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, saat ne sähköpostiisi yhtä aikaa suomalaisen median kanssa. Tilauksen voit halutessasi perua milloin tahansa.

Lue lisää julkaisijalta Business Wire

NBC Universal, Havas Group and Endemol Shine Discuss a Future with AI, Blockchain and VR at IBC201825.5.2018 21:20Tiedote

As is fitting for the home of technical invention and innovation, IBC2018 will present a broad range of ambitious and timely elements to engage, inform and inspire content creators and owners from around the world that will visit the RAI, Amsterdam from 13-18 September 2018. The must-attend event includes fresh inspiring conference themes that will focus on innovative new platforms, audience engagement and interaction/immersion, as well as a wide-ranging exhibition that will encompass all the latest technologies from AI and VR to advanced cloud-based workflows. Registration for IBC2018 is now open at: https://ibc.itnint.com/IBC18/Online/RegLogin.aspx “The media landscape is evolving at an unprecedented rate, with new platforms, technologies and even new realities at our disposal that offer greater opportunities for content innovation and audience engagement,” said Michael Crimp, CEO, IBC. “IBC is preparing an outstanding programme of conference sessions, forums and exhibition features

Pavilion of France at the 16th International Architecture Exhibition – La Biennale di Venezia25.5.2018 12:26Tiedote

The concept for Infinite Places , developed by the Encore Heureux team, led by the architects Nicola Delon, Julien Choppin, and Sébastien Eymard, presents places produced by new and inventive processes that generate architectural processes of value. This exhibition project, which considers the territory as a whole, highlights initiatives on the part of civil society and communities that embody a certain free spirit of experimentation and the possibilities opened up by architecture. These projects are expressions of programmatic freedom and generosity, and they live up to the theme of Freespace adopted by the two commissioners of the 16th International Architecture Exhibition – La Biennale di Venezia, the Irish architects Yvonne Farrell and Shelly McNamara. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180525005191/en/ French Pavilion Venice Architectural Biennale, copyright S. Scher Statement of the curators « Through the I

SIA Acquires Card Processing Businesses in Central and Southeastern Europe from First Data25.5.2018 11:30Tiedote

SIA, a European high-tech leader in payment infrastructure and services, and First Data Corporation (NYSE: FDC), a global leader in commerce-enabling technology, have signed an agreement for SIA to acquire First Data’s card processing businesses in parts of Central and Southeastern Europe for €375 million. In 2017, these businesses generated a combined revenue of approximately €100 million for First Data. This acquisition by SIA provides card processing, card production, call center and back-office services, including 13.3 million payment cards, 1.4 billion transactions, in addition to the management of POS terminals and ATMs. These businesses are primarily located in 7 countries: Greece, Croatia, Czech Republic, Hungary, Romania, Serbia and Slovakia. As a result of the transaction, SIA will become a leading player in processing and services in the region. The agreement includes the transfer of about 1,400 First Data employees into SIA. “This acquisition is in line with our strategy to

BRIC HOLDING Offers Aimedis – ICO: Germany’s Leading eHealth Platform Goes Public25.5.2018 09:00Tiedote

Since Wednesday, May 16, investors finally have a chance to claim their share of a unique success story, the international market roll-out of Aimedis, by purchasing AIM tokens: AIM tokens are now available with a 20% presale bonus PLUS a 5% early bird-premium only at the Czech investment house BRIC INVEST https://www.bric-holding.com/home_en.html! Aimedis aims to shape the future of healthcare by providing an advanced and fully operational platform, secured by blockchain and supported by AI, that enables patients to take control, secure the exchange of their medical data, access the best healthcare providers, get advice, prescriptions, personal health upgrades and to become part of the health revolution. And we are not talking about the future: The revolutionary Aimedis platform is already deployed as a live working system and is already in use in major hospital groups in Germany! By issuing 300 million AIM tokens at a nominal value of 0,12 USD each, the Aimedis consortium will raise c

Westinghouse Accident Tolerant Fuel Development Moves Forward with Cooperation Agreement with ENUSA25.5.2018 09:00Tiedote

Westinghouse Electric Company today announced that it will collaborate in the development of its EnCore® Fuel, the revolutionary accident-tolerant fuel (ATF) design, with ENUSA Industrias Avanzadas (ENUSA) through a Frame Cooperation Agreement (FCA). “This agreement serves to strengthen the technical and commercial relations between ENUSA and Westinghouse as we work to develop leading nuclear fuel technology,” said Torbjörn Norén, European Fuel Group and EMEA Fuel Delivery Director at Westinghouse. “Westinghouse’s work with ENUSA in the Spanish and European Fuel Group markets will help to facilitate agreements with customers to launch EnCore Fuel demonstration programs in their plants.” Under the terms of the agreement, the newly signed FCA establishes the framework that will regulate the different Joint Development Programs (JDPs) to be launched between both companies. The first JDP will evaluate the application of the segmented rod concept and develop models of ATF / EnCore fuel beha

Alps Electric to Acquire Greina Technologies, Inc. as Part of Sensor Business Strengthening25.5.2018 05:33Tiedote

Alps Electric Co., Ltd. (TOKYO: 6770; President: Toshihiro Kuriyama; Head Office: Tokyo) today announces that on May 14, 2018 the company signed a share purchase agreement with Greina Technologies, Inc. (Salt Lake City, Utah, U.S.A.; President/CTO: Daniel J. Lee) whereby Alps Electric will acquire Greina Technologies, making it a wholly owned subsidiary. Alps Electric signed a share purchase agreement with Greina Technologies on May 14, 2018. Through the agreement, Alps Electric aims to add even greater value to its sensing solutions for the automotive market, as well as the consumer electronics and mobile market, by combining high-accuracy positioning technology based on original algorithms developed by Greina Technologies with Alps Electric’s compact, high-performance wireless communication module technology. An engineering firm specializing in positioning systems, Greina Technologies was established in Salt Lake City, Utah, in September 2012. Engaging in such activities as design an

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