Business Wire

European Commission Grants Orphan Drug Designation to Allena Pharmaceuticals’ Investigational Therapy for the Treatment of Primary Hyperoxaluria

Jaa

Allena Pharmaceuticals, Inc., a specialty biopharmaceutical company dedicated to bringing first in class, specific, non-absorbed, oral enzyme therapeutics to patients with serious renal, urologic and orphan diseases, announced today that the European Commission has granted orphan drug designation to Allena’s investigational product ALLN-177, Bacillus subtilis oxalate decarboxylase, for the treatment of primary hyperoxaluria (PH). The orphan designation was granted to Allena Pharmaceuticals Ireland Limited, a subsidiary of Allena Pharmaceuticals, Inc.

Allena’s lead compound ALLN-177, is being developed to treat patients with severe hyperoxaluria, a condition characterized by markedly elevated urinary oxalate excretion. PH, a type of severe hyperoxaluria, is a rare genetic disorder caused by endogenous overproduction of oxalate by the liver that can result in kidney stone disease, kidney damage, and kidney failure, which may lead to death. PH has three main types, PH1, PH2 and PH3, and is estimated to affect approximately 0.1 in 10,000 people, which is roughly 5,000 people in the European Union (EU).1 The most severe and most common type among genetically characterized patients is PH1. These patients typically develop recurrent kidney stones, progressive renal damage, chronic kidney disease and end stage renal disease at a median age of 24 years of age.2 There are no EU approved therapies for PH, and the most severe patients may be treated with liver and/or kidney transplant.

ALLN-177 is a first-in-class therapeutic being developed to treat patients with severe hyperoxaluria using an oral, non-absorbed enzyme that works in the gastrointestinal (GI) tract, where it is designed to degrade both dietary and endogenously produced oxalate that is secreted into the GI tract. GI elimination of oxalate has potential to help alleviate the chronic systemic oxalate burden on PH patients.

“Primary Hyperoxaluria is a debilitating disease, which starts at a young age and leads to renal failure in young adulthood. It’s imperative that we have better therapeutic options to treat this disease,” said Eduardo Salido, M.D., Ph.D., Professor of Pathology at Universidad de La Laguna, Tenerife, Spain. Dr. Salido recently hosted the 12th International PH Workshop for Professionals, Patients and Families organized by the Oxalosis and Hyperoxaluria Foundation and is on the steering committee of Oxal Europe, the European Hyperoxaluria Consortium. Dr. Salido also co-authored a previous publication that demonstrated that oxalate decarboxylase significantly reduced urinary oxalate levels in a pre-clinical disease model of PH. This study was one of multiple animal studies including a rodent disease model and a porcine model of hyperoxaluria with hyperoxalemia that supported the ALLN-177 orphan drug designation application to the European Medicines Agency (EMA).

“This regulatory designation from the European Commission represents an expansion of our previous efforts in United States,” said Louis Brenner, M.D., President and Chief Operating Officer of Allena Pharmaceuticals. “We are excited to develop ALLN-177 to address the oxalate disease burden for PH patients in both the US and EU, where there are no US Food and Drug Administration or European Commission approved therapies for this unmet medical need.”

About Hyperoxaluria and ALLN-177

Hyperoxaluria is a metabolic disorder resulting from high oxalate levels in the urine due to either overproduction of oxalate by the liver due to a genetic defect (primary) or from hyper-absorption of oxalate from the diet (secondary). Secondary hyperoxaluria can be due to an unknown cause (idiopathic) or as a result of underlying GI disorders (enteric). Kidney stones are typically the first sign of hyperoxaluria, are often painful, and may require interventional procedures. Severe hyperoxaluria in settings of enteric and primary hyperoxaluria may also lead to kidney damage (nephrocalcinosis), chronic kidney disease and end-stage renal disease, which may lead to death.

ALLN-177 is an orally-administered, recombinant oxalate-degrading enzyme in development for the treatment of severe hyperoxaluria. ALLN-177 is being developed to target oxalate in the GI tract in an effort to reduce the burden of both dietary and endogenously produced oxalate. ALLN-177 has the potential to decrease the oxalate available systemically for deposition as calcium oxalate crystals or stones in the kidneys, as well as reduce long-term kidney complications. ALLN-177 is an investigational product, and its safety and efficacy have not been evaluated by the EMA or any other health authority.

About Allena Pharmaceuticals

Allena Pharmaceuticals, Inc. is a specialty biopharmaceutical company dedicated to bringing first in class, specific, non-absorbed, oral enzyme therapeutics to patients with serious renal, urologic and orphan diseases. Allena is completing a Phase 2 program in secondary hyperoxaluria. The company’s technological approach enables the design and development of oral enzyme therapies that are designed to remain in the gastrointestinal (GI) tract, where the enzyme exerts its therapeutic effect by degrading certain nephrotoxic metabolites, without being absorbed into the bloodstream. Led by a proven management team with deep expertise in enzyme therapeutic design, development, and commercialization, Allena is committed to bringing breakthrough new treatments to patients with unmet medical needs. Based in Newton, MA, the company is supported by a top-tier investor syndicate including Frazier Healthcare, Third Rock Ventures, Bessemer Venture Partners, HBM Partners, Pharmstandard International S.A., Partner Fund Management, Fidelity Management & Research Company, and other investors. For more information, please visit www.allenapharma.com (http://www.allenapharma.com).

