Posted: 12 September 2024
Dimerix Limited (ASX: DXB), a biopharmaceutical company with a Phase 3 clinical asset in kidney disease, is pleased to advise that the first clinical site specialising in paediatric kidney disease was activated today in Mexico. This now allows for the active recruitment of adolescent patients into the ACTION3 Phase 3 clinical trial.
This follows the Independent Data Monitoring Committee (IDMC), and subsequently the FDA and EMA (as part of the Company’s Paediatric Investigation Plan (PIP)), confirming that the dose of DMX-200 to be used in adolescent patients aged 12-17 years participating in the trial will be the same dose as provided to adults in the trial (120 mg twice daily). This determination was based on reviewing the aggregate interim safety and pharmacokinetic data, including simulations in adolescents, from the adult cohort of the ACTION3 Phase 3 trial taken at the first interim analysis point in March 2024 where the IDMC noted “the safety margin [of DMX-200] should allow [the ACTION3 Phase 3] clinical study to proceed in this adolescent population using adult doses”.
Of the approximately 170 planned ACTION3 clinical sites, approximately 15 are specialist paediatric kidney centres across the UK, USA, Mexico, Brazil and Argentina that have been selected to recruit a target population of approximately 22 paediatric/adolescent patients with FSGS into the ACTION3 study. Patients in this “adolescent or paediatric cohort” of the ACTION3 Phase 3 clinical trial will also be blinded, randomised (i.e. unknowingly placed on either placebo or DMX-200) and will be followed for a period of two years. Should the paediatric cohort be successful, and DMX-200 be approved in adults, it may allow Dimerix to expand its approval for DMX-200 and market DMX-200 to adolescents in key territories, including the US and Europe. FSGS is one of the leading causes of kidney failure in children, with 20% of all presentations of Nephrotic Syndrome in paediatric patients caused by FSGS.
Recruitment remains on-track with 116 patients out of the Part 2 target population of 144 having been randomised into the study, and the timing of the interim analysis expected around mid-2025 remains unchanged. It is important to note recruitment of patients into clinical trials is not linear and, as previously advised, the recruitment rate is expected to grow with the initiation of approximately 100 new trial sites, bringing the total number of clinical sites to approximately 170 globally.
The Company’s cash position to fund the ongoing ACTION3 Phase 3 clinical study, which consists of both the randomised adult and the paediatric cohort, remains strong and includes the Company’s cash reserves of $22 million at the end of June quarter4, the anticipated 2024 R&D tax incentive cash rebate of almost $8 million5 and the anticipated exercise of the $0.154 options(with an expiry of June 2025) that could bring in up to a further $7.6 million. Furthermore, the Company’s cash position does not include any potential milestone payments that become due under the Company’s existing licensing arrangements or potential up-front payments that may be received as part of future licensing deals. The Company continues to focus on licensing in other available territories including the US, which could represent up to 50% of the global FSGS opportunity alone, and China.
To support the ACTION3 study moving into paediatric patients, Dimerix has appointed Dr Howard Trachtman to the Medical Advisory Board. Dr Trachtman is a graduate of the University of Pennsylvania Medical School and completed a fellowship in paediatric nephrology at Albert Einstein College of Medicine. Dr Trachtman has had an outstanding career to date, including being Chief of the Division of Paediatric Nephrology at the Cohen Children’s Medical Center and at NYU Langone Health, and has been the Principal Investigator of multiple NIH and industry-sponsored clinical trials specifically in FSGS patients. Dr Trachtman’s clinical research consists of co-authoring over 195 peer reviewed articles in the kidney disease space in the past 15 years. Further, Dr Trachtman is a board member for the Kidney Health Initiative and on the editorial board of multiple journals including Kidney360, Glomerular Diseases, and Paediatric Nephrology.
