Final clinical trial approval is expected by April for the study, in which Dimerix’s DMX-200 treatment plays a key role as part of a combined COVID-19 treatment.
Dimerix (ASX:DXB) has advised that the international CLARITY 2.0 study for a combined treatment in the fight against COVID-19 has received a new round of approvals from health regulators in India.
DXB’s patented DMX-200 drug is included as part of the program, which targets COVID-19 patients experiencing early-stage respiratory difficulties.
And the company announced this morning that the study has received key approval from India’s Central Independent Ethical Review Board as it moves towards clinical trials.
Review board approval is a prerequisite for the study to receive final approval from the Indian regulatory authority.
Investors responded to the news, sending shares in Dimerix more than six per cent higher in morning trade to 26c.
CLARITY 2.0
A joint collaboration between the University of Sydney and The George Institute for Global Health India, the CLARITY 2.0 program is one of two studies incorporating DMX-200 as part of a treatment combination for COVID-19.
The collaborative effort is being led by Professor Meg Jardine from the NHMRC Clinical Trials Centre at The University of Sydney.
The other study is called REMAP-CAP, which targets patients suffering from the onset of Acute Respiratory Distress Syndrome (ARDS).
While COVID-19 vaccine rollouts have commenced, other clinical treatment options will still play a crucial role in negating the disease – particularly for companies with large populations such as India.
With approval from India Ethical Review Board, the CLARITY 2.0 team is now assessing a number of clinical trial sites.
Patient recruitment will commence once final approval is obtained, which is expected to occur in April.
Demonstrating the scope of the study, the CLARITY 2.0 team is putting together a Phase 3 study comprising 600 patients.
The study is targeting a seven-point clinical health reading at Day 14 of treatment, in line with the Ordinal Scale for clinical trial outcomes recommended by the World Health Organisation for COVID-19 trials.
DXB’s DMX-200 drug is an important part of both the CLARITY 2.0 study and the RECAP-MAP study.
As an endorsement of that fact, the company was awarded a $1m grant from the Australian government’s Medical Research Future Fund in connection with the REMAP-CAP study.
The award was based on strong scientific rationale for the use of DMX-200 in a combined treatment setting for COVID-19.
The news marks another exciting step forward for Dimerix as it prepares for advanced stage trials across multiple use-cases for its DMX-200 kidney treatment.
Speaking with Stockhead recently, CEO Nina Webster detailed the company’s near-term focus on the treatment of FSGS (focal segmental glomerulosclerosis) – a rare kidney disease.
The company has approval from US health regulators to carry out a single Phase 3 trial for its FSGS treatment, with the program to be initiated by the middle of this year.
This article was developed in collaboration with Dimerix, a Stockhead advertiser at the time of publishing.
This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.