References:

1. The European registry of orphan diseases (Orphanet 2013).
2. Cochat P., Rumsby G. Primary Hyperoxaluria. New England Journal of Medicine. 2013;369(7):649-658.

Contact information

Allena Pharmaceuticals, Inc.
Janet Giroux, 617-467-4577
Manager of Corporate Operations
jgiroux@allenapharma.com

Tietoja julkaisijasta

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 jo ennen kuin ne uutisoidaan? Kun tilaat tiedotteemme tältä julkaisijalta, saat ne sähköpostiisi yhtä aikaa suomalaisen median kanssa. Tilauksen voit halutessasi perua milloin tahansa.

Lue lisää julkaisijalta Business Wire

HCL Technologies Powers Volvo Ocean Race 2017-1823.10.2017 16:02Tiedote

The 2017-18 edition of the Volvo Ocean Race was flagged off at Alicante, Spain, with HCL Technologies as the strategic IT services provider. The leading global IT services company has provided end-to-end infrastructure support as well as connectivity between the Race Village and the Command Centre in Alicante further connecting them to 12 Host Cities on the race route globally. The world's longest and toughest professional sporting event began at Alicante and will finish eight months later at The Hague. At the flag-off, Jordi Neves, Chief Digital Officer, Volvo Ocean Race, said: “Over four decades, Volvo Ocean Race has drawn some of the greatest ever sailors. This edition of the race will be more digitally focused than before, with HCL as the strategic IT services provider. This edition is also special for us as we embark on a major Sustainability Program in partnership wi

CES Unveiled Paris Returns Tomorrow for Fifth Year with 70+ Exhibitors23.10.2017 16:00Tiedote

Consumer Technology Association (CTA):   WHAT:             CES Unveiled Paris returns to Paris tomorrow, for its fifth consecutive year, hosting more than 70 exhibitors. More than 600 attendees are expected at the event which will unite French tech startups, top media, buyers and industry influencers around the latest tech innovation and provide a preview of CES® 2018. Schedule as follows:  

Wipro Cited as a Leader in Everest Group PEAK Matrix™ for IT Security Services23.10.2017 15:59Tiedote

Wipro Limited (NYSE: WIT, BSE: 507685, NSE: WIPRO), a leading global information technology, consulting and business process services company, today announced that it has been recognized as a ‘Leader’ by Everest Group, a global independent consulting and research firm, in its report titled “IT Security Services- Market Trends and PEAK MatrixTM Assessment 2017: Security- the Biggest Digital Insecurity”. The report analyzed the capabilities of 17 leading global IT service providers on Everest Group’s PEAK Matrix. Wipro has been named as a Leader for its strong global delivery network with a transformational mind-set, and its ability to deliver high quality of services across regions and service segments, in terms of both execution and responsiveness. The report highlights the trends influencing the IT security services market, focusing on the increasing complexities, size and

ZeroStack Delivers Unified Multi-Cloud Application Development Platform Leveraging Existing Hardware Assets23.10.2017 15:00Tiedote

ZeroStack, Inc., creators of the self-driving on-premises cloud, today announced that its cloud platform now runs on Nutanix HCI hardware, expanding choices for IT departments that want to empower their DevOps groups with a software-defined infrastructure that offers SaaS-delivered, multi-cloud operations. Developers can have a consistent platform no matter where they are located while reducing operational complexity and costs. Developers need a common platform to reduce costs and ensure efficient processes for software development, and budget-constrained IT departments want to gain maximum leverage out of existing hardware. ZeroStack’s Intelligent Cloud Platform is hardware independent, so it enables consistent processes regardless of the hardware used or where the developers access the infrastructure. As a result, developers can create secure private workspaces and build a per

Biogen and Eisai Expand Existing Collaboration Agreement to Develop and Commercialize Investigational Alzheimer’s Disease Treatments Including Phase 3 Aducanumab23.10.2017 14:15Tiedote

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (NASDAQ: BIIB) (Headquarters: Cambridge, Massachusetts, United States, CEO: Michel Vounatsos, “Biogen”) announced today that the companies have expanded their existing agreement to jointly develop and commercialize investigational Alzheimer’s disease treatments. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20171023005462/en/ Under the terms of the agreement Eisai has exercised its option to co-develop and co-promote aducanumab, Biogen’s investigational anti-amyloid beta (Aβ) antibody for patients with Alzheimer’s disease (“AD”). The expanded agreement leverages each company’s respective geographic strengths for commercialization and adjusts the respective share of profits from potential sales of aducanumab. Biogen will receive 55

Open Letter from Mats Granryd, Director General, GSMA23.10.2017 14:01Tiedote

Dear Ministers, As you are no doubt aware, European citizens and businesses rely on mobile networks to socialise, do business and access information everyday in every corner of every Member State of the Union. The social and economic activity that rides over this digital infrastructure drives economic growth, shapes future innovation and fosters more inclusive societies. As you prepare to convene at tomorrow’s Ministerial Council Meeting, I must express my grave concerns on the current state of discussions on the proposed European Electronic Communication Code (the Code). Although the European Union’s vision of a ‘Gigabit Society’, and recent discussions amongst the European Heads of State, demonstrate a strong ambition to recapture the region’s digital leadership and harness the full power of digital to drive growth, jobs and competitiveness, we do not see action foc

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