Dimerix Limited announced that the Indian regulatory agency, the Central Drugs Standard Control Organization (DCGI), met on 02 September 2021 to review the study protocol and has now formally recommended that the DMX-200 clinical study in COVID-19 patients be approved. Multiple clinical sites in India have been initiated and are ready to begin recruitment in the feasibility/Phase 3 clinical study of DMX-200 for the treatment of respiratory complications associated with COVID-19 imminently. The DCGI approval is the final regulatory agency approval required for commencement of recruitment in the CLARITY 2.0 study and the first patient is expected to be dosed in the next few weeks, once, the approval permit is received. Multiple other sites across India are also expected to initiate and commence recruitment in the coming weeks. The company's approach is based on a clear scientific rationale, unique and potentially complementary to others being investigated globally, and importantly if effective in this study, would likely be effective against any strain as well as potentially other pneumonias with a common mechanism of action. The CLARITY 2.0 protocol, as submitted to the DCGI and recommended for approval, is a seamless feasibility/Phase 3, investigator initiated, prospective, multi-centre, randomised, double blind, placebo-controlled study. The DCGI required an amendment to the submitted protocol to include an analysis conducted after the first 80 patients 3 (referred to as a Phase 2 study in the DCGI minutes), before seamlessly continuing to enrol the full 600 patients diagnosed with COVID-19. The primary endpoint will be an 8-point clinical health score measured on treatment day 14. The clinical health score is adapted from the categorical scale recommended by the WHO for COVID-19 trials and ranks health states from being discharged with no limitations through to death. Participants will be treated for up to 28 days with longer term outcomes assessed at 26 weeks. Dimerix lead drug candidate, DMX-200, is being studied as part of two different investigator-led feasibility/Phase 3 studies in COVID-19 patients with respiratory complications. As announced on 03 September 2020, for one of these studies, Dimerix was awarded $1 million from MTPConnect's Biomedical Translation Bridge (BTB) program provided by the Australian Government's Medical Research Future Fund, with support from UniQuest. Dimerix supports both studies driven by the REMAP-CAP and CLARITY 2.0 teams including supply of DMX-200. Dimerix looks forward to reporting on progress and as key milestones are met. Dimerix continues to drive the Phase 3 pivotal study of DMX-200 in FSGS, a rare kidney disorder without an approved pharmacologic treatment that often leads to end-stage kidney failure, following first ethics submission in August 2021, as well as assess the next study design in diabetic kidney disease patients and finally advance the DMX-700 COPD program towards the clinical stage of development.