Chugai's Bispecific Antibody "Emicizumab" for Hemophilia A Meets Primary Endpoint in Phase lll Study
Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced today that the primary endpoint has been met for the global phase lll HAVEN 1 study evaluating emicizumab (ACE910) prophylaxis for once-weekly subcutaneous injection with patients 12 years of age or older with hemophilia A and inhibitors to factor Vlll. A statistically significant reduction in the number of bleeds was confirmed in patients treated with emicizumab prophylaxis compared to those receiving no prophylactic treatment. The study also met all secondary endpoints, including a statistically significant reduction in the number of bleeds over time with emicizumab prophylaxis treatment in an intra-patient comparison in people who had received prior bypassing agent prophylaxis treatment. The most common adverse events with emicizumab were injection site reactions, consistent with prior studies.
“This result indicates that emicizumab could be a transformative advancement in the treatment for hemophilia A,” said Chugai’s President & COO, Tatsuro Kosaka. “We are committed to delivering emicizumab worldwide as a first-in-class biologic as early as possible, particularly to patients with inhibitors who have few treatment options.”
As previously reported, two patients had thromboembolic events and two patients developed thrombotic microangiopathy (TMA). The common aspect between all cases of thromboembolic events and TMA is that they occurred in patients who were on emicizumab prophylaxis and in addition received activated prothrombin complex concentrate to treat breakthrough bleeds. Neither thromboembolic event required anti-coagulation therapy and one patient restarted emicizumab. Both cases of TMA have completely resolved, and one patient restarted emicizumab.
Emicizumab is an investigational bispecific monoclonal antibody, which was developed using Chugai’s proprietary antibody engineering technologies. The drug is designed to bind factors lXa and factors X, and promotes the interaction between factors lXa and factors X. In doing so, emicizumab provides the cofactor function of factor Vlll in people with hemophilia A, who either lack or have impaired coagulation function of factor Vlll1,2). In 2015, the drug was granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) for prophylactic treatment for patients aged 12 years or older with hemophilia A with factor VIII inhibitors.
HAVEN 1 is the first global phase lll study in the emicizumab clinical development program to report results. Data from the study will be presented at an upcoming medical meeting.
About HAVEN 1 study (NCT02622321)
HAVEN 1 study is a randomized, multicentre, open-label phase lll study evaluating the efficacy, safety and pharmacokinetics of emicizumab prophylaxis for once-weekly subcutaneous injection. The study enrolled 109 patients with hemophilia A, 12 years of age or older with inhibitors to factor Vlll, who were previously treated with episodic or prophylactic bypassing agents. The primary endpoint of the study is the number of bleeds over time with emicizumab prophylaxis (Arm A) versus no prophylaxis (Arm B). Secondary endpoints include all bleed rate, joint bleed rate, spontaneous bleed rate, target joint bleed rate, health-related quality of life (HRQoL)/ health status, intra-patient comparison to bleed rate on their prior prophylaxis regimen with bypassing agents (Arm C) and safety.
Patients previously treated with episodic bypassing agents were
randomized in a 2:1 fashion to either Arm A or B.
Arm A: receive emicizumab prophylaxis for once-weekly subcutaneous injection
Arm B: receive episodic bypassing agents as same as previous treatment
Patients previously treated with prophylactic bypassing agents were enrolled in:
Arm C: receive emicizumab prophylaxis for once-weekly subcutaneous injection
Patients previously treated with episodic bypassing agents and participated in the non-interventional study (BH29768) prior to HAVEN 1 entry, and were unable to enroll in Arm A or Arm B were enrolled in:
Arm D: receive emicizumab prophylaxis for once-weekly subcutaneous injection
About emicizumab clinical development status
In addition to HAVEN 1, two pivotal clinical studies are currently underway by Chugai, Roche and Genentech.
- For children younger than 12 years of age with factor Vlll inhibitors (HAVEN 2)
- For people 12 years of age and older without factor Vlll inhibitors (HAVEN 3)
Chugai Pharmaceutical is one of Japan’s leading research-based
pharmaceutical companies with strengths in biotechnology products.
Chugai, based in Tokyo, specializes in prescription pharmaceuticals and
is listed on the 1st section of the Tokyo Stock Exchange. As an
important member of the Roche Group, Chugai is actively involved in R&D
activities in Japan and abroad. Specifically, Chugai is working to
develop innovative products which may satisfy the unmet medical needs,
mainly focusing on the oncology area.
In Japan, Chugai’s research facilities in Gotemba and Kamakura are collaborating to develop new pharmaceuticals and laboratories in Ukima are conducting research for technology development for industrial production. Overseas, Chugai Pharmabody Research based in Singapore is engaged in research focusing on the generation of novel antibody drugs by utilizing Chugai’s proprietary innovative antibody engineering technologies. Chugai Pharma USA and Chugai Pharma Europe are engaged in clinical development activities in the United States and Europe.
The consolidated revenue in 2015 of Chugai totalled 498.8 billion yen and the operating income was 90.7 billion yen (IFRS Core basis).
Additional information is available on the internet at http://www.chugai-pharm.co.jp/english.
1) Kitazawa, et al. Nature Medicine 2012; 18(10): 1570
2) Sampei, et al. PLoS ONE 2013; 8: e57479
Chugai Pharmaceutical Co., Ltd.
Media Relations Group, Corporate Communications Dept.,
Chugai Pharmaceutical Co., Ltd.
