- The Type C meeting with the FDA provides guidance to strengthen QIXLEEF™ nonclinical and toxicological data package for marketing approval.
OTTAWA, ON, March 17, 2022 /PRNewswire/ – Tetra Bio-Pharma Inc. (“Tetra” or the “Company”) (TSX: TBP) (OTCQB: TBPMF) (FRA: JAM1), a leader in cannabinoid-derived drug discovery and development received the response letter for a Type C meeting with the United States Food and Drug Administration (FDA) for its inhaled cannabinoid-based product, QIXLEEF™. The meeting was held to discuss the nonclinical safety requirements for the marketing approval.
Guy Chamberland, CEO and CRO of Tetra Bio-Pharma Inc. commented, “The November 2021 news release confirmed that QIXLEEF™ aerosol, generated by the Mighty Medic® medical device, met the USA cGMP regulatory requirements, including the delivered-dose uniformity (DDU) criteria, established by the FDA for inhalation aerosols. Last month, we announced that preliminary data from over 40 episodes of breakthrough pain in each of the experimental and active treatment groups suggested that QIXLEEF™ could be an effective analgesic for pain management. This new feedback provided by the FDA is very good and will allow the Company to refine its toxicology plan and address the key issues that are of concern to patients who will want to use QIXLEEF™ for a relatively long period of time. The interactions with regulators, like the FDA, are critical for both the Company and shareholders. The FDA guidance will pave the way for marketing approval and allow the Company to elaborate cost-effective strategy as part of the drug development program. To date, our data shows that QIXLEEF™ might become an alternative analgesic to reduce the use of opioids in patients with severe or chronic pain. An alternative to opioids is long overdue.”
The FDA provided guidance on the Company’s nonclinical safety program required to submit a marketing application. Drug metabolite testing in animals is a prerequisite and one of the utmost importance for the FDA is the disproportionate amount of CBD metabolite, 7-COOH-CBD, that was found in humans treated with Epidiolex™ compared to animals. The higher amount of 7-COOH-CBD was correlated to hepatotoxicity raising a safety concern on CBD usage in humans. As previously disclosed, the Company was able to demonstrate that the CBD metabolite, 7-COOH-CBD, is only 2.5 times higher in subjects inhaling QIXLEEF™ compared to 40 times higher in CBD oral administration, thereby supporting a better safety profile for inhaled QIXLEEF™. Additionally, the FDA requires a more exhaustive assessment of brain histopathology as the inhalation route of administration facilitates QIXLEEF™ delivery to the brain. A carcinogenicity assessment is required as QIXLEEF™ is intended to be administered on a chronic basis for long-term usage in patients living with pain. Accordingly, the Company will provide the FDA with a bridging strategy to reduce development costs. The requirements for developmental and reproductive toxicology will also require a bridging strategy to ensure that the risks to patients who are pregnant, at risk of becoming pregnant, or breastfeeding are adequately characterized. Despite the extensive information in the literature, bridging strategies are essential to address specific aspects of a prescription drug as well as to link these findings to existing data. The information received from the FDA will allow the Company to align its nonclinical safety strategy for both the USA and European markets.
About QIXLEEF™
QIXLEEF™ is the Company’s proprietary investigational new drug currently being studied in two FDA authorized clinical trials. QIXLEEF™ is a botanical therapy with a fixed dosage of THC and CBD. The drug is inhaled using a medical vaporizer and manufactured in Canada in a licensed cGMP facility authorized by the Canadian Health Authority.
About REBORN©1 – Clinical Trial
REBORN©1 is a Phase 2 study authorized by U.S. FDA to evaluate inhaled cannabinoids against a class of immediate-release oral opioids for the management of breakthrough cancer pain (BTcP). This is a 10-week proof-of concept, open-label randomized study to evaluate the effect of inhaled QIXLEEF™ as compared to morphine sulfate or hydromorphone or oxycodone for the treatment of BTcP in 20 patients.
About PLENITUDE© – Clinical Trial
Plenitude© is a Phase 2 multicenter clinical trial authorized by U.S. FDA to evaluate the safety and efficacy of inhaled cannabinoids for the uncontrolled pain relief in 78 patients with advanced cancer. It is a 4-week randomized, double-blind, placebo-controlled, parallel group design trial followed by an open label period of 11 months.
About Tetra Bio-Pharma
Tetra Bio-Pharma (TSX: TBP) (OTCQB: TBPMF) (FRA:JAM1) 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: www.tetrabiopharma.com
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Forward-looking statements
Some statements in this release may contain forward-looking information. All statements, other than of historical fact, that address activities, events or developments that the Company believes, expects or anticipates will or may occur in the future (including, without limitation, statements regarding potential acquisitions and financings) are forward-looking statements. Forward-looking statements are generally identifiable by use of the words “may”, “will”, “should”, “continue”, “expect”, “anticipate”, “estimate”, “believe”, “intend”, “plan” or “project” or the negative of these words or other variations on these words or comparable terminology. Forward-looking statements are subject to a number of risks and uncertainties, many of which are beyond the Company’s ability to control or predict, that may cause the actual results of the Company to differ materially from those discussed in the forward-looking statements. Factors that could cause actual results or events to differ materially from current expectations include, among other things, without limitation, the inability of the Company to obtain sufficient financing to execute the Company’s business plan; competition; regulation and anticipated and unanticipated costs and delays, the success of the Company’s research and development strategies, including the success of this product or any other product, the applicability of the discoveries made therein, the successful and timely completion and uncertainties related to the regulatory process, the timing of clinical trials, the timing and outcomes of regulatory or intellectual property decisions and other risks disclosed in the Company’s public disclosure record on file with the relevant securities regulatory authorities. Although the Company has attempted to identify important factors that could cause actual results or events to differ materially from those described in forward-looking statements, there may be other factors that cause results or events not to be as anticipated, estimated or intended. Readers should not place undue reliance on forward-looking statements. The forward-looking statements included in this news release are made as of the date of this news release and the Company does not undertake an obligation to publicly update such forward-looking statements to reflect new information, subsequent events or otherwise unless required by applicable securities legislation.
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SOURCE Tetra Bio-Pharma Inc.
