CLARITY 2.0 Covid-19 study involving Dimerix’s lead drug concludes patient recruitment

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.

Dimerix involved in two key Covid-19 studies

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.

Few treatment options for Covid-19

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.”

Focus on FSGS study and treatments for unmet medical needs

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.