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tbp update

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Tetra Bio-Pharma Provides Update on PPP003 Inflammatory Cytokine Reduction Drug Program
 
by @accesswire on 11 May 2020, 12:03

 OTTAWA, ON / ACCESSWIRE / May 11, 2020 / Tetra Bio-Pharma Inc. ("Tetra" or the "Company") (TSX-V:TBP) (OTCQB:TBPMF), a leader in cannabinoid-derived drug discovery and development, is pleased to announce that its Chief Operating Officer Steeve Nron participated in an interview on Saturday to discuss the Company's development of a drug program to treat certain symptoms of COVID-19.

As mentioned in previous press releases, the Company is developing its already existing initial PPP003 program as a potential intravenous drug as well as a second PPP003 indication for Cytokine Release Syndrome ("CRS") to treat certain symptoms of COVID-19. The CRS program, as mentioned in previous press releases, is intended to treat symptoms from patients who have tested positive for COVID-19. However, the drug is not intended as a vaccine for the prevention of the disease.

Management believes that under an accelerated timeline, a potential drug for CRS could be ready for conditional approval by Health Canada during the third quarter of 2021. This estimated accelerated timeline is based on Health Canada's policy to expedite the review of a drug product shown to improve the outcome of life-threatening conditions, such as COVID-19.

The Company designed the nonclinical safety program and Phase I clinical trial to support Phase II trials in either CRS or ophthalmic disease patient populations. Tetra estimates that this combined program will cost approximately $13.3 million. Only $4.7 million of the announced $18 million will be designated to the Phase II trial in COVID-19 infected patients suffering from CRS.

Tetra has applied to the Federal Government's Strategic Innovation Fund for a grant which would cover approximately 75% of this budget and would allow the Company to meet the accelerated timeline to complete the Phase II clinical trial in the first half of fiscal 2021 and submit for conditional drug approval. The grant application was submitted last week and the process is in early stages with no certainty that a governmental grant will be awarded to the Company. Even if a grant were to be awarded to Tetra, there is no certainty that it would be sufficient to cover 75% of the program as requested by Tetra. Should the Company fail to secure the necessary funding through the Strategic Innovation Fund, the Company would need to raise funds via equity or debt financing, or via other government grants to support the development of the PPP003 Program, which are sources of financing that the Company is exploring at this stage.

The Company is not making any express or implied claims that its product has the ability to eliminate, cure or contain the COVID-19 (or SARS-2 Coronavirus) at this time. As with any new drug candidate, PPP003 has not been shown to be safe or effective in the prevention or treatment of inflammatory cytokine conditions.

About Tetra Bio-Pharma

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