Edesa Biotech has shared data from its truncated phase 3 respiratory failure trial, linking the anti-TLR4 antibody to improvements in survival and recovery.
The trial enrolled about 100 people who were hospitalized and on invasive mechanical ventilation before Edesa suspended the study on business grounds. Participants received single infusions of Edesa’s paridiprubart, also called EB05, or placebo to treat acute respiratory distress syndrome (ARDS) caused by COVID-19.
After 28 days, the risk of death in the paridiprubart arm was 39% versus 52% in the placebo cohort. The 60-day risk of death was 46% on paridiprubart and 59% on placebo, which the biotech claimed as a primary endpoint win. Edesa also linked its drug candidate to improvements on a COVID-19 severity scale.
The difference in 28-day mortality was smaller than in Edesa’s phase 2 trial. In the earlier, smaller study, the biotech reported (PDF) 28-day death rates of 7.7% for paridiprubart and 40% for placebo.
The latest data come from a trial Edesa began before rethinking its plans in light of U.S. government support for paridiprubart. The Biomedical Advanced Research and Development Authority (BARDA) selected the drug candidate for inclusion in a platform trial of potential ARDS treatments last year. Edesa stopped enrollment in its phase 3 trial shortly after the news.
Given the scope of the BARDA study, the biotech decided to shift its focus to general ARDS rather than cases caused by COVID-19. Edesa is now awaiting the results of the BARDA trial to inform the design of a phase 3 study supported by the Canadian government.
Edesa has listed 2027 as the due date for data from the BARDA trial, citing a ClinicalTrials.gov entry with a primary completion date of November 2027. The biotech had $12.4 million to its name at the end of June, leading it to flag a substantial doubt about its ability to continue as a going concern.