Dimerix (ASX: DXB) says the CLARITY 2.0 investigator-led study of COVID-19 patients has concluded recruitment.
The company said an interim safety analysis was planned after the first 80 patients were recruited in India.
"Given additional patient recruitment would likely not change the data outcomes relating to safety and efficacy, recruitment was closed prior to the 80 patients which will enable the faster reporting of results. In total, 49 patients were recruited into the study," it said.
The study is an investigator-led trial. Dimerix said it proactively supported the study driven by the CLARITY 2.0 team by providing them with information for the regulatory submissions and supplying DMX-200.
Dimerix said it remains focussed on its flagship program. This is the Phase 3 ACTION3 pivotal study of DMX-200 in Focal Segmental Glomerulosclerosis (FSGS), advancing the diabetic kidney disease program towards the next clinical study, and planning the first clinical study for the DMX-700 chronic obstructive pulmonary disease program.
“Dimerix was pleased to support both the CLARITY and REMAP-CAP studies into the treatment of COVID-19 disease using DMX-200 based on its compelling mechanism of action and demonstrated safety profile, particularly as there were few viable therapeutic options for treatment of COVID," said CEO and managing director Dr Nina Webster.
"With the recruitment now concluded, the current data can be assessed for positive signs of proof of concept. If a positive signal is substantiated, Dimerix may then assess the next steps to progress towards the ultimate therapeutic outcome for these patients. With both COVID studies now under data review by the investigators, Dimerix' continues to focus on our lead Phase 3 FSGS program, and further pipeline development.”