Clinical-stage biopharmaceutical company Dimerix (ASX: DXB) has today announced that their current Phase 3 drug for kidney disease has been awarded an Innovation Passport and the Innovative Licensing and Access Pathway (ILAP).
The designation is awarded by the UK Medicines and Healthcare products Regulatory Agency and is designed to accelerate development of promising medicines to get them to market faster, allowing patients to benefit sooner.
Dimerix’s drug, DMX-200, is being studied as a treatment for the serious kidney disease focal segmental glomerulosclerosis (FSGS). The rare disease attacks the kidney’s filtering units and causes scarring, leading to permanent damage and ultimately, end stage kidney failure requiring dialysis or transplantation. Kidney failure occurs an average of five years post diagnosis.
Sadly, cases are on the rise with a compound annual growth rate of 8%. The poor prognosis of those with this disease coupled with the absence of pharmacologic treatment options leaves the door wide open for innovation.
Following receipt of Orphan Drug Designation from both the FDA and EMA (US and Europe) DMX-200 has progressed through the trial process. Orphan Drug Designation allows the drug to be used to treat rare diseases upon request of a sponsor prior to the drug receiving full regulatory approval. Orphan Drug status also comes with various development incentives including tax credits for qualified clinical testing.
Similar to Orphan Drug Designation, the ILAP comes after a review of clinical data that demonstrates the drug’s strong potential to benefit patients. The designation could see accelerated regulatory approval of the drug for patients in the UK.
CEO and Managing Director of Dimerix, Dr. Nina Webster said: “ The granting of the Innovation Passport and entry into ILAP comes in addition to the Orphan Drug designation we already have granted in both US and Europe. These designations ultimately accelerate the review of promising therapies targeting unmet medical needs.”
Dimerix will report on the results of their Phase 3 studies later this year.
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