Australian biotechnology company Medlab Clinical (ASX:MDC) reports it has a favourable readout of its Medcare Observational Study, Human Research Ethic Committee for its pharmaceutical–grade cannabis product, NanaBis.
The company states the study titled ‘An observational study investigating and auditing the safety, tolerability and further efficacy characteristics of a pharmaceutical-grade cannabis medicine that is currently or will be prescribed to eligible patients for the management of cancer-related and non-cancer related pain in general and specialty medical practices’ collected data on the outcomes of NanaBis in patients.
The study was conducted across 1,172 Australian patients by 244 doctors over a 12 month period aiming to test outcomes including adverse events, patient withdrawals, indication and dosage capture, efficacy in treating pain, quality of life, concomitant medications, and rationale for dosage and treatment changes.
Medlab reports the average duration of NanaBis treatment was 5.4 months, with at least 77 patients continuing to receive the drug after completing the study. The female to male ratio for the study was 3 to 2, with the 36-55 year old, and the 56-70 year old cohorts representing 32.5% and 26% of all patients respectively. The company says this represents the 2 major age segments in the study.
Of this cohort, 98.5% reportedly suffered from chronic pain, and 1.5% had acute pain. The majority of this group also reported their pain was not related to cancer, with only 15% suffering from cancer pain.
Medlab reports pain severity reduction profiles 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 the company attributes to increased patient activity levels and a reduction in opioid use.
Furthermore, the cancer pain group patient subgroup demonstrated an average pain severity reduction of 25% after 1 month of NanaBis treatment. This was followed with a 33% reduction at 3 months, 24% at 6 months, and 31% at 9 months.
Commenting on the findings, Medlab Chief Executive Officer Sean Hall says: “The value of RWE (real world evidence), if done right cannot be underestimated, 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.”
Medlab reports 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 also reported in general activity, walking, work, enjoyment of sleep, mood, and personal relationships, which the company attributes to pain interference with an average improvement of 31% at 6 months.
In the bone metastasis cancer pain subgroup, 92% of these patients individually improved their pain severity and pain interference scores after 6 months of NanaBis treatment. Metalab reports this validates the improvements found with average pain severity and average QoL scores in this group.
“It is invaluable for us to get data on the real-world use of NanaBis from a large number of patients and doctors”
Medlab Director of Research Jeremy Henson said: “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 three clinical trial will be a success.”
Medlab reports the median dosage was 6 sprays per day, and overall 454 patients withdrew from the study. Furthermore, the company states only 12.4% of patients experienced a non-serious adverse reaction, and 1.3% experienced a serious adverse reaction.
Medlab reports the Medcare study will relaunch around March as the ENHANCE Study, and also notes a full readout of the study will be conducted in July.
NanaBis is an investigative novel analgesic for cancer patients comprising equal parts of CBD and THC encapsulated in Medlab’s patented delivery platform NanoCelle.
The company says NanaBis is a low-dose cannabinoid-based medicine applied to the inside of the cheek for rapid uptake whilst bypassing first pass metabolism, which avoids gastrointestinal degradation and reduced viability of the drug substance.
Medlab is an Australian biotechnology company focused on developing a range of prescription and non-prescription solutions for therapeutic areas including pain management, mental health, gut health, diabetes, and allergies.