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
Kalray Releases the Kalray Neural Network 3.0 (KaNN) to Accelerate Artificial Intelligence Application Development13.11.2018 21:26 | Tiedote
Kalray (Euronext Growth Paris – ALKAL), a pioneer in processors for new intelligent systems, today announced the launch of the Kalray Neural Network 3.0 (KaNN), a platform for Artificial Intelligence application development. KaNN allows developers to seamlessly port their AI-based algorithms from well-known machine learning frameworks including Caffe®, Torch® and TensorFlow® onto Kalray’s Massively Parallel Processor Array (MPPA®) intelligent processor. Artificial Intelligence is at the heart of a growing number of applications such as autonomous vehicles, intelligent storage servers, data centers, robotics, drones, and more. Kalray’s manycore MPPA® intelligent processor has been architected from the ground up to meet the incredible performance requirements of such advanced applications. However, it is crucial to provide an easy way for AI developers to seamlessly support the AI networks they develop. “The Kalray MPPA® intelligent processor is capable of processing massive amounts of d
Sharjah International Book Fair 2018 Celebrates Reading and Culture with 2.23 Million Visitors13.11.2018 21:17 | Tiedote
The world’s third largest celebration of the written word, the Sharjah International Book Fair (SIBF), has put up yet another record performance in its 37th annual edition. Themed ‘A Tale of Letters’, the event was a dream come true occasion for book lovers, who had access to 20 million books, all under one roof. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20181113006044/en/ Sharjah International Book Fair 2018 - Provided by Sharjah Book Authority (Photo: Business Wire) Organised by the Sharjah Book Authority (SBA) in the emirate of Sharjah, cultural capital of the United Arab Emirates (UAE), SIBF 2018 witnessed a footfall of 2.23 million visitors in 11 days, including 230,000 school students who poured in from around the country. The Sharjah International Book Fair hosted 1,874 publishers from 77 countries who brought in 1.6 million titles, 80,000 of which were seen at the fair for the first time. It also offered its stage
Communications and Business Transformation Strategist Brian Ellner Joins BCW to Lead U.S. Corporate Practice13.11.2018 21:00 | Tiedote
BCW (Burson Cohn & Wolfe), a leading global communications agency, announced today that Brian Ellner has joined as Executive Vice President, Global Corporate Solutions, responsible for leading and growing BCW’s U.S. Corporate Practice. Ellner takes on the role previously held by Aranthan “AJ” Jones II, who will now lead the firm’s Public Affairs and Crisis Practice in the U.S. “Corporations are navigating an increasingly complex world where their reputations are tied not only to their own performance but also to their behavior on topics like climate, gender pay equity, visa status, diversity and inclusion and the environment,” said Chris Foster, President, North America, BCW. “Brian has deep experience helping clients build and protect their reputations, manage business transformation and create authentic social purpose engagements. He is a seasoned strategic counselor and power player in the New York business world and will bring our clients and our business clear opportunities for gr
Alliance Ventures Invests in Enevate to Advance Li-ion Battery Technology for Electric Vehicles13.11.2018 19:00 | Tiedote
Alliance Ventures, the strategic venture capital arm of Renault-Nissan-Mitsubishi, has announced today that it has invested in the latest round of funding in Enevate Corporation, an advanced lithium-ion (Li-ion) battery technology company based in Irvine, California. This marks the latest technology investment by Alliance Ventures, launched earlier this year to support start-ups, early-stage development, and entrepreneurs at the cutting edge of next-generation systems for the automotive industry. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20181113005136/en/ Francois Dossa, Alliance Global Vice President, Ventures and Open Innovation, said: “We are pleased to participate in Enevate’s latest funding round. This strategic investment allows us to support the development of Enevate’s proprietary, cutting-edge electrode technology. Continued development in this critical field will help us accelerate the electrification of our ve
P&G Tackles Clean Water, Gender Equality and Plastic Waste in 2018 CSR Report13.11.2018 17:05 | Tiedote
The Procter & Gamble Company (NYSE:PG) extends its long history of doing good in the world by bringing the comforts of home to those impacted by disasters, continuing to spark conversations about diversity, inclusion and gender equality with its advertising and making meaningful impact on the environment with new 2030 goals including a vision to ensure that none of the Company’s packaging ends up in the world’s oceans. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20181113005694/en/ P&G issued its 2018 Citizenship Report, which highlights the Company's progress in its Citizenship priority areas of Community Impact, Diversity & Inclusion, Gender Equality and Environmental Sustainability, all of which are based in a foundation of Ethics and Corporate Responsibility. (Graphic: Business Wire) Captured in the 2018 Citizenship Report released today, P&G highlights the recent activities that define the Company as a force for good an
ISACA Refreshes COBIT Framework to Address Latest Business Technology Trends and Standards13.11.2018 17:03 | Tiedote
ISACA, the global association for information and technology (I&T) audit, risk, governance and security professionals, has released its first update to the COBIT framework in nearly seven years. The new version, COBIT® 2019, provides comprehensive and more practical guidance to help enterprises better govern and manage their information and technology. The COBIT framework is used by enterprises in all industries around the globe, and COBIT publications have been downloaded more than one million times. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20181113005757/en/ ISACA introduced COBIT in 1996 to provide and organize a set of controls for IT. The new iteration of COBIT will come in four phases and will include focus areas reflecting trends and priorities in technology (e.g., DevOps, cybersecurity), updates aligned with the latest industry standards, and a design guide that provides flexibility and guidance to help organizat
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