CLARITY 2.0 Covid-19 study involving Dimerix’s lead drug concludes patient recruitment
Health & Biotech
Health & Biotech
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Dimerix has announced a second key study for the treatment of Covid-19 has concluded recruitment.
Aussie clinical stage biotech Dimerix (ASX:DXB) has announced the CLARITY 2.0 led study of Covid-19 patients has concluded recruitment, enabling it to be analysed and reported.
Dimerix said an interim safety analysis was planned after the first 80 patients were recruited in India.
However, given additional patient recruitment would unlikely change the data outcomes relating to safety and efficacy, recruitment was closed at 49 to enable faster reporting of results.
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 its lead drug DMX-200 to the study sites.
The CLARITY team will analyse the results with Dimerix and report the outcome as soon as it has been received.
If found to be effective, DMX-200 may be beneficial for patients with a wide range of respiratory diseases in addition to the various Covid-19 variants.
Dimerix has been involved in two key studies for the treatment of Covid-19 using DMX-200.
In June the company announced REMAP-CAP had closed recruitment of moderate state (non-critically ill) Covid-19 patients to the ACE2 RAS Domain clinical study, which involved DMX-200. Recruitment of critically ill patients to the trial was closed in February.
Dimerix CEO and managing director Dr Nina Webster said there remains few treatment options for Covid-19.
“The CLARITY and REMAP-CAP studies were important to support 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,” she said.
“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.”
Dimerix is focused on providing treatments for unmet medical needs, including its flagship program the Phase 3 ACTION3 pivotal study of DMX-200 in rare kidney disease focal segmental glomerulosclerosis (FSGS).
FSGS has no existing registered treatment option and cost the US healthcare system US$55 billion per annum in 2021.
It is also working towards advancing its diabetic kidney disease program towards the next clinical study.
In June Dimerix announced it had entered into an agreement with The Australian Centre for Accelerating Diabetes Innovations (ACADI).
The key agreement will progress its lead drug asset DMX-200 into a new clinical trial in patients with diabetic kidney disease.
DMX-700 was identified as a potential treatment of chronic obstructive pulmonary disease (COPD), with a recent study delivering promising initial results in mice.
Dimerix is now planning the first clinical study for the DMX-700.
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.