Huge news!!!
Tetra Bio-Pharma progressing fast as it advances coronavirus drug candidate ARDS-003 to human trials
Vial of COVID-19-positive blood on cannabis leaves
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
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.
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:
"The severity of Sars-CoV-2 infection in a patient has significant impacts on our health care system,” Tetra CEO Guy Chamberland said in May.
“ARDS-003 can become a valuable therapeutic if clinical trials demonstrate a reduction in the severity of the infection. Tetra is also studying the benefits of ARDS-003 on the immune system response to establish advantages over the use of dexamethasone in Acute Respiratory Distress Syndrome or Sepsis patients. We believe a broad action immunomodulator that does not result in pronounced immune suppression will play a more significant role."
Contact Andrew Kessel at andrew.kessel@proactiveinvestors.com
Follow him on Twitter @andrew_kessel
