Tetra Bio-Pharma Inc (TSE:TBP) (OTCQB:TBPMF) (FRA:JAM1), a leader in cannabinoid-derived drug discovery, updated investors on Wednesday on the high potential of ARDS-003, its investigational new drug designed to dampen the so-called "cytokine storm" and prevent the development of Acute Respiratory Distress Syndrome (ARDS), the life-threatening condition seen in serious coronavirus (COVID-19) cases.
“Based on a conservative market penetration and patient-based model, Tetra estimates potential revenues from royalties on net sales, milestone and upfront payments of over US$500 million by 2026,” said the Canadian biopharmaceutical company in a statement.
The Ottawa-based company said the patient-based model assumes “low-to-moderate penetration of the COVID-19 market” along with a “small penetration of the sepsis market.” Sepsis is a life-threatening medical emergency where the body has an extreme response to an infection. Tetra Bio-Pharma’s revenue calculation considers a small penetration during ongoing clinical trials of ARDS-003 in sepsis-related indications to expand claims through supplemental marketing approval applications.
The company said ARDS-003 is an optimized sterile nano-emulsion of a synthetic compound that meets pharma standards to be intravenously administered to potentially treat systemic inflammatory response syndrome (SIRS), sepsis, severe sepsis, septic shock, cytokine release syndrome (CRS), acute respiratory distress syndrome (ARDS) and multi-organ disfunction syndrome (MODS).
Tetra Bio-Pharma is planning to submit an application for a Phase I clinical trial to demonstrate safety in healthy volunteers and define the pharmacokinetic profile of ARDS-003, prior to initiating studies in patients with COVID-19.
Tetra Bio-Pharma CEO Guy Chamberland said: "Tetra is dedicated to developing ARDS-003 as a new therapeutic for reducing the severity of the exaggerated inflammatory responses that lead to acute respiratory distress or sepsis. Our focus is both on patient survival and post-survival care.”
“Tetra's science and innovation in exaggerated inflammatory reactions is among the top in the world. Our recent preclinical studies show that this drug will also play a role in post-survival patient care. The potential revenues to Tetra are based on a conservative market penetration of the entire ARDS, sepsis, and COVID-19 markets.”
The Tetra Bio-Pharma boss added that he was “very confident that this drug will play a significant role in addressing the needs of these markets."
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