NÎMES, France--(BUSINESS WIRE)--Regulatory News:
Advicenne (Paris:ADVIC) (Euronext: ADVIC), a specialist pharmaceutical company focused on the development of pediatric-friendly therapeutics for the treatment of orphan renal and neurological diseases, announces that the results from a comparison study of ADV7103 versus standard of care (SOC) in patients with Distal Renal Tubular Acidosis (dRTA) will be presented at the 55th ERA-EDTA Congress, which is being held May 24-27, 2018 in Copenhagen, Denmark.
The poster presentation details are as follows:
Title: Reduction of the Number of Daily Intakes and Improved
Blood Bicarbonate Levels in Distal Renal Tubular Acidosis (dRTA)
Patients: Interest of ADV7103, a New Prolonged-Release Formulation
Poster number: FP001
Date: Friday, May 25, 2018
Time: 9:30am-10:45am and 4:30pm-5:00pm CEST
Location: Bella Center Copenhagen (ground floor, Center Hall E)
“This study demonstrates that ADV7103 with twice daily dosing regimen normalizes blood bicarbonate levels in most dRTA patients. In contrast, despite a high number of daily intakes in the Standard of care arm, blood bicarbonate levels were only adequately restored in a limited number of patients,” said Dr. Luc-André Granier, co-founder, chief executive officer and medical director of Advicenne. “If mistreated, dRTA can have devastating long-term health consequences, including kidney damage, softening of the bones and muscle weakness. We believe that ADV7103 represents a significant advance in the treatment of this rare but serious nephrological condition, and we look forward to bringing this new therapy to dRTA patients.”
This poster describes the results of a multi-center, open-label, non-inferiority, sequential study of ADV7103 versus SOC in patients with dRTA. Treatment of dRTA involves restoring physiological blood bicarbonate levels. In this study, patients were administered SOC for five days, and then switched to ADV7103 for five days. A total of 81% of patients treated (n=31 patients) with ADV7103 twice daily achieved physiological blood bicarbonate levels ≥ 22 mM, versus only 29% of patients on SOC, despite the high number of daily treatment (up to 6 times a day). In addition, 78.8% of patients treated with ADV7103 registered no gastro-intestinal (GI) complaints, versus 54.5% for SOC. A single GI adverse event was observed in the ADV7103 group, versus five GI events in the SOC group.
With more than 7,500 members, the ERA-EDTA (European Renal Association – European Dialysis and Transplant Association) is one of the largest nephrology associations worldwide, and among the most important and prestigious European Medical Associations overall. It supports basic and clinical research in the fields of clinical nephrology, dialysis, renal transplantation and related subjects. It also supports a number of studies as well as research groups. ERA-EDTA is a member of the European Kidney Health Alliance (EKHA), a consortium of patients, nurses and foundations relating to renal issues that actively interacts with the European Parliament.
For more information, please visit www.era-edta.org.
Advicenne (Euronext: ADVIC) is a pharmaceutical company developing paediatric friendly therapeutics for the treatment of orphan renal and neurological diseases. The Company’s lead product is ADV7103 which has demonstrated positive results in a European pivotal Phase 3 study in children and adults with distal Tubular Renal Acidosis (dTRA), is also being developed for a second indication, Cystinuria, an inherited renal tubulopathy. Advicenne is planning to file ADV7103 for market authorization for dRTA in Europe in H2 2018 and anticipates its commercial launch in 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 in 2021. 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 Nîmes, France.
For more information please visit: http://advicenne.com
This press release contains certain forward-looking statements relating to the business of Advicenne, which shall not be considered per se as historical facts. Such statements include estimates for future performance and estimates regarding anticipated operating losses, future revenues, capital requirements, needs for additional financing. In some cases, you can identify forward-looking statements by words such as "could," "should," "may," "expects," "anticipates," "believes," "intends," "estimates," "aims," "targets," or similar words. Although the management of Advicenne believes that these forward-looking statements are reasonably made, they are based largely on the current expectations of Advicenne as of the date of this press release and are subject to a number of known and unknown risks and uncertainties and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievement expressed or implied by these forward-looking statements. In particular, the expectations of Advicenne could be affected by, among other things, uncertainties involved in the placing on the market and commercialization of Advicenne products or any other risk and uncertainties developed or identified in any public documents filed by Advicenne with the AMF, included those listed in chapter 4 “Risk factors” of its document de base filed with the French financial market authority (the Autorité des marchés financiers) on October 31, 2017 under number I.17-071. Notwithstanding the compliance with article 223-1 of the General Regulation of the AMF (the information disclosed must be “accurate, precise and fairly presented”), Advicenne disclaims any intention or obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.
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