Australian biotech Medlab Clinical (ASX: MDC) has reported the first cohort of patients undergoing a 12-month study of its NanaBis cannabinoid treatment for cancer-induced bone pain have registered a dramatic improvement in their pain scores.
An interim analysis of 119 patients who have completed six and 12-month administration of the drug has showed a 55% reduction in pain scores, with significant quality of life improvements also reported in the areas of sleep, mood and general activities.
It is the fifth monitoring report on the 12-month study and complements results from earlier Phase I and Phase II studies undertaken at the Royal North Shore Hospital in New South Wales.
Medlab has recruited almost 40% (801 people) of a total 2,000 participants into the observational study, ranging in age from 21 years to 99 years with females representing 59% of the intake.
Of those with cancer-related pain, approximately 3% presented with cancer-induced bone pain. Of the total patient population, 99% registered with chronic pain and 1% have acute pain.
Preliminary analysis of patient Brief Pain Inventory (BPI) scores after six and 12 months showed improvement in mean (SE) pain scores from 6.5 (0.2) at the commencement of the study; to 5.5 (0.4) at six months; and 4.7 (0.6) at 12 months.
Of the 119 patients (65% female; 35% male) who have completed six and 12-month courses of NanaBis, approximately 50% had muscular or neuropathic pain; 32% had soft tissue pain with muscular pain; 11% had visceral pain; and 7% registered “other categorised pain”.
Safety and tolerability
Medlab managing director Dr Sean Hall said reports from prescribing doctors showed NanaBis continues to conform to safety and tolerability expectations.
“The results support the safety, tolerability and efficacy of NanaBis for pain management in a real-world setting [and] this remains consistent with the growing body of clinical and real-world evidence supporting the drug,” he said.
“We are [also] encouraged by growing longitudinal evidence which gives us greater confidence in the quality of data and outcomes reported,” Dr Hall added.
Developed as a non-opioid alternative for the treatment of cancer-induced bone pain, NanaBis is an equimolar formulation comprising tetrahydrocannabinol (THC) and cannabidiol (CBD).
The ingredients have been optimised for use as a sub-micron (nano-sized) nanoparticle drug for ease of administration using Medlab’s proprietary drug delivery platform NanoCelle.
Last week, Medlab announced the European Patent Office’s intention to grant a patent covering the use of NanoCelle in European member states as well as the UK until 2036.
Real world evidence
The NanaBis observational study was launched in December for the purpose of gathering real world evidence to accompany clinical data supporting the drug’s efficacy.
It is expected the total number of patients required for the study may be reduced, potentially reducing the time, cost and duration of clinical trials required for regulatory approval.
Dr Hall said the latest results support Medlab’s clinical pathway and US Food & Drug Administration (FDA) strategy, and paves the way for the launch of a Phase III study in the United States, United Kingdom and Australia, approved under the US FDA’s Investigational New Drug program.
Cancer bone pain
Cancer-induced bone pain is a neuropathic pain by medical definition and is degenerative in nature.
According to Medlab, it impacts about 700,000 new patients in the US, Australia and Canada each year.
The global market for the bone pain management is estimated to be $1.58 billion and growing.