MedLab reports good interim readouts on NanaBis, gives confidence for Phase III trial
Health & Biotech
Health & Biotech
Medlab says the study demonstrated a good safety, tolerability, and sustainability profile for its lead drug, NanaBis.
Medlab (ASX:MDC) has just announced favourable interim readouts of its NanaBis real world evidence (RWE) Medcare Observational Study.
NanaBis is an investigative novel analgesic for cancer patients comprising equal parts of CBD and THC encapsulated in Medlab’s patented delivery platform, NanoCelle.
It is a low dose cannabinoid-based medicine applied to the interior of the cheek for rapid uptake whilst bypassing 1st pass metabolism, thus avoiding gastrointestinal degradation and reduced viability of the drug substance.
The full study readout is expected in July, but the following is a summary of the interim results.
In the study, 244 doctors attended 1,172 Australian patients and collected monthly data to a maximum of 12 months, as appropriate to the patient and their disease condition.
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. This range represents the two major age segments in the study.
The patient cohorts include:
The median dosage of NanaBis administered to these patients was six sprays per day.
Results showed that Pain Severity profiles across the cohorts had an average pain reduction of 23% after 6-months of NanaBis treatment. At the 12-month time point, 27% average pain reduction was detected.
Patients also reported a 55% improvement in Pain Relief after 6 months of NanaBis treatment.
The cancer-pain patient subgroup meanwhile showed an average Pain Severity reduction of 25% after 1, 3, 6 and 9 months of NanaBis treatment, and a 49% average Pain Severity reduction at the 12-month time point.
In the bone metastasis cancer pain subgroup, 92% of patients individually improved their pain severity and pain interference scores after 6 months of NanaBis treatment.
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.
During the study, 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%.
Dr Sean Hall, CEO of Medlab said that the value of RWE, if done right, cannot be under-estimated and 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.”
During the study, Quality of Life improvements were also reported – specifically in general activity, walking, work, enjoyment of life, sleep, mood, and personal relationships as it relates to pain interference with an average 31% improvement at 6 months.
“It is invaluable for us to get data on the real-world use of NanaBis from a large number of patients and doctors,” said Dr Jeremy Henson, Medlab’s Director of Research.
“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 3 clinical trial will be a success.”
The next step will see the Medcare study relaunch in around March as the ENHANCE Study, a more streamlined and focused study on specific data points.
This article was developed in collaboration with MedLab Clinical, a Stockhead advertiser at the time of publishing.
This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.