Clinical Trials

Ongoing clinical trials and real-world patient data collection are critical to the development of our range of proprietary products and to accelerate the path to regulatory approval

Autism

Autism spectrum disorder (ASD) affects approximately 1 in 150 Australians, with its prevalence growing at a faster rate than any other disability.1

Unlike conventional treatments, cannabinoid-based medicines can help alleviate the core symptoms of autism because they mimic the naturally occurring compounds in our body’s endocannabinoid system (ECS).

The ECS is a major physiological regulator of chemicals in our brain and throughout our body, particularly the gut and immune system. It acts as a neuromodulating network to regulate emotional responses, behavioural reactivity and social interactions.

One such compound is called Anandamide, that our bodies make in response to stress or injury. Children with autism have lower concentrations of this chemical and can’t respond to the stress. If there’s a deficiency, suggesting a dysfunctional ECS, the pharmacologic potential of cannabinoids to treat the symptoms and comorbidities of autism is significant.

A study by Kuester et al. 2017 found treatment with cannabinoid-based medicine was significantly more effective than with conventional treatments for autism and well tolerated overall.

To date there have been six studies with over 300 patients involved in our clinical trials. Zelira has brought to market a range of proprietary products that were developed in consultation with the Autism community to address ongoing unmet needs. We have conducted observational trials in the USA and currently have an Australian trial recruiting patients now.

ZTL-101 Improved Insomnia Severity (Insomnia Severity Index (ISI) Scores)

  • ISI scores significantly improved following ZTL-101 treatment vs placebo at all doses.
  • High dose of ZTL-101 achieved a 36% reduction in ISI scores.
  • High dose of ZTL-101 saw people move from ’Moderate Severity’ to ‘Sub Clinical’ clinical insomnia.

References:
Statistical significance calculated using adjusted means for low dose subgroup (ZTL-101 vs placebo-18.7 ISI) and high dose subgroup (ZTL-101 vs placebo- 17.4 ISI). *p<0.05, **p<0.005.

ZTL-101 Improved Objective Measures Of Sleep (Actigraphy)

Responses improved with increasing dose

ZTL-101 vs
Placebo
Total Sleep Time
(min)
Sleep Efficiency
(%)
Wake After Sleep Onset
(min)
Sleep Onset Latency
(min)
Low dose
(n=11)
28* 2.61 9.52 0.25
High dose
(n=12)
42** 3.57** ↑ 12.31 1.19*
Average 33** 2.89** 10.17* 0.41

 

Relative to placebo, ZTL-101 significantly:

  • Increased the time people spent asleep
  • Decreased the amount of time people spent awake during the night

Definitions:
Total Sleep Time (TST): Total amount of time spent asleep over the night. Sleep Efficiency (SE): Proportion of the time spent asleep during the night relative to the time spent in bed trying to sleep. Wake After Sleep Onset (WASO): Amount of time spent awake after sleep onset. Sleep Onset Latency (SOL): Time taken to fall asleep at the start of the night.

References:
Statistical significance calculated using adjusted means for ZTL-101 vs placebo. * p ≤ 0.05, ** p≤ 0.001

ZTL-101 Improved Subjective Measures Of Sleep (Patient Sleep Diaries)

Responses improved with increasing dose

ZTL-101 vs
Placebo
Total Sleep Time
(min)
Rating of Quality of Sleep
(1-5)
Rating of how rested people felt upon waking
(1-5)
Sleep Onset Latency
(min)
Low dose
(n=11)
60* 0.53* 0.26 10.2
High dose
(n=12)
78** 0.98** 0.75** 10.5
Average 65** 0.74** 0.51* 8.5*

 

Relative to placebo, ZTL-101 significantly:

  • Increased the time people thought they spent asleep
  • Improved the quality of sleep people felt they had
  • Improved how rested people felt on waking

References:
Statistical significance calculated using adjusted means for ZTL-101 vs placebo. * p ≤ 0.05, ** p≤ 0.001

ZTL-101 Improved Quality of Life (Subjective Questionnaires)

ZTL-101 vs
Placebo
Multidimensional Fatigue Inventory
General Fatigue 1 Mental Fatigue 1 Total Fatigue 1
Work and Social Adjustment Scale
Home Management 2 Total WSAS 2
Low dose
(n=11)
28* 2.61* 9.52 0.25 0.25
High dose
(n=12)
1.38 1.0 3.63 0.63* 2.13
Average 1.57** 1.37* 3.71* 0.6* 2.2*

 

Relative to placebo, ZTL-101 significantly:

  • Reduced total fatigue – particularly mental fatigue
  • Improved the ability of people to function – particularly the ability to manage the home

References:
Questionnaires: 1. Multidimensional Fatigue Inventory, 2. Work and Social Adjustment Scale (WSAS), Statistical significance calculated using adjusted means for ZTL-101 vs placebo. * p ≤ 0.05, ** p≤ 0.001

Chronic pain

Chronic pain affects 1 in 5 Australians aged 45 and over. It’s a common and complex condition characterised by persistent pain on most days of the week3

The conventional treatment for chronic pain is prescription opioids, but these medications have serious side-effects including physical adherence. The growing number of people with opioid addiction comes with a high mortality rate that has clinicians looking for a non-drug treatment to reduce this global epidemic.

In Australia, the rate of accidental deaths due to opioids has doubled for people aged 35 to 44 since 2007, with more than two-thirds of these deaths due to pharmaceutical opioids3.

Zelira believes there’s clear potential to use cannabinoids to reduce the use of opioids in patients requiring chronic pain management. We’re expanding our portfolio of cannabinoid-based products that target chronic pain.

References

  1. A snapshot of Autism in Australia https://australianautismalliance.org.au/autism-snapshot-2/
  2. Chronic insomnia disorder in Australia. Sleep Health Foundation https://www.sleephealthfoundation.org.au/news/special-reports/chronic-insomnia-disorder-in-australia.html
  3. Chronic pain in Australia. Australian Institute of Health and Welfare May 2020; https://www.aihw.gov.au/reports/chronic-disease/chronic-pain-in-australia/contents/summary

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