First site open for Dimerix kidney disease trial in Japan, triggers milestone payment

The first site in Japan opens for Dimerix’s ACTION3 Phase 3 clinical trial of DMX-200 in rare kidney disease focal segmental glomerulosclerosis.

It’s action in Japan with the first site opening for Dimerix’s ACTION3 phase III trial. Pic via Getty Images.

• First site in Japan opens for Dimerix’s ACTION3 phase III clinical trial of DMX-200 in rare kidney disease

• Opening of trial site triggers first development milestone payment of ¥400 million (~A$4.3m) to Dimerix

• Further sites forecast to open to recruit patients and support potential approval of DMX-200 in Japan

 

Special Report: Dimerix has opened the first trial site in Japan for its ACTION3 phase III drug candidate DMX-200 to treat focal segmental glomerulosclerosis (FSGS) kidney disease.

Opening of Japan’s first clinical trial site for ACTION3 triggers the first development milestone payment of ¥400 million (~A$4.3m) to Dimerix (ASX:DXB) from FUSO Pharmaceutical Industries Ltd, its exclusive licensee of DMX-200 for FSGS in Japan.

Dimerix said like other territories, the clinical trial approval process was sequential in Japan and importantly opening of the first clinical trial site was the final step required before recruiting patients in the country.

Opening of the first site follows prior approval by the Japanese Pharmaceutical and Medical Device Agency (PMDA), ethics committee approval and finalisation of clinical trial agreements with participating sites.

Other Japanese trial sites are set to follow to support recruitment of ACTION3, with ~20 patients to be recruited to support potential approval of DMX-200 for FSGS in Japan.

Lucrative Japanese licensing deal

Dimerix announced in January it had inked an exclusive development and licensing agreement for development and commercialisation of DMX-200 to treat FSGS in Japan and received an upfront payment of ¥300 million (~A$3.2 million) in March.

Under the deal FUSO will be responsible for clinical development costs in Japan, submission and maintenance of the regulatory dossier with the Japanese regulatory agency PMDA, as well as all sales and marketing activities in the country.

Dimerix will continue to fund and execute the global ACTION3 Phase 3 study for DMX-200 in FSGS patients outside Japan.

The company expects to receive the first development milestone payment within 30 days from FUSO.

Under the deal Dimerix will receive potential development and commercialisation milestones of up to ¥9.8 billion (~A$100m).

In addition, Dimerix is eligible to receive royalties of between 15-20% on net sales of DMX-200 if successfully commercialised.

“Opening the first clinical site in Japan is another major step forward for our global ACTION3 clinical program as we aim to bring much needed and new treatments to patients with FSGS around the world,” CEO and managing director Dr Nina Webster said.

“This milestone reflects the strength of our data to date, the rigor of our clinical trial design and the expertise from our local partner in Japan, FUSO.”

Four regional licensing deals worth up to $1.4bn

FUSO is one of four regional licensing deals executed for DMX-200. Dimerix said collectively these deals provided up to ~$1.4bn in total upfront payments and potential milestone payments, plus royalties on net sales.

At the start of May Dimerix announced an exclusive licensing agreement with Nasdaq-listed Amicus Therapeutics to commercialise DMX-200 for FSGS in the US.

Amicus has exclusive rights to develop DMX-200 in other future indications in the world’s largest healthcare market.

In October 2023, Dimerix inked a licensing deal with Advanz Pharma covering the European Economic Area, UK, Switzerland, Canada, Australia and New Zealand for commercialisation of DMX-200 for the treatment of FSGS following regulatory approval.

In May 2024, Dimerix announced a licensing agreement with Taiba for FSGS covering multiple Middle Eastern countries, including the UAE, Saudi Arabia, Oman, Kuwait, Qatar, Bahrain and Iraq.

Dimerix retains full commercialisation rights for DMX-200 in all regions not covered by the Amicus, Fuso, Advanz Pharma and Taiba agreements.

The company said it continued to focus on ACTION3 phase III  clinical trial delivery and   licensing opportunities with potential partners in territories not already licensed.

Much-needed treatment for rare disease

FSGS is a serious kidney disease that causes progressive scarring, leading to permanent damage and, ultimately, end-stage kidney failure — often requiring dialysis or a transplant.

It affects adults and children with no treatments are currently approved specifically for this condition anywhere in the world, affecting overall prognosis.

As a result, DMX-200 has received orphan drug designation in both the US and Europe, along with the UK’s equivalent designation under the Innovative Licensing and Access Pathway (ILAP).

DMX-200 is a small molecule inhibitor of the chemokine receptor 2 (CCR2). The ACTION3 trial is a randomised, double-blind, placebo-controlled study of the efficacy and safety of

DMX-200 in patients with FSGS who are receiving a stable dose of an angiotensin II receptor blocker (ARB).

It is designed to capture evidence of proteinuria and kidney function (eGFR slope) during the trial, aimed at generating sufficient evidence to support marketing approval.

In early 2024 Dimerix reported positive interim results from the ACTION3 trial showing DMX-200 was performing better than placebo in reducing proteinuria with no safety concerns to date.

Full enrolment in the ACTION3 study is expected by the end of 2025 with a further blinded interim analysis planned.

This article was developed in collaboration with Dimerix,  a Stockhead advertiser at the time of publishing.

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