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Little Green Pharma (ASX: LGP) is pleased to advise analysis of initial results from the award- winning1, QUEST Initiative has found significant improvements in overall HRQL, fatigue levels as well as improvements in anxiety, depression and pain among Australian patients who have been part of the medicinal cannabis study during the initial three-month period.

The QUEST Initiative, sponsored by LGP, was one of the world’s largest longitudinal clinical studies investigating the effect of medicinal cannabis on patient quality.

The study was also supported by not-for-profit private health insurance provider Health Insurance Fund of Australia (HIF) and guided by an experienced advisory group and endorsed by a range of national bodies, such as MS research Australia, Chronic Pain Australia, Arthritis Australia and Epilepsy Australia.

Overview

Adult patients in Australia who were newly prescribed medicinal cannabis for health conditions – including chronic pain, fatigue, sleep, depression and anxiety – between November 2020 and December 2021 were invited to participate in the study.

Participants completed a questionnaire before starting medicinal cannabis treatment and then subsequent questionnaires two weeks after commencing treatment, and every 1 – 2 months thereafter for up to one year.

Overall, 2,327 Australian patients aged between 18 to 97 years (average 51 years) participated in the study of which 63% of overall participants were female. Patients were recruited across six states by 120 independent doctors, a point of difference to the study.

The most-reported conditions being treated were chronic pain (69%); sleep disorders (23%); anxiety (22%); and anxiety/depression (11%); half of patients were being treated for more than one condition.

Results

Results from the first three-months of patients using medicinal cannabis found there was very strong evidence (p<0.001) of clinically meaningful improvements in HRQL and fatigue across all health conditions assessed.

“Clinically meaningful results” in a study refer to findings that have a significant and important impact on a person’s health or well-being. These results are not just small or insignificant changes; instead, they are substantial and can make a real difference in how healthcare professionals understand or treat a medical condition.

Patients also reported clinically meaningful reductions in pain and significant improvements for moderate-severe anxiety and depression.

However, three-month results for those patients assessed for sleep disorders found no change despite the very strong evidence of statistical improvement in feelings of fatigue. It is worth noting that these findings reflect the grouping of all medicinal cannabis oil formulations used by participants and that further analysis of the 12-month findings will seek to identify whether specific product formulations had differing impact on sleep.

These outcomes hold substantial clinical significance, particularly given the strict eligibility criteria for medicinal cannabis prescription in Australia, where patients must have exhausted conventional treatment options. It is remarkable for a single medication to exhibit a positive impact on treatment- resistant patients across such a broad range of medical conditions

“The QUEST results show that medicinal cannabis provides statistically, and more importantly, clinically significant improvements in pain levels, fatigue and quality of life for patients. Doctors can have confidence in offering medicinal cannabis treatment as an option to those who qualify for it as result of emerging real-world data provided by initiatives such as QUEST,” Dr. Jamie Rickcord, an independent General Practitioner involved in the QUEST Initiative, said.

Next steps

Analysis of 12-month results is currently being undertaken to see if improvements are maintained over the longer term. In addition, due to the positive findings of this study, a new investigation called the Global QUEST Initiative is recruiting patients to determine the health economic impact of medicinal cannabis.

Commenting on the three-month findings, Little Green Pharma Head of Research & Innovation Dr Leon Warne said:

“Little Green Pharma is extremely proud to support this significant study into the effect of medicinal cannabis on patient quality of life.

“These initial results are highly encouraging, highlighting meaningful improvements in health-related quality of life and fatigue levels as well as improvements to health conditions associated with anxiety, depression and pain among Australian patients who participated in the study.

“As well as the medical benefits to patients, this study was able to provide access to experienced prescribers and more affordable medication.

“We now look forward to what the 12-month results show in terms of longer-term impact of medicinal cannabis on QUEST patients.”

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