Medlab’s latest progress report on its ongoing 12-month real-world observational study of cannabinoid treatment NanaBis for cancer-induced bone pain has demonstrated a 55% reduction in pain scores among the patient cohort.
Consistent with the company’s November 2020 update and the results from an earlier Phase I/II study undertaken at Sydney’s Royal North Shore Hospital, the report demonstrated the reduction in pain scores along with significant improvements in quality of life outcomes such as “general activities”, “sleep” and “mood”.
The update is the first to include 119 patients who have completed a six or 12-month observation period.
The company said there was a growing body of real-world and clinical evidence supporting NanaBis for pain therapy including cancer bone pain, paving the way for a Phase III study and US Food and Drug Administration (FDA) drug filing.
A total of 801 (40%) of 2,000 participants have now been recruited to the study, with a 59% female to 41% male gender ratio.
Medlab managing director Dr Sean Hall said: “The results of the latest report continue to support the safety, tolerability and efficacy of NanaBis for pain management in a real-world setting.
“Furthermore, we are encouraged by the growing longitudinal evidence which gives us greater confidence in the quality of data and outcomes reported.
“These latest results further validate NanaBis and strongly supports our clinical pathway and FDA strategy, particularly as we prepare to initiate our IND-approved Phase III study in the US, UK and Australia.”