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Tetra Bio-Pharma progressing fast as it advances coronavirus drug candidate ARDS-003 to human trials

Published: 09:25 02 Jul 2021 EDT

Snapshot

Derived from cannabinoids, ARDS-003 is designed to prevent and treat acute respiratory distress syndrome, a severe inflammatory response that could be life-threatening to coronavirus patients

Vial of COVID-19-positive blood on cannabis leaves
  • Biopharmaceutical company with a pipeline of novel proprietary drugs
  • Partnership with medicinal chemistry biotech to ensure new proprietary molecules for long term success
  • Target markets: coronavirus and sepsis, acute and chronic pain, inflammatory diseases of the eye, and cancer
  • Five orphan drug designations from US FDA

What Tetra Bio-Pharma does:

Tetra Bio-Pharma (TSE:TBP) is a Canadian biotechnology company that is reimagining cannabinoid-based drug development.

The Ottawa-based firm has a pipeline of novel proprietary drugs targeted towards a multitude of conditions, but it is their potential coronavirus (COVID-19) treatment that is currently exciting investors.

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 COVID-19 or sepsis.

Tetra is confident that ARDS-003 will be effective, given 12 years of preclinical efficacy research in sepsis and cytokine hyperinflammatory reactions. Potential revenues from royalties on net sales, milestone and upfront payments look to be over US$500 million by 2026, based on a conservative market penetration and patient-based model.

Outside of ARDS-003, the company is advancing a full pipeline of other drug candidates - CAUMZ is targeted towards uncontrolled pain and cancer; PPP-003 is a possible inflammatory eye treatment; HCC-011 is for chemotherapy-induced nausea; and QIXLEEF is being developed as a strong painkiller.

Led by CEO Guy Chamberland, Tetra’s executive team is comprised of drug development veterans and together, the firm has five orphan drug designations from the US Food and Drug Administration (FDA) and patents extending out to 2034.

How is it doing:

Tetra reached a key milestone in early December 2020 after it completed safety trials for ARDS-003. 

In March 2021, the company then revealed that it had received positive feedback from Health Canada on its application for a clinical trial on ARDS-003. Tetra said that Health Canada had acknowledged that the preclinical safety data are “robust and sufficient” to file a clinical trial application designed to treat hospitalized COVID-19 patients, who are at risk of developing ARDS, or acute respiratory distress syndrome.

Tetra said its trial will be the first worldwide drug to involve the use of an injectable sterile synthetic cannabinoid in patients with COVID-19. The company is hoping to demonstrate the effectiveness of ARDS-003 in preventing acute respiratory distress in COVID patients.

Then on June 21, Tetra Bio announced that ARDS-003 studied in a viral-infected organoid model as part of a research collaboration between Targeted Pharmaceuticals and George Mason University had revealed new antiviral properties. It said that a preliminary study on HIV using the HU-308 molecule, the active pharmaceutical ingredient used in ARDS-003, determined that viral replication is significantly decreased when HU-308 is used in combination with a standard antiviral drug to treat HIV. In other words, ARDS-003 clears the virus significantly better than the standard antiviral drug alone.

Away from ARDS-003, in June 2021, Tetra announced that Health Canada had accepted its New Drug Submission (NDS) for REDUVA, the company’s soft gel capsule designed to treat chemotherapy-induced nausea and vomiting (CINV).  The active pharmaceutical ingredient in REDUVO is dronabinol, also known as THC, a synthetic form of the active natural substance in cannabis.

The application entered the final phase of the review process and, If successful, REDUVO will be issued a Notice of Compliance (NOC), as well as a Drug Identification Number (DIN), which permits Tetra to market the drug in Canada.

At the end of May, with regard to QIXLEEF, the company announced that the first patient was recently dosed in the REBORN1 trial of patients with cancer pain. In the REBORN1 study, the screening process requires eligible patients complete a questionnaire for seven continuous days to assess the intensity of their background chronic pain, the number of episodes of breakthrough cancer pain and opioid use.

The company also announced in May that it was speeding up its PLENITUDE clinical trial, a Phase 2 study of QIXLEEF’s safety and effectiveness in managing uncontrolled pain in patients with advanced cancer.

On the financial front, the company revealed in May that it had it generated more than C$47.5 million in revenue from a distribution deal with Danish biopharma DanCann Pharma for the exclusive distribution of Reduvo Adversa, QIXLEEF and ENJOUCA in Denmark, Norway, Sweden, Finland, and Germany.

Tetra also recently undertook financing, raising C$11.5 million in gross proceeds after underwriters exercised an overallotment option in May to a $10 million placing.

Inflection points:

  • ARDS-003 progressing through preclinical trials as a COVID-19 treatment
  • Health Canada review of REDUVA
  • Phase 2 trials of QIXLEEF in 2021, Phase 3 trial in early 2022 

What the boss says:

"Understanding the effect of ARDS-003 on EVs in viral infections is important for guiding the long-term clinical development of Tetra's proprietary asset, particularly since this drug clearly has both anti-inflammatory and antiviral properties,” Tetra Bio-Pharma CEO Dr Guy Chamberland said in June's statement reporting new antiviral properties in its drug candidate ARDS-003

“The neuro-organoid spheres used in this study are like mini brains! They get infected with the virus thereby allowing us to study our drug without infecting live animals. This has transformed how we conduct research," he added.

Contact the author at jon.hopkins@proactiveinvestors.com

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