Tetra Bio-Pharma Provides Update on Recent Milestones
- Plenitude Trial initiated
- Tetra completes clinical study assessing the metabolism profile of cannabinoids in humans
- Achieved development of ARDS-003 sterile injectable nano-emulsion for human use
OTTAWA, ON / ACCESSWIRE / November 16, 2020 / Tetra Bio-Pharma Inc. ("Tetra" or the "Company") (TSX:TBP)(OTCQB:TBPMF), a leader in cannabinoid-derived drug discovery and development, today provided an update on its ARDS-003, CAUMZ™, PPP-003 (ophthalmic) and QIXLEEF™ programs.
At its June 2020 Annual General Meeting (AGM), Tetra announced it was planning to complete the following milestones in 2020:
- Complete mapping of cannabinoid metabolites;
- Initiate Reborn© trial with CAUMZ™;
- Finalize commercial readiness - manufacturing scale-up for CAUMZ™;
- Complete IND-enabling nonclinical safety studies of its COVID-19 drug, ARDS-003;
- Initiate the Phase 1 study for ARDS-003;
- Initiate the Phase 2 study for ARDS-003;
- QIXLEEF™ drug supply and study initiation.
Milestone - Complete mapping of human cannabinoids and metabolites:
Tetra completed this especially important milestone during Q3 2020. This milestone has a major impact on both QIXLEEF™, CAUMZ™. Knowledge from completing this milestone will also figure prominently in any other THC- or CBD-based product that Tetra will develop, as it defines the metabolite profile of cannabinoids administered by inhalation. It demonstrated the ability of Tetra's inhalation technology to quickly deliver significantly higher levels of these cannabinoids to the brain and showed a profile favoring liver safety.
Milestone - Initiate Reborn© trial:
At its AGM, Tetra shared the rationale for making Reborn© the priority over Serenity©. Reborn© is designed to be able to demonstrate the ability of inhaled cannabinoids to reduce the use of opioids in patients suffering from breakthrough pain, which represents a major scientific milestone. Tetra has shown that inhalation achieves very rapidly maximum plasma concentrations of THC in humans. Furthermore, this peak level in the blood is associated with the peak of the pharmacodynamic effect. Tetra has hypothesized that achieving this pharmacodynamic effect within 5 to 10 minutes in patients will provide significant relief through a dissociation mechanism. Consequently, by increasing a patient's tolerance to pain, physicians will be able to reduce the overall dosage of opioids.
The Reborn© clinical trial was designed with two parts. A first part is aimed at testing the hypothesis and helping to determine the required sample size to demonstrate superiority. The second part is aimed at comparing the speed of onset of pain relief to that of a fast release morphine formulation.
Tetra previously announced the ability to manufacture GMP grade QIXLEEF™. Tetra maintains its milestone related to the submission of the Reborn© trial. However, this trial will first be performed with QIXLEEF™ and subsequently with CAUMZ™. Both CAUMZ™ and QIXLEEF™ deliver to patients the same amount of THC, CBD, and other minor cannabinoids via inhalation. The outcome of this study will scientifically apply to both drugs.
As the Company continues to advance CAUMZ™ and QIXLEEF™ towards the ultimate milestone of marketing approval, Tetra plans to initiate Phase 3 and NDA-filing (New Drug Application) enabling toxicology for both drugs. In addition, Tetra plans to initiate research studying the THC-CBD interactions required for the NDA as well as a trial in advanced cancer patients.
Milestone - Finalize commercial readiness - manufacturing scale-up:
COVID-19 has had an impact on Tetra's original plans to implement the Vitiprints technology at its facility. As an alternative, and to keep with plans to accelerate CAUMZ™ in 2021, Tetra entered into a manufacturing agreement with a USA-based cannabinoid drug manufacturer for the manufacturing and scale-up of CAUMZ™. With this agreement in place, Tetra can supply the GMP pharmaceutical CAUMZ™ for its 2021 clinical trials and future scale-ups in 2021 will ensure readiness for the projected marketing in 2023.
