Positive Phase III results for crovalimab in PNH

Roche’s (ROG: SIX) ambition to muscle in on the paroxysmal nocturnal hemoglobinuria (PNH) sector has received another boost, as the Swiss pharma giant today announced positive results from the global Phase III COMMODORE 2 study, evaluating the efficacy and safety of crovalimab in people with PNH who have not been previously treated with complement inhibitors.

The study met its co-primary efficacy endpoints of transfusion avoidance and control of hemolysis (the ongoing destruction of red blood cells measured by lactate dehydrogenase levels). Results showed that crovalimab, a novel, investigational anti-C5 recycling monoclonal antibody, given as a subcutaneous injection every four weeks, achieved disease control and was non-inferior to eculizumab, a current standard of care, which is given intravenously every two weeks.

The ‘standard of care’ product is AstraZeneca’s (LSE: AZN) Soliris (eculizumab), which the UK drugmaker gained rights to through its $39 billion acquisition of Alexion, as well as the latter’s follow-on agent Ultomiris (ravulizumab), giving it a leading position in tackling PHN.