Posted: 18 August 2022
Dimerix Limited (ASX: DXB) a biopharmaceutical company with Phase 3 clinical studies in inflammatory diseases currently underway, today confirmed that the CLARITY 2.0 led study of COVID-19 patients has concluded recruitment to allow this study to be analysed and reported. An interim safety analysis was planned after the first 80 patients 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.
Highlights
- CLARITY 2.0 investigator-led study in COVID-19 patients concludes recruitment
- 49 patients were recruited into the CLARITY 2.0 study
- Safety and efficacy results of the clinical trial currently being analysed by CLARITY team and will be reported as soon as available
- If effective, DMX-200 may be beneficial for patients with a wide range of respiratory diseases in addition to the various COVID-19 variants1
- Dimerix remains focussed on its flagship program, the Phase 3 ACTION3 pivotal study of DMX-200 in Focal Segmental Glomerulosclerosis (FSGS) which is actively recruiting globally2
As an investigator-led trial, the study has been a relatively low-cost source of potential clinical data for Dimerix. Dimerix proactively supported the study driven by the CLARITY 2.0 team in providing them information for the regulatory submissions and in supplying DMX-200 to the study sites.
The results of this study will be analysed by the CLARITY team. Dimerix will report the outcome as soon as it has been received from CLARITY.
Dimerix remains focussed on its flagship program, 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 (COPD) 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. 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.” Dr Nina Webster, Dimerix CEO & Managing Director.
CLARITY 2.0 Rationale
The use of DMX-200 in this study was based on a clear scientific rationale, being 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.1
Antiviral medications are typically effective at preventing damage caused by a virus when administered within 3-5 days of infection (when many are asymptomatic), as the treatment aims to minimise viral replication.3 In contrast, DMX-200 does not rely on early inhibition of viral replication but aims to prevent the damaging immune response and lung flooding regardless of vaccination or antiviral treatment. As such, DMX-200 may be beneficial for patients with a wide range of respiratory diseases in addition to the various COVID-19 variants.1
The CLARITY study is led by Professor Meg Jardine, Director of the NHMRC Clinical Trials Centre at The University of Sydney, Australia, in collaboration with Professor Vivek, Jha, Director of The George Institute, India.
For further information, please visit our website at www.dimerix.com or contact:
Dr Nina Webster
Dimerix Limited
Chief Executive Officer & Managing Director
Tel: +61 1300 813 321
E: investor@dimerix.com
Rudi Michelson
Monsoon Communications
Tel: +61 3 9620 3333
Mob: +61 (0)411 402 737
E: rudim@monsoon.com.au