Milestone - Complete IND-enabling nonclinical safety of ARDS-003:
Tetra continues to project completion in 2020 of the toxicology studies required to initiate the CTA/IND process for the Phase 1 clinical study and to pursue the development of ARDS-003, a drug for COVID-19.
This milestone will also provide a solid nonclinical safety package for Tetra's ophthalmic drug program (PPP-003). What will remain will be to assess the local tolerance of the eye product formulation and degree of systemic absorption in animals. This clearly defines Tetra's ability to launch its ophthalmic drug program in 2021.
Milestone - Initiate the Phase 1 & 2 studies for its COVID-19 drug ARDS-003:
The first deliverables for this milestone were achieved in July 2020. As previously announced, Tetra successfully completed the development and validation of intravenous nano-emulsion sterile formulation for human trials. In July, the Company initiated the set-up of the Phase 1 trial, and in September the activities were launched to set-up the Phase 2 trial.
Milestone - QIXLEEF™ drug supply and study initiation:
Earlier this year, Tetra announced the shipment of the drug by Aphria and confirmed that the in-life phase of the Plenitude© clinical trial activities had been initiated.
In August 2020, Tetra announced it intended to submit the Plenitude II© clinical trial as a Phase 3, initiating the study in Malta. This announcement was made after completing a meeting with a European Competent Authority, Malta Medicines Authority. The Company initiated principal investigator and site selection activities and continues to progress on the implementation of Tetra Bio-Pharma Europe LTD. Tetra plans to initiate the preparation of the European clinical trial application in 2020.
Additional Achieved Milestone - Dronabinol NDS filing:
Tetra recently announced it had signed a definitive agreement with a USA strategic partner providing the Canadian exclusive rights for Dronabinol soft gel capsules. Tetra was in discussions with a pharmaceutical company for 15 months to obtain the rights. Tetra maintains its plan to submit its first new drug submission (NDS) to obtain approval and the drug identification number (DIN) for a THC-based prescription drug in 2020.
Dr. Guy Chamberland, CEO and CRO commented, "When the COVID-19 pandemic hit, Tetra and its Board of Directors assessed all of its operational plans to ensure it would deliver on key value creating milestones for shareholders. Although 2020 is not over, to date, we have completed many important milestones that undoubtedly increased Tetra's value as a drug development company. We even delivered an extra milestone by acquiring the Canadian exclusive rights for Dronabinol. We also assisted other companies dedicated to the fight against COVID-19 by providing regulatory and quality/compliance pro-bono services to deliver masks and disinfectant products to Canadians.
He added, "Tetra modified the membership of the Board of Directors as it prepared for reaching a key inflection point in its growth. We also added key people to Tetra's senior management to ensure Tetra had a solid experienced team in drug development. These achievements were critical to demonstrate that Tetra had all the components required to deliver what the Company promised to the market. With this team, Tetra maintains its plans to submit its first drug marketing application in 2020 (THC-based drug NDS) as well as submitting a New Drug Application for other prescription drugs in 2021, 2022 and 2023."
About Tetra Bio-Pharma
Tetra Bio-Pharma (TSX:TBP) (OTCQB:TBPMF), is a biopharmaceutical leader in cannabinoid-based drug discovery and development with a FDA and a Health Canada approved clinical program aimed at bringing novel prescription drugs and treatments to patients and their healthcare providers. Our evidence-based scientific approach has enabled us 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 we 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
Neither the TSX Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Exchange) accepts responsibility for the adequacy or accuracy of this release.
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.
For further information, please contact Tetra Bio-Pharma Inc.:
Tetra Bio-Pharma Inc
Dr. Guy Chamberland, M.Sc., Ph.D.
Chief Executive Officer
Phone: + 1 (833) 977-7575
Alpha Bronze, LLC
Mr. Pascal Nigen
Phone: + 1 (646) 255-0433
Ms. Carol Levine APR, FCPRS
Phone: + 1 (416) 425-9143 ext. 226
Mobile: + 1 (514) 703-0256
SOURCE: Tetra Bio-Pharma
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