Posted 27 September 2021
Highlights
- DCGI review complete and study formally recommended for regulatory approval
- Multiple clinical sites in India initiated
- Study protocol to recruit 600 participants with COVID-19 overall, with a safety analysis conducted after the first 80 patients
- Study recruitment of DMX-200 in COVID-19 patients hospitalised with respiratory complications will commence in India imminently
- Participant recruitment and dosing expected in next few weeks
- Study subjects will be evaluated for WHO endorsed health score at day 14
- If effective, DMX-200 would likely be COVID-19 strain agnostic based on its mechanism of action
BioMelbourne Network member Dimerix Limited, a clinical-stage drug development company, is pleased to announce that the Indian regulatory agency, the Central Drugs Standard Control Organisation (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.
On 23 August 2021, the National Institute of Disaster Management (NIDM) in India has warned of an imminent third wave of COVID that is expected to peak around October, “…complicated by the new and more virulent mutated variants of SARS Cov-2 that have the ability to escape immunity from earlier infections and in some cases even the prevalent vaccines”. 1 As reported by the BBC in August 2021 , virologist Dr Shahid Jameel commented that “There is also risk in letting people get infected, even while preventing deaths, and that risk is of long-COVID – long-term problems after recovering from the original infection – which afflicts up to a third of those infected, including asymptomatic patients”. 2
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 University of Sydney NHMRC Clinical Trials Centre is extremely pleased with the DCGI recommendation and to be able to commence recruitment in the CLARITY 2.0 study to investigate DMX-200 in patients with COVID-19 imminently. It is possible the virus, particularly the new variants, will be circulating globally for the foreseeable future. It’s essential we continue to investigate new treatments to help reduce the burden of this pandemic.
Vaccines have now been developed that aim to prevent infection or reduce disease severity. However, even with the widespread uptake of vaccines, there will be some who remain susceptible to COVID-19. Improving treatments for patients hospitalised with COVID-19 remains crucial.” Professor Meg Jardine, Director of the NHMRC Clinical Trial Centre, University of Sydney.
As announced on 12 May 2021, the study was submitted to DCGI in quarter 1 2021, however the regulatory process was delayed as a result of the devastating wave of COVID infection affecting India earlier in 2021, and the subsequent impact on the DCGI department reviewing study dossiers. As recruitment begins, the expected timing of study results will become clearer, and any change to the current timelines will be advised.
CLARITY 2.0
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 patients3 (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.
The 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 and The George Institute for Global Health India.
Dimerix recognises and appreciates the support and collaboration of The George Institute for Global Health India within the expanse of research into SARS-CoV-2 and COVID-19. If DMX-200 in combination with an ARB is proven effective for the treatment of COVID-19 and is approved for an indication within this setting, Dimerix is committed to an upscale of opportunity for treatment including a fair and ethical supply of DMX-200 within India in line with industry standards.
“Sadly, the world continues to feel the effects of COVID-19, including here in Australia. We are extremely pleased to be in a position to potentially treat COVID-19 patients suffering debilitating respiratory complications, through both the CLARITY 2.0 study as well as the REMAP-CAP study currently recruiting in Europe.
Whilst COVID-19 is likely to be around for a while yet, if DMX-200 does show benefit in respiratory complications associated with COVID-19, it may also show benefit in respiratory complications associated with other infections too, such as pneumonia and influenza. Thus, this provides an opportunity that could extend well beyond the impact of COVID-19. We look forward to recruiting participants and to reporting on dosing progress in the coming months.” Dr Nina Webster, CEO & Managing Director, Dimerix.
Two Phase 3 Clinical Studies in Respiratory Complications Associated with COVID-19
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.
For further information, please visit www.dimerix.com
