Dimerix collects data from 72 patients taking part in the Phase 3 trial of DMX-200 for the kidney disease FSGS
First interim analysis outcome remains on track to be released on or before 15 March 2024
This will determine if DMX-200 performs better than the placebo in reducing an important biomarker of FSGS progression
Special Report: Dimerix is on track to release interim analysis outcome from its Phase 3 trial of DMX-200 in patients with focal segmental glomerulosclerosis (FSGS) in March 2024 after collecting data from all 72 patients.
This coming milestone, which takes DXB-200 a key step towards potential market approval, follows 12 years of work since the drug was first identified for use in the kidney disease.
FSGS results in scarring of kidney filtering units over time (about five years) until there are not enough kidney cells left to effectively filter blood.
Dimerix (ASX:DXB) are currently the global leaders in this area, as there are no products approved for the rare illness and the current prognosis for FSGS patients is poor.
Highlighting this potential, the company finalised in 2023 an exclusive licensing agreement worth up to $230m for Europe, Canada and Australia/New Zealand with multinational pharmaceutical company Advanz Pharma that includes tiered, escalating, mid-teen to twenty percentage royalties on net sales of DMX-200 if it is successfully commercialised.
The ACTION 3 Phase 3 study, which seeks to eventually enrol 286 patients globally, is designed to capture evidence of proteinuria and kidney function to generate sufficient support for marketing approval.
Plans also include enrolling patients in China, which represents a significant market, after Chinese authorities approved an investigational new drug (IND) application in late November 2023.
Interim analysis remains on track
DXB has now successfully collected data from the first 72 patients randomised in the ACTION3 Phase 3 trial.
This will feed into the first interim efficacy and safety analysis and review by the Independent Data Safety Monitoring Committee (IDMC), which is expected to be released on or before 15 March 2024.
In line with best practice for blinded Phase 3 clinical trials, the interim analysis data are only reviewed by the IDMC.
The company, the regulatory authorities including the US Food and Drug Administration (FDA), and the trial investigators are blinded to treatment allocations, grouped safety and efficacy data for the ongoing trial and the data inputs into this interim analysis.
“We are absolutely delighted to have reached this important milestone. I would like to thank all of our patients for agreeing to be part of this trial to date, as well as our CRO and our amazing Dimerix team,” DXB managing director Dr Nina Webster said.
“We are now only a matter of days away from our Part 1 analysis outcome and, on the presumption of success, are continuing to prepare for Part 2 of the Phase 3 study.
“Success in Part 1 would signal that DMX-200 is performing better than placebo in reducing proteinuria, an important marker of kidney disease progression, in a larger cohort of patients than our prior Phase 2 study and validates our strategy and our prioritisation of this potentially valuable program.”
The second interim analysis is planned to be carried out after the first 144 patients complete about 35 weeks of treatment.
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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