Investor Relations Group, Corporate Communications Dept.,
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
Rimini Street Announces $140 Million Refinancing18.6.2018 21:30 | Pressemelding
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 it has entered into a binding agreement with a syndicate of investors, including a fourth round of equity participation by Rimini Street’s largest shareholder, Adams Street Partners, to refinance its current credit facility with the issuance of $140 million of Series A convertible preferred stock and 2.9 million shares of common stock. Closing is subject to a shareholder vote and certain other customary closing conditions. Holders of a majority of the Company’s common stock have agreed to vote in favor of the transaction, and the Company expects the transaction to close in the third quarter of 2018. The transaction is expected to unlock more than $95 million of cash flow over the next three years as compared to the current credit facility. The transaction extends the expected financing matu
Quanergy to Feature ‘Qortex for Security’ at IFSEC18.6.2018 20:30 | Pressemelding
Quanergy Systems, Inc., a global leader in the design and development of solid state LiDAR sensors and smart sensing solutions, today announced that it will be demonstrating its LiDAR-based security system at multiple booths during IFSEC International, Europe’s premier security trade show. This year’s conference will take place June 19-21, 2018 in London, UK. Quanergy’s security system, Qortex for Security, is an innovative, LiDAR-based 3D perimeter fencing and intrusion detection system. An integrated hardware and software platform, this intelligent security solution combines Quanergy’s M8 mechanical LiDAR sensor with its proprietary Qortex perception software. The platform is fully integrated into existing VMS (Video Management System) and PSIM (Physical Security Information Management) infrastructure and offers surveillance automation with real-time people detection, tracking and classification. “Qortex for Security is a prime example of the many benefits that LiDAR hardware and sof
Inside Secure to Provide Secure Provisioning Solutions to NationalChip18.6.2018 15:35 | Pressemelding
Regulatory News: Inside Secure (Paris:INSD), at the heart of security solutions for mobile and connected devices, announced it entered into an agreement with Hangzhou NationalChip Science and Technology Co., Ltd, a leading innovator and developer of SoCs (system-on-chip), to use Inside Secure’s Secure Provisioning Solution to build robust security into its products during the chip manufacturing process. Secure provisioning is recognized as a crucial, foundational security building block across diverse markets including automotive, entertainment, IoT, mobile and TV. Securing devices or end products can be worthless if their identities and cryptographic keys have been compromised during manufacturing. Widely-publicized attacks have targeted provisioning because they can affect large numbers of devices and are difficult to detect. Chipmakers and device manufacturers see the potential for new revenue sources by offering secure provisioning to their customers, leveraging technology solution
Citi Private Bank Congratulates Fernando Alonso on the 24 Hours of Le Mans Win18.6.2018 14:01 | Pressemelding
Citi Private Bank ardently congratulates Fernando Alonso for his impressive win at The 24 Hours of Le Mans this past weekend. Mr. Alonso, who is also a two time Formula One World Champion, most recently competed and won the Six Hours of Spa-Francorchamps in May. In January he debuted at the Rolex 24 at Daytona. Previously he participated in the Indianapolis 500 in May of 2017. He was sponsored by Citi Private Bank for all four races. Alongside the Indianapolis 500 and the Monaco Grand Prix, Le Mans makes up one third of ‘the Triple Crown of Motor Racing’. Having already won Monaco twice, Mr. Alonso is on a quest to become only the second driver in history to complete the Triple Crown. “Fernando drove one the most thrilling races at Le Mans that I have ever seen. His stunning night time drive will likely go down as one of the greatest victories in motorsport’s history,” said Peter Clive Charrington, Global Head of Citi Private Bank. “Fernando possesses an unrelenting drive toward excell
Inteva Products Receives Top Innovation Award for Revolutionary Stitching Process18.6.2018 13:31 | Pressemelding
Inteva Products, LLC, a leading global Tier One automotive supplier of engineered components and systems, received the top prize in the 2018 Innovation Awards presented by the European Association of Automotive Suppliers (CLEPA) at The Hague, Netherlands, on June 13. Inteva was recognized for its new real-time scanning process for the robotic stitching of automotive interiors. This innovative technology will be used on instrument panels for the 2019 Chevrolet Silverado and GMC Sierra pickup trucks. The new process enables “live” scanning and immediate adjustments to the program path of robotic stitching equipment as a component is being stitched. This approach aligns leading-edge advances in the use of lasers in automotive manufacturing with Inteva’s unique robotic stitching technologies. The advancement reduces the average cycle time of a stitched surface by approximately 20-30%. The 2018 CLEPA Innovation Awards, organized in cooperation with Deloitte, celebrate automotive excellence
P&G Advances Systemic Change for Gender Equality in Advertising at 2018 Cannes Lions Festival of Creativity18.6.2018 12:25 | Pressemelding
The Procter & Gamble Company (NYSE: PG) today advanced its commitment to gender equality through a series of new actions, commitments and partnerships to increase diversity throughout the creative supply chain, leading to more accurate and positive portrayals of women in advertising and media, and driving growth and social good. Women and girls are inaccurately or negatively portrayed in 29 percent of ads and media programs*, and women continue to be underrepresented behind the camera: only 32 percent of Chief Marketing Officers, 33 percent of Chief Creative Officers and a mere 10 percent of Commercial Directors are women. These issues persist despite evidence that gender-equal ads perform 10 percent higher in trust and 26 percent higher in sales growth*. To address these issues, P&G has called for an aspiration to achieve 100% accurate and positive portrayals of women in advertising and media, supported by equal representation of women and men in the creative supply chain. P&G is lead