Advicenne Confirms ADV7103’ Safety and Efficacy after 24 Months in the Phase III Extension Study
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 preliminary results of the Phase III Extension Study (B22CS) with ADV7103 in Distal Renal Tubular Acidosis (dRTA). This open-label clinical study confirms the efficacy and safety of ADV7103 after 24 months of treatment.
Results from 90% of patients at 6 months, 12 months, 18 months, and 24 months demonstrate the ability of ADV7103 to normalize biological disorders caused by dRTA throughout the course of treatment. This efficacy, measured by blood bicarbonate levels and stabilized serum potassium, remains constant in about 80% of patients.
The safety profile of ADV7103 remains very favorable during the treatment, with only 15% of patients having reported digestive side effects considered as product-related, rated as mild for three patients and as medium for one patient.
Dr Luc André Granier, co-founder and CEO of Advicenne, says: “We are delighted with the progress in this study, in line with the schedule and these first results, which confirm the ADV7103 6-month efficacy and safety data presented at the ASN (American Society of Nephrology) in November 2017 ( press release ). These positive results will enable us to file a Marketing Authorization Application in Europe for ADV7103 and to offer an alternative to patients suffering from Distal Renal Tubular Acidosis.”
This B22CS extension study which comes on the heels of the Phase III pivotal clinical trial (B21CS), confirms the positive results of the B21CS study. ADV7103 has successfully met the primary and secondary endpoints of the Phase II/III pivotal study and demonstrates its ability to treat biological disorders caused by dRTA.
The preliminary positive results of this study pave the way for the company to file an AMM application in Europe for ADV7103 in the dRTA, an indication for which the European Commission granted ADV7103 the orphan drug designation in June 2017.
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 in the blood that can generate 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; and a high concentration of calcium in the blood and urine (hypercalcemia and hypercalciuria respectively) which 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 30 000 patients in Europe and 20 000 in the US.
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
Luc-André Granier / Sarah Delbaere / Julie Rachline
+33 (0)4 66 05 54 20
Caroline Carmagnol / Tatiana Vieira
+33 (0)1 44 54 36 66
US Investor Relations
Rx Communications, LLC
Glenn Garmont, 917-322-2569
Emmanuel Huynh / Alexia Faure
+33 (0)1 44 71 94 94
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Tilaa tiedotteet sähköpostiisi
Haluatko tietää asioista ensimmäisten joukossa? Kun tilaat mediatiedotteemme, saat ne sähköpostiisi välittömästi julkaisuhetkellä. Tilauksen voit halutessasi perua milloin tahansa.
Lue lisää julkaisijalta Business Wire
Rockwell Automation Opens Registration for 2018 Automation Fair18.9.2018 17:54 | Tiedote
Registration is now open for the 2018 Automation Fair, hosted by Rockwell Automation and members of its global PartnerNetwork program. The 27th annual Automation Fair will be held Nov. 12-15 at the Pennsylvania Convention Center. The event brings together approximately 10,000 manufacturers and producers from across the globe to learn about the newest innovations in automation and take part in training, industry forums and networking events. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180918005725/en/ Automation Fair will feature more than 150 exhibits showcasing the latest product innovations for industrial manufacturing and production. Hosted by Rockwell Automation and members of its PartnerNetwork, the event offers more than 400 hours of educational opportunities through forums, hands-on labs and technical sessions. (Photo: Business Wire) “The next industrial transformation is here – and meeting its demands requires a m
Seoul Semiconductor Supplies Optimal LEDs ‘SunLike’ to Large Scale Applications of Lumitronix in Germany18.9.2018 16:33 | Tiedote
Seoul Semiconductor Co., Ltd. (KOSDAQ 046890), a market leader in LED (light emitting diode) design and manufacturing, supplied the innovative LEDs “SunLike” to Lumitronix, the LED specialist located in Baden-Württemberg, Germany. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180918005626/en/ The Modules with SunLike LEDs. (Photo: Business Wire) In cooperation with Seoul Semiconductor, Lumitronix has also developed three optimal SunLike modules to provide customers with a standardized solution and expand its adoption in the lighting market. Two of the LED modules comply with the standard of Zhaga, a global association of lighting companies, for Book 7 L56W2 and Book 7 L28W2 and enable easy replacement in various industrial applications. The modules named LinearZ are available in one feet and two feet length. The model LinearZ 280-26 measures 280 mm and is equipped with 26 SunLike LEDs and has a light output of up to 700 lm.
