- The Indian regulatory agency recommends Dimerix’s (DXB) DMX-200 clinical study in COVID-19 patients be approved
- This approval is the final regulatory agency approval required to begin the CLARITY 2.0 study
- Once the approval permit has been received, the first patient is expected to be dosed in the next few weeks
- The CLARITY 2.0 study will be randomised and placebo-controlled, with the primary desired endpoint an eight-point clinical health score on day 14
- Dimerix was up 8.93 per cent on the market with shares trading at 30.5 cents at 12:23 pm AEST
The Indian regulatory agency has recommended that Dimerix’s (DXB) DMX-200 clinical study in COVID-19 patients be approved.
On September 2, the Central Drugs Standard Control Organisation (DCGI) met to review the study protocol and this approval is the final regulatory agency approval required to begin the CLARITY 2.0 study.
Multiple clinical sites have been prepared and are ready to begin recruitment in the phase 3 study of DMX-200 in the treatment of respiratory complications associated with COVID-19.
Once the approval permit has been received, the first patient is expected to be dosed in the next few weeks.
Multiple other sites across India are expected to begin recruitment in the coming weeks.
The CLARITY 2.0 study will be randomised, double blind, placebo-controlled, multi-centre and prospective.
The primary endpoint will be an eight-point clinical health score measured on treatment day 14.
Participants will be treated for up to 28 days with longer-term outcomes assessed at 26 weeks.
The study will be led by Professor Meg Jardine from the NHMRC Clinical Trials Centre at the University of Sydney, Professor Vivek Jha and the George Institute for Global Health India.
CEO and Managing Director Dr Nina Webster has commented on the trial.
“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,” Dr Webster said.
“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.”
Dimerix was up 8.93 per cent on the market with shares trading at 30.5 cents at 12:23 pm AEST.