Cymra completes Musculoskeletal Chronic Neck and Back Pain Phase II study
Clinical Development Program
Medical
Cymra has now COMPLETED its Phase II Dose Escalation Study
This open label Phase II dose-ranging study has been conducted to demonstrate the safety and tolerability of oral administration of Cybis oil in patients with moderate to severe chronic back or neck pain unresponsive to over-the- counter (OTC) analgesics.
The study also investigates the dose-response relationship of Cybis 10:25 oil in terms of pain relief and quality of life outcomes in this patient population and examines the pharmacokinetics of Cybis 10:25 oil after single and repeat dose
GMP Australian grown and manufactured cannabis oil
The clinical product, Cybis 10:25 oil is a formulated full spectrum medicinal cannabis product. The product is manufactured in Australia under GMP conditions.
The product consists of two cannabis strains for CBD and THC
It is also EU GMP compliant
Methods
Twenty-eight patients with moderate to severe chronic back and neck pain unresponsive to OTC analgesics have completed the four-week dosing period.
Doses of CybisTM 10:25 oil will increase weekly in all patients from 0.5 mL once daily to 0.5 mL twice daily, 1.0 mL twice daily, and 1.5 mL twice daily, as tolerated.
Patients are assessed at the end of each one-week dose period for safety and tolerability with a physical examination and recording of adverse effects. Pain response, depression / anxiety / stress, sleep quality, and overall treatment satisfaction are also assessed at the end of each dose period using validated assessment tools.
Pharmacokinetic analyses are undertaken after the first dose, and after the last dose at each dose level.
The results of the study demonstrate the safety of Cybis 10:25 oil in this population and provide information on the dose response relationship of Cybis 10:25 oil to support dose selection and calculation of patient numbers for a pivotal Phase III randomised controlled trial to be commenced in 2024
Results
Results have been published in a peer reviewed journal
Reduction in pain scores
Cymra has statistical significance at all dose levels
Clear dose response
Minimal adverse effects
Understanding of bioavailability, toxicity and safety data
Improvements in quality of life
Next steps
Cymra has developed a Phase III clinical trial protocol
Over 200 patient study double blinded placebo controlled study
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