Andersen Global Continues South American Expansion With BKM Berkemeyer18.9.2018 16:30 | Tiedote
Andersen Global announces further growth in South America with the signing of a Collaboration Agreement with BKM Berkemeyer, one of the oldest and largest law firms in Paraguay. With two locations in the capital city of Asunción, the firm has a headcount of nearly 150 professionals, including ten Partners and over 60 lawyers. Established in 1951, BKM Berkemeyer is led by Managing Partner Hugo Berkemeyer and provides legal solutions to both domestic and international clients. The firm delivers advice in all areas of law, including business and corporate, taxation, litigation, environment, employment and intellectual property, with a notable expertise in international transactions and business matters. BKM Berkemeyer also specializes in M&A’s, joint ventures, foreign investment, infrastructure, project finance and financial transactions, advising also on issues regarding telecommunications, water and energy projects. Hugo commented, “Our focus at BKM Berkemeyer has been to provide flexib
175 Million Europeans Have Sleep Apnoea, Highlighting Scale of Global Health Crisis18.9.2018 16:05 | Tiedote
Roughly 175 million Europeans have obstructive sleep apnoea, according to a late-breaking abstract presented by ResMed today at the European Respiratory Society’s annual ERS Congress in Paris. Leading researchers estimate 90 million Europeans have moderate to severe sleep apnoea, meaning they experience at least 15 breathing events an hour during sleep. These statistics are based on the latest scoring rules for determining one’s apnoea–hypopnoea index (AASM 2012) and are connected with a 16-country study announced in May 2018 that revealed an estimated 936 million people worldwide have sleep apnoea, a chronic sleep-disordered breathing condition associated with increased risk of mortality and reduced quality of life. The new global prevalence is nearly tenfold higher than the previous one – 100 million – estimated by the World Health Organization in 2007. European countries with the highest prevalence are: Russia, 40 million Germany, 26 million France, 24 million Ukraine, 13 million Sp
Veteran Gartner Analyst Pat Phelan Joins Rimini Street as VP of Market Research18.9.2018 16:00 | Tiedote
Rimini Street, Inc., (Nasdaq: RMNI), a global provider of enterprise software products and services, and the leading third-party support provider for Oracle and SAP software products, today announced the appointment of Pat Phelan as vice president of market research. In this new role, Phelan is responsible for research across the enterprise software market, including applications and technology strategies, software vendor support, third-party support, IT leadership trends and IT optimization. She also supports strategic planning, senior leadership discussions, business development and sales execution by providing enterprise software licensees with quantitative and qualitative strategic insights. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180918005304/en/ Veteran Gartner Analyst Pat Phelan Joins Rimini Street as VP of Market Research (Photo: Business Wire) “As a Gartner analyst, I closely followed Rimini Street since its
AGCO Launches AGCO Agriculture Foundation18.9.2018 16:00 | Tiedote
AGCO (NYSE: AGCO), a global leader in the design, manufacture and distribution of agricultural machinery and solutions, today announced the launch of the AGCO Agriculture Foundation. “The AGCO Agriculture Foundation is a testament to our commitment to support farmers feeding the world. Our objective is to support non-profit initiatives that contribute to global food security, support sustainable agriculture development and have an economic impact in developing countries,” said Martin Richenhagen, AGCO’s Chairman, President and CEO. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180918005073/en/ The new philanthropic focus demonstrates AGCO’s strong commitment to specific Sustainable Development Goals developed by the United Nations that seek to end hunger and provide basic necessities to a growing world population. AGCO has already been driving change globally, particularly in certain developing markets, by supporting farmer
Uutishuoneessa voit lukea tiedotteitamme ja muuta julkaisemaamme materiaalia. Löydät sieltä niin yhteyshenkilöidemme tiedot kuin vapaasti julkaistavissa olevia kuvia ja videoita. Uutishuoneessa voit nähdä myös sosiaalisen median sisältöjä. Kaikki STT Infossa julkaistu materiaali on vapaasti median käytettävissä.Tutustu uutishuoneeseemme