Tetra Bio-Pharma Announces Positive Initial Clinical Data from Both of its Ongoing Phase 2 Clinical Trials of QIXLEEF™

Tetra Bio-Pharma Inc. a leader in cannabinoid-derived drug discovery and development today announced positive initial clinical data from its ongoing Phase 2 clinical trials (REBORN^©1 and PLENITUDE^©) of QIXLEEF™ for cancer pain. QIXLEEF™ is a botanical inhaled investigational new drug with a fixed ratio of THC and CBD that meets USA cGMP regulatory requirements.

The REBORN^©1 trial is a head-to-head, open-label, crossover phase 2 study against oral opioids in the management of short and frequent episodes of incapacitating pain (breakthrough pain) in patients with cancer. The REBORN^©1 study protocol is assessing the safety and preliminary efficacy of QIXLEEF™ in onset of pain relief and on pain intensity compared to three types of immediate release oral opioids: oral morphine sulfate immediate release, oral hydromorphone immediate release, and oral oxycodone immediate release. The PLENITUDE^© trial is a randomized double-blind phase 2 study assessing the safety and efficacy of QIXLEEF™ in patients with cancer who have uncontrolled pain. Both studies are conducted across multiple clinical sites located in the United States.

Safety data of the REBORN^©1 trial collected up to now confirm QIXLEEF™ tolerability and good safety profile in patients with cancer with breakthrough pain; no serious adverse events have been reported, only adverse drug reactions of mild intensity have been recorded. Preliminary data of the PLENITUDE^© trial also confirm QIXLEEF™ tolerability and good safety profile in the pool of subjects treated with either QIXLEEF™ or the placebo in the randomized double-blind 4-week period and in subjects treated with QIXLEEF™ during the open-label 11-month period. Preliminary analysis of the data shows a positive effect on pain relief in QIXLEEF^TM-treated patients. The Company cannot disclose further data on efficacy due to regulatory compliance.

Dr. Guy Chamberland, CEO and CRO commented, “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.”

Lastly, Tetra’s metabolite profile study in humans showed that intake of QIXLEEF™ does not lead to significant levels of metabolites associated with toxicity and its pharmacokinetic profile mirrors the temporal characteristics of breakthrough cancer pain episodes, with a transient and fast effect of action. Tetra’s Phase I trials showed that maximal plasma concentration was reached within 5 minutes and that the drug was well tolerated with a good safety profile.

About Breakthrough Cancer Pain

Opioids are the cornerstone of the management of cancer pain. The opioid crisis is serious, and the number of deaths related to overdosing remains elevated (Opioid Basics | CDC’s Response to the Opioid Overdose Epidemic | CDC). Tetra’s cannabis and cannabinoid-derived product pipeline has the potential to play a significant role in opioid use reduction, thus addressing a societal issue of critical proportion.

Current opioids approach to manage breakthrough pain are inadequate to timely relieve pain in patients with cancer. Immediate-release oral morphine produces an analgesic effect in 30-45 minutes, with peak effect at ~1 hour or more (Staahl C. et al., Journal of Clinical Pharmacology, 2008; 48:619-631), in contrast to episodes of breakthrough cancer pain, which typically peak within 3-15 minutes and last ~1 hour. In addition to inappropriate time window of efficacy, immediate-release oral opioids affect the patient’s functioning (e.g., confusion) and quality of life (e.g., constipation, drowsiness, sleep disorders) and may induce life-threatening side effects such as respiratory depression in addition to multiple side effects. More potent opioids such as fast-onset opioids have a higher risk of abuse potential, increasing the risk of misuse and overdose. There is currently no therapeutic solution that offers fast onset of pain relief with an acceptable safety profile and low risk of abuse potential.

About Tetra Bio-Pharma

Tetra Bio-Pharma is a leader in cannabinoid-derived drug discovery and development with a FDA and a Health Canada cleared clinical program aimed at bringing novel prescription drugs and treatments to patients and their healthcare providers. Their evidence-based scientific approach has enabled them to develop a pipeline of cannabinoid-based drug products for a range of medical conditions, including pain, inflammation, and oncology. With patients at the core of what they do, Tetra Bio-Pharma is focused on providing rigorous scientific validation and safety data required for inclusion into the existing biopharma industry by regulators, physicians and insurance companies.

For more information visit: www.tetrabiopharma.com

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