Veru Inc., reaches agreement with FDA on a new phase III clinical trial for sabizabulin for broader indication: hospitalized adult patients with any type of viral acute respiratory distress syndrome (ARDS).

The Phase III study may suffice as a single study for NDA submission.

Highlights from the September 21st FDA meeting: FDA agreed to a Phase III, randomized (1:1), multicenter, placebo-controlled, parallel group design study to evaluate the efficacy and safety of sabizabulin 9mg oral daily dose plus standard of care treatment versus placebo plus standard of care treatment in hospitalized adult patients with any type of virus inducing ARDS: i.Novel indication (patient population) for sabizabulin has been expanded to include all hospitalized adult patients with any type of viral induced ARDS. ii. Endpoints: a. Primary efficacy endpoint is all-cause mortality at day 60. b. Secondary endpoints include days in the hospital, days in the ICU, days on mechanical ventilation, and proportion of patients alive without respiratory failure. iii. Given the high mortality rate for viral induced ARDS (27-45%), the expected size of the study is 408 patients. iv. If Phase III study were to demonstrate sufficient benefit on all-cause mortality at Day 60, then this study could potentially be sufficient for NDA submission.

As the program has FDA Fast Track designation, a rolling NDA submission is a possibility for sabizabulin .

"As sabizabulin has broad host directed antiviral and anti-inflammatory activities and an already completed, positive well controlled and adequate Phase III COVID-19 clinical study in patients at risk for or had ARDS, we felt compelled to reengage with FDA to consider the possibility of expanding the patient population to include hospitalized adult patients that have any type of viral induced ARDS, especially in light of the CDC expecting a high rate of tripledemic virus hospitalizations this fall and winter,” said Mitchell Steiner, M.D., Chairman, President and Chief Executive Officer of Veru. “We are pleased with the outcome of our meeting with FDA in which they agreed to a Phase III study design that allows the treatment of sabizabulin to be evaluated on top of standard of care in a broader hospitalized viral induced ARDS patient population. FDA agrees that ARDS is a well-defined disease with a high mortality rate in which there is a compelling unmet medical need.”