Dimerix gains on China drug application approval
Health & Biotech
Health & Biotech
Special Report: Dimerix was up 14% in morning trade after Chinese authorities approved an investigational new drug (IND) application to commence recruitment for its ACTION3 Phase 3 study of DMX-200, for focal segmental glomerulosclerosis (FSGS) kidney disease.
Biopharmaceutical company with late-stage clinical assets Dimerix (ASX:DXB) has announced the Chinese National Medical Products Administration (NMPA) Centre for Drug Evaluation (CDE) has approved an IND so it can start recruiting for the pivotal trial.
DXB is currently recruiting across 70 clinical sites in 11 countries for its Phase 3 trial titled Angiotensin II Type 1 Receptor (AT1R) & Chemokine Receptor 2 (CCR2) Targets for Inflammatory Nephrosis, or ACTION3 for short.
The full study will enrol 286 patients with FSGS globally, including some in mainland China.
The pivotal multi-centre, randomised, double-blind, placebo-controlled study will evaluate efficacy and safety of DMX-200 in patients with FSGS who are receiving a stable dose of an angiotensin II receptor blocker (ARB).
Once the ARB dose is stable, patients will be randomised to receive either DMX-200 (120mg capsule twice daily) or placebo.
DXB intends on opening sites in additional countries, including China, following release of Part 1 analysis expected on or around March 15, 2024.
ACTION3, which has two interim analysis points built into the trial, is designed to capture evidence of proteinuria and kidney function (eGFR slope), to generate sufficient support for marketing approval.
A subset of 144 patients (Part 2) enrolled in the study from all countries, including Mainland China, is to be incorporated in an interim analysis towards accelerated/conditional marketing approval in regions where early access to medicines is possible.
DXB says importantly, the IND approval confirms that no further manufacturing, non-clinical or clinical (bridging) studies are required before recruitment of Chinese patients in ACTION3–which are often required for other product candidates as a prerequisite.
DXB says the open IND will likely further support partnering discussions in the region.
FSGS is a rare condition affecting the kidney’s filtering units, where blood is purified, resulting in permanent kidney damage and eventual organ failure, necessitating either dialysis or a transplant.
There are currently no approved therapies for the condition with a high unmet need, making it a substantial market opportunity estimated at billions of dollars for DXB.
DXB says the total FSGS market in China alone is valued at US$2.2 billion by 2027, driven by more than 100,000 patients in mainland China with FSGS.
DXB has already secured orphan drug designation (ODD) for DMX-200 in both the US and Europe for the treatment of FSGS due to the absence of an effective therapy.
The brand name QYTOVRA has been approved for DMX-200 by the United States Food and Drug Administration (FDA), and may be used as the brand name in some regions.
DXB says positive data from the ACTION3 study may support a future marketing authorisation application for DMX-200 in China.
DXB announced in October an exclusive license agreement with multinational pharmaceutical company Advanz Pharma.
The deal covers the European Economic Area, UK, Switzerland, Canada, Australia, and New Zealand for commercialisation of DMX-200 for the treatment of FSGS following regulatory approval.
DXB chief medical officer Dr David Fuller says the NMPA approval is a milestone event that allows the ACTION3 study to commence enrolment in the world’s second largest pharmaceutical market and provide a new clinical trial option for FSGS patients in China.
“We are delighted that no bridging study in a Chinese population is required, which would allow the study to commence in China more efficiently after first analysis outcome,” he says.
“We look forward to reporting the outcome of the study’s first analysis in March 2024.”
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.