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Advicenne (Paris: ADVIC), a pharmaceutical company specializing in
development of child-friendly therapies for treatment
renal disease and neurological diseases, preliminary reports
Results of the Phase III Extension Study (B22CS) for ADV7103
Distal tubular renal acidosis (dRTA). This open clinical trial
confirms the efficacy and safety of ADV7103 after 24 months
Treatment.
The results of 90 percent of patients after 6 months, 12 months,
18 months and 24 months prove that ADV7103 as part of
The treatment caused the normalization of the biological dRTA
May cause interference. At the levels of bicarbonate in the blood and
Stabilized potassium levels in the serum measures the effectiveness remains
About 80% of patients are constant.
The safety profile of ADV7103 is very high throughout the therapy
cheap, because only 15 percent of patients reported digestive
Side effects, according to the medical opinion with the product in
Connection was standing. These reactions have been reported in three patients
mild and classified as moderate in a patient.
Dr. Luc André Granier, co-founder and CEO of Advicenne, said
to: "We are very excited about the progress of this
Study in accordance with the calendar and about it
first results showing the effectiveness of 6 months and
ADV7103 Security Data Confirmed at ASN Meeting
(American Society of Nephrology) were presented in November 2017 ( Press Release ).
On the basis of these positive results, we can make a
Submit a marketing authorization application for ADV7103 in Europe and for patients,
who suffer from distal renal tubular acidosis, an alternative
offer. "
The B22CS extension study immediately followed that
pivotal phase III clinical trial (B21CS)
the positive results of the B21CS study. ADV7103 has the primary and
secondary parameters of pivotal phase II / III trial
achieved and demonstrated that, therefore caused by biological dRTA
Disturbances can be treated.
The first positive results of this study pave the way for the company
the way, an application for marketing ADV7103 in
Europe to treat the dRTA. The European Commission
ADV7103 had the status of one of these indications in June 2017 for this indication
Orphan medication.
About renal distal tubular acidosis (dRTA)
dRTA is a
Disease that occurs when the kidneys do not have certain acids
correctly remove blood and excreted in the urine. then
too much acid remains in the blood, resulting in an unbalanced pH
blood, which in turn leads to stunting and rickets
(a disorder of bone development in children) and various other
clinical disorders. These include potassium deficiency
(Hypokalemia) in the blood serum, which modifies the function of several organs
and in particular the cardiovascular system is compromised as well as high
Concentration of calcium in the blood and urine (hypercalcemia or
Hypercalciuria) leading to kidney stones and calcinosis
Kidney damage may result in subsequent renal failure. the
The disease can be genetic (and usually childhood)
occur) or as a result of an autoimmune disease. In Europe
There are approximately 30,000 patients and 20,000 patients in the United States
affected.
About Advicenne
Advicenne (Euronext: ADVIC) is a
Pharmaceutical companies, pediatric therapeutics for the
Treatment of rare and neurological renal diseases developed.
The main product of the company, ADV7103, has positive results
in a pivotal European Phase 3 study with children
and adults with distal renal tubular acidosis (dTRA) and
In addition, for a second indication, cystinuria, hereditary
Renal tubulopathy, developed. Advicenne plans to file a
Application for marketing authorization for ADV7103 from dRTA in Europe in second place
The first half of 2018, and the market launch in Europe is for 2020
provided. A Phase II / III clinical trial evaluating ADV7103
in patients with dRTA in the United States is expected in the second
Start in the first half of 2018, and the market launch will be
Year 2021 expected. Advicenne is on the regulated market of
Euronext stock exchange in Paris (ISIN: FR0013296746 and Euronext: ADVIC)
note. The company has been in existence since 2007 and is headquartered in
Nîmes (France).
For more information, visit: http://advicenne.com
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