leadf
logo-loader
viewTetra Bio-Pharma

Tetra Bio-Pharma clears path to human trials of potential coronavirus treatment ARDS-003 after completion of safety studies

The safety studies were necessary to submit a clinical trial application in Canada and an investigational new drug application in the US for a Phase I study in humans

Tetra Bio-Pharma -
Tetra’s program included general toxicology studies in two species as well as specific studies to assess toxicity in major organ systems as well as genotoxicity

Tetra Bio-Pharma Inc (TSE:TBP) (OTCQB:TBPMF) announced Wednesday that it has completed toxicology studies on its novel drug candidate ARDS-003, clearing the path for human clinical trials.

Derived from cannabinoids, ARDS-003 is designed to prevent and treat acute respiratory distress syndrome (ARDS), a severe inflammatory response that could be life-threatening to patients with coronavirus (COVID-19) or sepsis.

Tetra’s program included general toxicology studies in two species as well as specific studies to assess toxicity in major organ systems as well as genotoxicity.

READ: Tetra Bio-Pharma tells shareholders its advancing several treatment programs aimed at cancer and COVID-19

The toxicology studies included single dose pharmacokinetics, maximum tolerated dosages, seven-day dose range finding and 14-day repeat dose toxicity with toxicokintetics and recovery in rodent and non-rodent species.

Safety pharmacology and other toxicology studies include cardiovascular study in conscious dogs as well as respiratory and central nervous system assessment in rodents.

The safety studies were necessary to submit a clinical trial application in Canada and an investigational new drug (IND) application in the US for a Phase I study in humans.

'Critical step'

Tetra’s CEO Guy Chamberland called the news “an exciting and critical step” in the development of ARDS-003.

“As few as 1 out of 1,000 compounds cross this threshold and make it into Phase 1 human trials,” Chamberland noted in a statement. “Based on the safety data, the medicinal ingredient and the sterile injectable drug product ARDS-003 are both safe for use in humans.”

Chamberland said that the Ottawa-based firm was confident that ARDS-003 will be effective, given 12 years of preclinical efficacy research in sepsis and cytokine hyperinflammatory reactions.

He added: “(This) will allow us to address markets with large unmet medical needs in conditions where uncontrolled inflammatory response contributes to mortality."

Tetra estimates potential revenues from royalties on net sales, milestone and upfront payments of over US$500 million by 2026, based on a conservative market penetration and patient-based model.

Contact Angela at angela@proactiveinvestors.com

Follow her on Twitter @AHarmatas

Quick facts: Tetra Bio-Pharma

Price: 0.155 CAD

TSX:TBP
Market: TSX
Market Cap: $55.56 m
Follow

Add related topics to MyProactive

Create your account: sign up and get ahead on news and events

NO INVESTMENT ADVICE

The Company is a publisher. You understand and agree that no content published on the Site constitutes a recommendation that any particular security, portfolio of securities, transaction, or investment strategy is...

In exchange for publishing services rendered by the Company on behalf of Tetra Bio-Pharma named herein, including the promotion by the Company of Tetra Bio-Pharma in any Content on the Site, the Company receives from...

FOR OUR FULL DISCLAIMER CLICK HERE

Tetra Bio-Pharma expects to bring in $675M in net sales by 2027 from its...

Tetra Bio-Pharma Inc (TSE:TBP) (OTCQB:TBPMF) (FRA:JAM1) SVP of Commercial Strategy Dania Scott tells Proactive the group's CBD-based cancer pain relief drug QIXLEEF, once commercialized, is expected to bring in potential net sales of US$675 million by 2027. Scott says its still premature to...

on 12/07/2020

2 min read