Medlab Clinical Ltd (ASX:MDC) (Medlab, the Company) is very pleased to announce interim readouts of its Medcare Observational Study, Human Research Ethic Committee (HREC) number 005E_2019, titled “An observational study investigating and auditing the safety, tolerability and further efficacy characteristics of a pharmaceutical-grade cannabis medicine (NanaBis™) that is currently or will be prescribed to eligible patients for the management of cancer-related and non-cancer related pain in general and speciality medical practices.”
By way of summary, 244 doctors attended 1,172 Australian patients and collected data monthly from the start of the study (baseline) to a maximum of 12 months, as appropriate to the patient and their disease condition.
Patients and Doctors were consented to a long-term real-world program with the following outcomes:
• The collection of Adverse Events/Serious Adverse Events that may occur
• Patient withdrawal and reason
• Indication and dosage capture and subsequent changes
• Efficacy in treating pain and quality of life (BPI-SF and SF-12)
• Concomitant medications and changes thereof
• Rationale for dosage/treatment changes
The average duration of NanaBis™ treatment under this study was 5.4 months, with at least 77 patients continuing to receive NanaBis™ post-study completion. The female-to-male ratio was 3:2, with the 36-55 years old and 56-70 years old age ranges comprising 32.5% and 26.0% of all patients, respectively, and representing the two major age segments in the study.
Of the study group:
• 98.5% had chronic pain, 1.5% had acute pain
• 85% had non-cancer pain and 15% had cancer pain
• 55% had a neuropathic component
Pain Severity reduction profiles (Brief Pain Inventory) across the study group showed an average pain reduction of 23% after 6-months of NanaBis™ treatment and a 27% average pain reduction at the 12-month time point.
Patients reported a 55% improvement in Pain Relief after 6 months of NanaBis™ treatment, which was a significantly larger improvement than the 23% reduction in Pain Severity. This could be due to patients increasing activity levels and reducing opioid use because of NanaBis™ treatment.
The cancer-pain patient subgroup showed an average Pain Severity reduction of 25, 33%, 24% and 31% after 1, 3, 6 and 9 months of NanaBis™ treatment and a 49% average Pain Severity reduction at the 12-month time point.
Opioid sparing was demonstrated when NanaBis treatment was given to patients already treated with opioids. Of these patients, 75% were able to decrease opioid use and 60% reduced their opioid use by more than 50%.
Quality of Life (QoL) improvements were reported, specifically in general activity, walking, work, enjoyment of life, sleep, mood, and personal relationships as it relates to pain interference with an average of 31% improvement at 6 months.
In the bone metastasis cancer pain subgroup, 92% of these patients individually improved their pain severity and pain interference (Quality of Life) scores after 6 months of NanaBis™ treatment. This validates the improvements found with average pain severity and average Quality of Life scores in this group, which were 26% improvement and 34% improvement after six months, respectively.
The median dosage was six sprays per day.
Overall, 454 patients withdrew from the study, of which the largest group 33% were lost to follow-up. Only 12.4% of patients experienced a non-serious adverse reaction and 1.3% experienced a serious adverse reaction.
Dr Sean Hall, CEO of Medlab stated, “The value of RWE, if done right cannot be under-estimated, this study demonstrated quantifiable sustainability. It is encouraging to see both patients and prescribers wanting to continue past the 12-month mark, to which we saw similar in the Royal North Shore Hospital trial with advanced cancer, pain patients. In all the interim data demonstrates a good safety, tolerability, and sustainability profile for NanaBis™.”
Dr Jeremy Henson, Director of Research stated, “It is invaluable for us to get data on the real-world use of NanaBis™ from a large number of patients and doctors. These results have confirmed that NanaBis™ provides a safe and tolerable option for pain relief and reduced pain simultaneous with allowing reduced opioid use and increased patient activity. I was especially encouraged that cancer bone metastasis patients, continued to report above average efficacy, which gives us confidence that our pivotal Phase III clinical trial will be a success.”
Next Steps, the Medcare study will relaunch in about March 2023 as the ENHANCE Study, more streamlined and focused on specific data we are wanting to gather. Secondly, July 2023 is approximately when the full readout of this Medcare study is expected.
NanaBis™ is an investigative novel analgesic for cancer patients comprising equal parts of CBD and THC encapsulated in Medlab’s patented delivery platform, NanoCelle®. NanaBis™ is a low-dose cannabinoid-based medicine applied to the oro-buccal membrane (interior of the check) for rapid uptake whilst bypassing 1st pass metabolism, thus avoiding gastrointestinal degradation and reduced viability of the drug substance.
Press release from Medlab Clinical Limited. Note: Content has been edited for style and length.