In an exclusive interview, CEO Guy Chamberland tells Proactive why ARDS-003 offers hope in treating the devastating effects of coronavirus and how QIXLEEF could shake up traditional forms of pain relief
Both Bay Street and Wall Street are firmly focused on the biotechnology company’s pipeline of cannabinoid-based drugs, sending Tetra’s share price soaring over 114% since the beginning of February. Last week’s US$7.2 billion mega-merger between Jazz Pharmaceuticals and GW Pharmaceuticals has investors scrambling to add exposure to the exciting new world of cannabinoid therapies, and the Ottawa-based firm is advancing multiple novel treatments through its pipeline.
Two treatments in particular are in the spotlight in 2021. 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, while cancer pain drug QIXLEEF has a "fixed ratio" of THC and CBD and is inhaled through a vaporizer.
Tetra sees huge potential for QIXLEEF in particular, telling shareholders last December that it estimates potential net sales of US$675 million by 2027.
With a clinical trial for QIXLEEF planned to kick off shortly and a Phase 1 study of ARDS-003 anticipated for the first half of 2021, there is a lot of room for excitement for shareholders in this C$104 million company. If that's not enough, the firm is planning to launch itsophthalmic drug program PPE-003 in 2021.
In an exclusive interview, Tetra’s CEO Guy Chamberland told Proactive why ARDS-003 offers hope in treating the devastating effects of COVID-19 and how QIXLEEF could shake up traditional forms of pain relief.
What are your main priorities for the first half of 2021?
Our main priority in the first half of 2021 is to file a Clinical Trial Application and Investigational New Drug Application of Phase 1 and 2A trial in SARS-COV-2 infected patients and complete our studies at the GMU. We also intend to initiate the REBORN1 clinical trial for QIXLEEF very soon. Why are you so confident that ARDS-003 will be effective against COVID-19?
We are confident that ARDS-003 will be effective against COVID-19 and other systemic inflammatory conditions because the active pharmaceutical ingredient in our drug has been evaluated in several animal models of endotoxemia and sepsis. The disease severity in these models was driven by hyperinflammation not dissimilar from that seen in severe COVID-19 patients and sepsis-associated acute lung injury.
Additionally, in vitro studies have illustrated a broad and efficacious anti-inflammatory effect of the medicinal ingredient in ARDS-003. Preclinical studies also demonstrated the protection against multi-organ failure commonly observed in severe COVID patients as well as the ability to prevent pulmonary fibrosis which is now a recognized cause of morbidity in COVID-19 survivors. Across all models, our API has been shown to decrease high levels of inflammatory cytokines which are elevated in severe COVID-19.
When can we expect the treatment to be made widely available?
If a phase 2A were to be successful, the drug would be made available through the emergency use authorization procedures.
How are you planning to bring QIXLEEF to market and are you on track to meet that 2023 timeline?
It is our goal to bring QIXLEEF to market as a pharmaceutical product by completing the PLENITUDE and REBORN1 clinical trials and ensuring that all other regulatory requirements of the FDA are addressed. We are still on track with meeting our established timelines.
For layman investors, what is the science behind inhalation? Why is it important?
Inhalation delivers a fast onset of action compared to oral absorption providing patients with relief from pain much more rapidly. This is important because patients suffering from breakthrough pain need relief quickly. Fast relief from pain may also lead to improved quality of life for many patients.
What’s next in the pipeline?
Our top priority is moving ARDS-003 into human trials as soon as possible. We intend to prepare for a second indication in sepsis. With PPP-003, we intend to be ready to initiate trials in patients with eye diseases such as uveitis or PVR (proliferative vitreoretinopathy).