Biopharmaceutical company Dimerix Limited (ASX: DXB) has confirmed that the first patients have been dosed in India in the CLARITY 2.0 feasibility/Phase 3 study of DMX-200 as a potential new treatment for respiratory complications associated with COVID-19.
Multiple sites had been initiated in India following regulatory approval from the Indian regulatory agency, the Central Drugs Standard Control Organization (DCGI), and shipment of DMX-200 drug supply to India from Dimerix’ US based manufacturer.
An interim safety analysis is planned after the first 80 patients recruited in India in the 600-patient study, which expected to occur in the first quarter of 2022.
The study also plans to recruit COVID-19 patients in Australia, for which ethics approval was received in December 2021.
Any new treatment for COVID-19 respiratory complications will be very much welcomed by patients, their families and the medical community,” said Professor Vivekanand Jha, Principal Investigator and Executive Director, George Institute India.
“Inflammatory disease treatments such as DMX-200 hold significant potential to improve clinical response, survival and quality of life post treatment, and we are looking forward to investigating this drug in patients.”
CLARITY 2.0 study
Europe has reported a weekly incidence rate increase of 65% where Dimerix is also recruiting patients in a second REMAP-CAP COVID-19 feasibility/Phase 3 clinical study.
According to the WHO, the death rate has sadly increased 22% in the past week in the African Region where Omicron was first reported.
The company’s approach is based on a clear scientific rationale, is unique and potentially complementary to others being investigated globally, and importantly if effective in this study, would likely be effective against any strain as well as potentially other pneumonias with a common mechanism of action.
Antiviral medications are typically effective at preventing damage caused by a virus when administered within three to five days of infection (when many are asymptomatic), as the treatment aims to minimise viral replication.
In contrast, DMX-200 does not rely on early inhibition of viral replication but aims to prevent the damaging immune response and lung flooding regardless of vaccination or antiviral treatment.
As such, DMX-200 may be beneficial for patients with a wide range of respiratory diseases in addition to the various COVID-19 variants.
The CLARITY 2.0 protocol is a seamless feasibility/Phase 3, investigator initiated, prospective, multicentre, randomised, double blind, placebo-controlled study.
The study protocol includes an interim safety analysis after the first 80 patients in India, before seamlessly continuing to enrol the full 600 patients diagnosed with COVID-19.
The primary endpoint will be an 8-point clinical health score measured on treatment day 14. The clinical health score is adapted from the categorical scale recommended by the WHO for COVID-19 trials and ranks health states from being discharged with no limitations through to death. Participants will be treated for up to 28 days with long-term outcomes of treatment assessed at 26 weeks. The study in both Australia and India is led by Professor Meg Jardine, Director of the NHMRC Clinical Trials Centre at The University of Sydney, Australia, in collaboration with Professor Vivek, Jha, Director of The George Institute, India.
Phase 3 Clinical Studies in Respiratory Complications Associated with COVID-19 Dimerix lead drug candidate, DMX-200, is being studied as part of two different investigator-led feasibility/Phase 3 studies in COVID-19 patients with respiratory complications, both of which are actively recruiting.
For one of these studies Dimerix was awarded $1.1 million from MTPConnect’s Biomedical Translation Bridge (BTB) programme provided by the Australian Government’s Medical Research Future Fund, with support from UniQuest.
Dimerix proactively supports both studies driven by the REMAP-CAP and CLARITY 2.0 teams in providing them information for the regulatory submissions and in supplying DMX-200 to the study sites. Dimerix looks forward to reporting on progress and as key milestones are met.
Dimerix continues to progress the Phase 3 pivotal program in FSGS, a rare kidney disorder without an approved pharmacologic treatment that often leads to end-stage kidney failure, as well as assess the next study design in diabetic kidney disease patients and finally advance the COPD program towards the clinical stage of development.