Tetra Bio-Pharma Inc (TSE:TBP)(OTCQB:TBPMF), a leader in cannabinoid-derived drug discovery and development, on Monday provided shareholders an update on some of its advancing programs.
In a statement, the company said it completed mapping of human cannabinoids and metabolites during the third quarter of 2020, adding that this milestone has a major impact on both its QIXLEEF and CAUMZ drug development programs.
Tetra said knowledge from completing this milestone will also figure prominently in any other THC- or CBD-based products 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.
READ: Tetra Bio-Pharma says ARDS-003 has potential to earn $500M in revenue from royalties, upfront payments by 2026
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.
Tetra said it has entered into a manufacturing agreement with a US-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 while future scale-ups in 2021 will ensure readiness for projected marketing in 2023.
In other developments, Tetra said it 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. Tetra noted that it has the ability to launch its ophthalmic drug program in 2021.
The first deliverables for this milestone were achieved in July 2020. Tetra has 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.
In other news, Tetra recently announced it had signed a definitive agreement with a US-based 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.
"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," said CEO Dr Guy Chamberland.
“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."
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