Fast-track approval for DMX-200 in the UK follows a similar ruling in Europe last week.

As it builds towards Phase 3 clinical trials for the treatment of FSGS kidney disease, Dimerix (ASX:DXB) has received another round of approval from global health regulators.

The company announced this morning that it has received an Innovation Passport for the ILAP (Innovative Licensing and Access Pathway) program from UK regulatory body the MHRA.

The designation is for the company’s DMX-200 drug in the treatment of FSGS (focal segmental glomerulosclerosis), a serious kidney disease.


Global momentum

The decision to reward an ILAP is based on a review of clinical data, and it provides a pathway to accelerate the development of promising medicines.

Commenting on the announcement, Dimerix CEO Nina Webster highlighted the strong traction the company is gaining with global regulatory agencies.

Along with its ILAP designation in the UK, the DMX-200 treatment has been approved as an orphan drug designation in the US and Europe.

Orphan designations are awarded to medicines under development where no other approved treatment options currently exist.

Dimerix’s Phase 3 trial will test the effectiveness of DMX-200 in patients already on the current standard of care for FSGS – a rare kidney disease that affects around 210,000 people globally each year and often leads to kidney failure.

“These designations ultimately accelerate the review of promising therapies targeting unmet medical needs,” Webster said.

“We look forward to working with the MHRA as we progress DMX-200 through the Phase 3 program, and to reporting on the program later this year.”

Only launched in January this year, the ILAP program was designed to promote efficiencies in the approval of treatments, while also meeting the UK’s world-leading standard of care.

Importantly, Dimerix’s entry into the ILAP program means patients will be eligible for early access to the treatment in the event of a successful trial.

The designation also gives DXB the “potential for an accelerated Marketing Authorisation Application (MAA) assessment, a rolling review and a continuous benefit risk assessment”, the company said.

Combined with last week’s approval by the European Medicines Agency (EMA), today’s announcement is more evidence that the DMX-200 treatment is on the radar of global health networks as a potential treatment for a disease where no such solution currently exists.

As it continues to build research momentum, Dimerix has commissioned the NYSE-listed IQVIA Holdings as lead contract research organisation (CRO) in the development of its Phase 3 trial, with more updates expected in the September quarter.

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.