the study but also providing validation from the regulator of the merit of our safety, quality and clinical data collected to date,” concluded Dr Hall.
The company anticipates several IND approvals, allowing for both compassionate US use and clinical investigation.