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
Om Business Wire
(c) 2018 Business Wire, Inc., All rights reserved.
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
Følg saker fra Business Wire
Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.
Siste saker fra Business Wire
Schlumberger Announces Fourth-Quarter and Full-Year 2018 Results Conference Call16.11.2018 18:00 | Pressemelding
Schlumberger Limited (NYSE:SLB) will hold a conference call on January 18, 2019 to discuss the results for the fourth quarter and full year ending December 31, 2018. The conference call is scheduled to begin at 8:30 am US Eastern time and a press release regarding the results will be issued at 7:00 am US Eastern time. To access the conference call, listeners should contact the Conference Call Operator at +1 (800) 288-8967 within North America or +1 (612) 333-4911 outside of North America approximately 10 minutes prior to the start of the call, and ask for the “Schlumberger Earnings Conference Call.” A webcast of the conference call will be broadcast simultaneously at www.slb.com/irwebcast on a listen-only basis. Listeners should log in 15 minutes prior to the start of the call to test their browsers and register for the webcast. Following the end of the conference call, a replay will be available at www.slb.com/irwebcast until February 18, 2019, and can be accessed by dialing +1 (800)
Visa Strengthens Commitment to Growing Digital Payments in India16.11.2018 14:33 | Pressemelding
Visa (NYSE: V) today announced a minority investment in BillDesk, a leading platform for online payments and bill payments in India. Visa’s investment and collaboration will help BillDesk develop new product lines for its payments and loyalty businesses and also expand its footprint into other geographies. The investment will be subject to necessary statutory approvals and is expected to have no direct bearing on Visa’s existing Indian business. “As a leading payments player in India, BillDesk has been a long time business partner to Visa. Having worked with BillDesk’s founders over the years, the Visa leadership has been consistently impressed with their vision, market knowledge and execution capabilities, as well as alignment on values. This investment further reinforces our long-term commitment to India’s digital payments growth story,” said Asia Pacific regional president, Chris Clark. “We are truly excited by this investment from the world's largest global payment network, Visa. W
Guidewire Enhances PartnerConnect Consulting Program with Addition of Product and Regional Specializations16.11.2018 13:55 | Pressemelding
Guidewire Software, Inc. (NYSE: GWRE), provider of the industry platform Property and Casualty (P&C) insurers rely upon, today announced the addition of specializations to its PartnerConnect Consulting program. Specializations have been added to aid insurance companies in selecting the best partner to lead or staff their Guidewire projects. Guidewire unveiled new specializations, including two which have been successfully piloted earlier this year. “Our customers will now have more clarity and information as to which partners have the proven capabilities in their chosen product and region,” said Lisa Walsh, vice president, Alliances, Guidewire Software. “Adding these specializations will also allow us to have more insight into a partner’s performance and competencies.” To earn a specialization, partners need to demonstrate skills, knowledge, and competency in a specific Guidewire product or solution by certifying staff at multiple levels (specialist and professional) through Guidewire’
Janssen receives positive CHMP opinion for ERLEADA™ (apalutamide) for patients with non-metastatic castration-resistant prostate cancer who are at high risk of developing metastatic disease16.11.2018 13:15 | Pressemelding
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for apalutamide, a next generation oral androgen receptor inhibitor for the treatment of adult patients with non-metastatic castration-resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease.2 The CHMP’s positive opinion will now be reviewed by the European Commission (EC), which has the authority to grant approval for the use of apalutamide. The CHMP’s positive opinion is based on data from the pivotal SPARTAN Phase 3 clinical study which assessed the safety and efficacy of apalutamide versus placebo in patients with nmCRPC who have a rapidly rising prostate specific antigen (PSA) level despite receiving continuous androgen deprivation therapy (ADT). The SPARTAN clinical study showed that apalutamide, when added to ADT, significantly reduced the risk
Vertex Receives European CHMP Positive Opinion for ORKAMBI® (lumacaftor/ivacaftor) for Treatment of Children with Cystic Fibrosis Aged 2 to 5 Years Old with Most Common Form of the Disease16.11.2018 12:57 | Pressemelding
Vertex Pharmaceuticals (Europe) Limited today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for ORKAMBI® (lumacaftor/ivacaftor) for the treatment of people with cystic fibrosis (CF) aged 2 to 5 years old who have two copies of the F508del mutation, the most common form of the disease. If the European Commission issues a favorable adoption of the EMA CHMP opinion for the extension of indication, lumacaftor/ivacaftor will be the first and only medicine approved in Europe to treat the underlying cause of CF for patients aged 2 to 5 years old who have two copies of the F508del mutation. “Cystic fibrosis is a chronic, progressive disease and it is important to treat early to ensure the best possible outcomes for patients,” said Reshma Kewalramani, MD, Executive Vice President, Global Medicines Development and Medical Affairs and Chief Medical Officer at Vertex. “Today’s announcement brings us one step cl
Dimension Data Global Delivery Centre (GDC) in Prague wins the ABSL 2018 Diamond Award for Business Innovation16.11.2018 08:00 | Pressemelding
Dimension Data, the USD 8 billion global technology integrator and managed services provider, today announced that its Global Delivery Centre (GDC) in Prague has won the 2018 ABSL Diamond award for Business Innovation. The main purpose of this centre is to provide innovative, global service delivery capabilities and deep technical expertise to support our clients. The ABSL Diamond awards recognise companies that implement innovative projects, enhancing their business and strengthening the position of the business services sector. Every year, the aim is to identify successful activities in this sector and promote best practices, ultimately encouraging and inspiring others to follow suit. The ABSL celebrates initiatives that push business services forward and stand out as exemplary projects. Bill Padfield, Group Chief Operating Officer for Transformation and Services at Dimension Data, said: “Winning another award for our Support Services is a fantastic achievement. This time the ABSL Di