Clinical-stage drug development company Dimerix (ASX:DXB) has announced that the Indian regulator, the Central Drugs Standard Control Organization (DCGI), has formally recommended the approval of the study of DMX-200 in patients with COVID-19.
The company said multiple sites in India have been initiated and are ready to begin recruitment in the feasibility/Phase 3 study of DMX-200 for the treatment of respiratory complications associated with COVID-19 imminently.
DCGI approval is the final regulatory agency approval required for the commencement of recruitment in the CLARITY 2.0 study. The first patient is expected to be dosed in the next few weeks once the approval permit is received.
The company said multiple other sites across India are expected to initiate and commence recruitment in the coming weeks.
“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," said Professor Meg Jardine, the director of the NHMRC Clinical Trial Centre at the University of Sydney.
"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.”
The study was submitted to DCGI in the first quarter of 2021. However, the regulatory process was delayed due to the impact of the third wave of COVID-19 infection.
“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,' said Dr Nina Webster, CEO and managing director of Dimerix.
"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.”