On November 21, 2018 i.e. today DXB has made an announcement that the European Commission after receiving highly positive views from the European Medicine Agency’s (EMA) Committee for Orphan Medicinal Products (COMP) in the month of October has finally given a designation to DMX200 as an orphan medicinal product used for the treatment of Focal Segmental Glomerulosclerosis (FSGS). FSGS is a rare type of chronic disease that impacts and attacks the kidney’s filtering units termed as glomeruli which causes serious scarring and ultimately leads to permanent damage to kidney or it results in the complete failure of kidney.
Receiving the designation of Orphan Drug (ODD) in Europe for such a rare chronic ailment FSGS has clearly demonstrated that Dimerix has well established and justified the intention for the treatment of FSGS with DMX-200. Dimerix has justified the fact by providing the preliminary non-clinical data which has clearly indicated the reduction in the number of podocytes lost and an improvement in proteinuria.
The European Medicine Agency has further supported the view that Dimerix has provided sufficient data and supporting results for DMX-200 and its usage will be of significant benefit to those who are already affected by such ailment and can be used as an alternative to the currently marketed products.
Receiving the designation of Orphan Drug (ODD) in Europe will provide regulatory and the financial benefits which will provide quick support to market DMX-200 in Europe. This designation will help in the overall reduction in the fees encountered during the product development phase, easy and direct access to the centralized marketing authorities in Europe and a 10-year market exclusivity after the product approval.
In December 2015, the United States Food and Drug Administration (FDA) has granted ODD to DMX-200 in the United States. With the current announcement, Dimerix is now having ODD for both the European and United States markets.
Currently patients are enrolled for two separate, concurrent Phase2 clinical programs conducted by Dimerix. DMX-200 for FSGS and DMX-200 for Diabetic kidney disease. Under the Phase 2a study for FSGS, around 10 eligible patients will be enrolled who will be receiving two treatment blocks of 16 weeks well separated by a 6-week washout period. During this treatment period patients will receive either placebo or DMX-200 under the first treatment block and will be switched to the alternative in the second treatment block. Each patient will be receiving daily 300mg of Irbesartan for approximately 3 months prior to screening, so that any drop in the proteinuria noticed during the trial can be solely attributed to DMX-200.Preliminary results from both the studies are expected to be released in Q4 calendar year of 2019.
Dr. Nina Webster, CEO of Dimerix (ASX: DXB), stated that receiving an orphan drug designation to DMX-200 for the treatment of FSGS from the European commission is a key regulatory milestone which will further drive all the clinical developmental programs. After the announcement the Dimerix shares moved slightly up and currently trading at the levels of $0.098 as at November 21, 2018.
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