Tetra Bio-Pharma has reported positive preliminary data from two Phase II clinical trials of its investigational drug, Qixleef, to treat cancer pain.
Qixleef is a botanical inhaled drug that contains a fixed ratio of Tetrahydrocannabinol (THC) and cannabidiol (CBD).
Both trials, REBORN 1 and PLENITUDE, are being carried out across various trial centres in the US.
The ongoing head-to-head, crossover, open-label REBORN 1 trial is analysing the safety and initial efficacy of Qixleef in the development of pain relief and on pain intensity in cancer patients versus three kinds of oral opioids.
Qixleef is evaluated for its potential to manage short and recurrent incapacitating pain episodes (breakthrough pain) in trial subjects.
The oral opioids used in the trial are oral morphine sulfate immediate release, oral oxycodone immediate release and oral hydromorphone immediate release.
The trial findings showed that Qixleef was well tolerated with a favourable safety profile in cancer patients having breakthrough pain.
In addition, no serious adverse events were identified with mild adverse drug-linked reactions reported in the trial.
The randomised, double-blind PLENITUDE trial is evaluating the safety and efficacy of Qixleef in cancer patients with uncontrolled pain.
Initial results confirmed the tolerability and robust safety profile of Qixleef in participants who received either Qixleef or placebo in the randomised double-blind period of four weeks and those who received the therapy during the open-label period of 11 months.
Furthermore, positive effects on pain relief were reported in subjects who were treated with Qixleef.
Tetra Bio-Pharma CEO and CRO Dr Guy Chamberland said: “A safe and efficient therapeutic alternative that allows the reduction of opioids is critical now more than ever to support patients in their journey against pain.
“Preliminary data from both REBORN 1 and PLENITUDE confirm the safety and pharmacodynamic profile of Qixleef reported in the Phase I trials.
“The pharmacokinetic profile of Qixleef is well indicated to help manage short episodes of pain such as breakthrough pain and will offer patients and physicians a viable, safer, and non-opioid option for pain management.”
Health Canada gave positive feedback on Tetra Bio-Pharma’s trial application to assess its drug candidate, ARDS-003, for Covid-19, in March this year.