The company also added some important updates post quarter-end for its leading Phase 3 FSGS study.

Clinical stage biotech Dimerix (ASX:DXB) confirmed another round of strong progress in its globally recognised development pathway, with the release of its quarterly trading update this morning.

During the quarter, Dimerix flagged key advancements across its three core trials, along with some exciting post-quarter updates.

The group’s near-term development strategy is highlighted by its Phase 3 study on the efficacy and safety of its proprietary DMX-200 drug formula in the treatment of FSGS (Focal Segmental Glomerulosclerosis) – a rare kidney disease.

Today’s update also confirmed that Dimerix continues to find strong research momentum in two separate global studies – CLARITY 2.0 and REMAP-CAP — incorporating the use of DMX-200 in treatment solutions for COVID-19 patients with respiratory complications.

 

FSGS Phase 3 study – ACTION3

Around 210,000 people worldwide suffer from FSGS each year, with 80,000 of those in the US alone.

With no existing treatment, FSGS is a billion-dollar-plus market for medical companies that can formulate innovative treatment solutions.

DXB’s Phase 3 study is called Angiotensin II Type 1 Receptor (AT1R) & Chemokine Receptor 2 (CCR2) Targets for Inflammatory Nephrosis” – or ACTION3 for short.

The major study will engage in recruitment across 12 different countries globally.

“During the quarter, 11 of the 12 countries received ethics and/or regulatory approval to conduct the study in preparation for patient recruitment,” Dimerix said.

Recruitment for the study is now underway in approved jurisdictions, where Dimerix has appointed IQVIA as its lead Contract Research Organisation (CRO) to help manage the recruitment process.

Notably, IQVIA is the world’s largest CRO and has specific industry experience building trials for late-stage FSGS treatments.

The trial is a “randomised, double-blind, placebo-controlled study of the efficacy and safety of DMX-200”, for FSGS patients who are already receiving a stable dose of an angiotensin II receptor blocker (ARB), Dimerix said.

Once the ARB dose is stable, patients aged 18 to 80 will receive either DMX-200 through two daily doses of a 120mg capsule, or a placebo.

Investors can then look forward to the first set of interim analysis results which are expected in the first half of 2023.

As the global trial progresses, Dimerix also flagged an important post-quarter announcement, with its submission of a new global patent application titled ‘Treatment of Inflammatory Diseases’.

If granted, the patent application will “extend and broaden the protection for DMX-200 until at least March 2041”, Dimerix said – beyond the current time frame of 2032.

 

COVID-19 studies

REMAP-CAP

Operated by a consortium of expert trialists and clinicians, the ACE2 RAS study is a globally coordinated study backed by a sponsor, REMAP-CAP, for a novel combination therapy for patients hospitalised with moderate to severe COVID-19 pneumonia.

Patients in the study are randomised to receive one of three different RAS blockade treatment arms, including the DMX-200 arm, or a control.

During the quarter, assessment work by the Independent Data Safety Monitoring Board (DSMB) flagged some concerning safety signals in critically ill patients in the study arms where patients were receiving an ACE inhibitor or an angiotensin receptor blocker (ARB).

Importantly, “no concerns were communicated with regards to DMX-200”, Dimerix said.

Recruitment of patients in study has been paused pending full analysis by REMAP-CAP, and the results will be released as soon as data is available.

During the quarter, Dimerix also confirmed it’s now received the full $1m amount in connection with its successful 2020 funding application under the Australian Government’s Medical Research Future Fund.

Late last year, the company also received a further $100,000 “to support commercialisation activities for Dimerix lead candidate, DMX-200, in patients with COVID-19”.

 

CLARITY 2.0

Also during the quarter, Dimerix advanced the separate CLARITY 2.0 study which is open for recruitment across Australia and India.

CLARITY 2.0 is a “multi-centre, randomised, double blind, placebo-controlled study, which aims to enrol 600 patients diagnosed with COVID-19”, DXB said.

With recruitment now open in India, the first patients were dosed in January 2022. Multiple dosing sites have now been approved in accordance with guidelines set out by India’s regulatory agency, the Central Drugs Standard Control Organization (DCGI).

With initial recruitment slightly slower than anticipated, Dimerix and the joint investigators now expect recruitment for the first cohort of 80 patients to be completed in the June quarter.

An interim safety analysis will then be conducted before the program expands to Australia, where it received ethics approval in December last year.

With multiple assets in its investment pipeline, investors still have lots of exciting updates to look forward to in the short-to-medium term.

Its core product suite operates in “commercially attractive and growing markets that have a high unmet need, no current marketed competition, and with a potential fast pathway to market”, the company said.

In that context, the dynamic ASX biotech “looks forward to reporting on progress and as key milestones are met”.

 

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.

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