NÎMES, France--(BUSINESS WIRE)--Regulatory News:
Advicenne (Paris:ADVIC), a specialist pharmaceutical company focused on the development of pediatric-friendly therapeutics for the treatment of orphan renal and neurological diseases, announces it has entered into a partnership with the European Society for Paediatric Nephrology (ESPN). This partnership, which will initially last for 3 years, will enable data collection on distal Renal Tubular Acidosis (dRTA) in Europe.
This collaboration will be marked by the opening of a survey on the management of dRTA in Europe (mainly covering the 5 largest European countries). The database will gather real-life data on health evolution and care process of 400 dRTA patients with primarily the genetic form of the disease in Europe. The database will be used to provide compelling information on patient journey, diagnostic, alternative treatments and complications arising from dRTA. Data collected will be published to publications with the objective to share its findings with the health community.
Elena Levtchenko, ESPN Secretary General comments: “This partnership reflects our willingness to improve the knowledge available around renal diseases that affect children, and in this case around dRTA. The information gathered will allow us to improve patient journeys and quality of care of patients affected by dRTA in Europe.”
« We are delighted to start this collaboration with ESPN. It reflects our global approach and vision to improve the quality of life of patients with a renal orphan disease.” said Luc-André Granier, co-founder and CEO of Advicenne.
Advicenne (Euronext: ADVIC) is a late-stage pharmaceutical company developing pediatric friendly therapeutics for the treatment of orphan renal and neurological diseases. The Company’s lead product is ADV7103, which has shown positive results in a European pivotal Phase III study in children and adults with distal Renal Tubular Acidosis (dRTA). Advicenne is planning to file ADV7103 for market authorization for dRTA in Europe in H2 2018 and anticipates its commercial launch around 2020 in Europe. A phase II/III clinical trial assessing ADV7103 in dRTA patients in the United States is expected to start in H2 2018. Commercial launch in the United States is anticipated around 2021.
ADV7103 is also being developed in a second indication, Cystinuria, an inherited renal tubulopathy. A pivotal Phase II/III clinical trial in patients with cystinuria is expected to start in 2018 in Europe.
Advicenne is listed on the regulated market of Euronext in Paris (ISIN: FR0013296746; Euronext ticker: ADVIC). The Company, which was established in 2007, is headquartered in Nimes (France).
For more information please visit: http://advicenne.com
About the European Society for Paediatric Nephrology
The European Society for Paediatric Nephrology (ESPN) is a network of hundreds of specialists from Europe, Russia and Turkey. This association aims to promote knowledge on renal pediatric diseases through various training and scientific events. The ESPN also organises annual conferences that gather the relevant health professionals.
About distal Renal Tubular Acidosis (dRTA)
dRTA is a disease that occurs when the kidneys do not properly remove acids from the blood into the urine. As a result, too much acid remains in the blood which generates an unbalanced pH that can lead to failure to thrive and rickets (a condition that affects bone development in children) as well as a range of additional clinical disorders such as a potassium deficiency (hypokalaemia) in the blood serum which alters the function of several organs and most prominently affects the cardiovascular system. In addition, a high concentration of calcium in the blood and urine (hypercalcemia and hypercalciuria) can lead to kidney stones and calcinosis that can potentially cause renal impairment, ultimately leading to renal failure. The disease, either genetic (usually occurring during childhood) or acquired as a result of autoimmune disease, is estimated to affect approximately 30,000-50,000 patients in Europe.