New trials confirm Dimerix’s DMX-200 is safe in treating COVID-19 patients, results that are both in line with previous studies and consistent with the existing safety profile already known about the company’s flagship drug in other indications. 

In a major development, Dimerix (ASX:DXB) has reported a positive outcome from its CLARITY 2.0 investigator-led study in COVID-19 patients.

The biotech company released top line data from the trial which confirmed that its lead drug, DMX-200, is safe and well-tolerated, with no serious adverse events being reported in patients.

Dimerix says these safety data findings are entirely consistent with the existing safety profile already known about DMX-200.

The study was led by Professor Meg Jardine, Director of the NHMRC Clinical Trials Centre at The University of Sydney,  in collaboration with Professor Vivek Jha, Director of The George Institute, India.

“Although we faced multiple challenges in executing this study, it is pleasing to see the improved outcomes from COVID-19 overall that are associated with high vaccination rates and the uptake of proven therapies,” said Professor Jardine.

Good safety profile

The study enrolled a total of 49 low risk patients, most of whom have been highly vaccinated and with high rates of other COVID-19 treatments.

The median age of the cohort was 37 years, of whom 92% had received prior COVID-19 vaccination.

In addition, 69% of patients received concomitant corticosteroid treatment, a therapy now proven effective in the treatment of hospitalised COVID-19.

During the trial, 25 of those patients received DMX-200, and 24 received a placebo for 28 days. All patients were treated concurrently with an angiotensin receptor blocker (ARB).

At Day 14, 92% of participants did not require hospitalisation and had no limitation on activities (score of 1 on the Health Score Scale) in both arms (Primary Endpoint).

Only 4% in each group had limitations on activities (score of 2 on the Health Score Scale), but were not hospitalised.

“It is extremely pleasing to see, once again, no reason to doubt the safety profile exhibited by DMX-200 in these COVID-19 patients,” says Dr. Nina Webster, CEO of Dimerix.

Dimerix says the use of DMX-200 in this study was based on a clear scientific rationale, being unique and potentially complementary to other drugs being investigated globally.

“The scientific rationale for using DMX-200 in COVID-related respiratory conditions was sound, and whilst it is very pleasing to see that 92% of all patients in the study made a full recovery, we recognise that there were insufficient patient numbers to provide any statistical significance.

“We also recognise that this was the first study of DMX-200 in any respiratory condition, which is a very different cohort of patients compared to kidney disease,” she added.

Given the low-risk patient population recruited, Dimerix decided there was interest in exploring alternative endpoints including time to oxygen-free status, defined as the time to a score of 3 or less.

The median time to oxygen-free status was 4 days in the DMX-200 group, and 5 days in the placebo group.

Meanwhile, the median length of hospital stay was 6 days in the DMX-200 group, and 6 days in the placebo group.

The study was halted early due to recruitment challenges driven in part by falling rates of hospitalised COVID-19.

Dimerix believes that if DMX-200 is shown to be effective in this study, it would also likely be effective against any strain as well as potentially other pneumonias with a common mechanism of action.

DMX-200 is protected by granted patents in various territories until 2032, with patent applications submitted globally that may extend patent protection to 2042.

Dimerix’s strong pipeline

Dimerix has multiple assets in growing markets that have a high unmet need, and no current marketed competition.

Currently, the company has a potential fast pathway to market with its late stage FSGS (Focal segmental glomerulosclerosis) Phase 3 program.

FSGS is a rare disease that attacks the kidney’s filtering units, where blood is cleaned (called the ‘glomeruli’), causing  irreversible scarring.

It’s a billion-dollar plus market, with the number of people with FSGS in the US alone at just over 80,000, and worldwide about 210,000.

The company is also concurrently undergoing diabetic kidney disease and COPD (Chronic obstructive pulmonary disease) programs.

In 2020, Dimerix completed two Phase 2 studies: one in FSGS and one in diabetic kidney disease, following a successful Phase 2a trial in patients with a range of chronic kidney diseases in 2017.

“To date, we have completed four clinical studies in the kidney disease space, all providing consistent and encouraging safety and efficacy data in kidney disease to support our ACTION3 Phase 3 study in FSGS,”explained Dr. Webster.

“Dimerix remains very focussed on its flagship program, the Phase 3 ACTION3 pivotal study of DMX-200 in FSGS.

“We are excited by the progress made and very much look forward to reporting on the upcoming key milestones for this program.”

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.