Business Wire

Chugai's Bispecific Antibody Emicizumab to Present Results of Two Pivotal Phase lll Studies at ISTH

Del

Chugai Pharmaceutical Co., Ltd. (TOKYO:4519) announced results from two global phase lll studies for Chugai’s bispecific antibody emicizumab (ACE910): the primary analysis of HAVEN 1 study (NCT02622321) and the interim analysis of HAVEN 2 study (NCT02795767). The data will be presented on July 10 at the upcoming 26th International Society on Thrombosis and Haemostasis (ISTH) Meeting in Berlin, Germany (July 8 to 13). Both studies were conducted in haemophilia A with inhibitors, while HAVEN 1 is for adult and adolescent patients and HAVEN 2 is for paediatric patients.

HAVEN 1 Study

Study description

HAVEN 1 is a randomised, multicentre, open-label, global phase III study evaluating the efficacy, safety, and pharmacokinetics of emicizumab once-weekly subcutaneous injection for 24 weeks or longer in adults and adolescents (12 years of age or older) with haemophilia A with inhibitors to factor VIII.

Study design     n=109

  • Patients previously treated with on-demand bypassing agents (BPAs) were randomised in a 2:1 fashion to Arm A or B
        Arm A (n=35):       emicizumab once-weekly dosing
Arm B (n=18): no prophylaxis (on-demand BPA)
  • Patients previously treated with prophylactic BPA
        Arm C (n=49):       emicizumab once-weekly dosing
  • Patients who participated in a forgoing Non-Interventional Study (NIS) and previously on BPA (on-demand or prophylactic)
        Arm D:       emicizumab once-weekly dosing

On-demand use of BPAs was allowed to treat breakthrough bleeds per protocol in all arms.

Summary of results

  • The primary endpoint was achieved with a statistically significant reduction in bleed rate of 87% (risk rate [RR]=0.13, p<0.0001) in treated bleeds with emicizumab (Arm A) compared with on-demand treatment with BPAs (Arm B). All secondary endpoints were also achieved with consistent reductions in bleed rates.
       

[Major secondary endpoints and reduction rate (%) compared with on-demand BPAs]

All bleeds:       (80%, RR=0.20, p<0.0001)
Treated spontaneous bleeds: (92%, RR=0.08, p≤0.0001)
Treated joint bleeds: (89%, RR=0.11, p=0.0050)
Treated target joint bleeds: (95%, RR=0.05, p=0.0002)
  • After a median observation time of 31 weeks, 62.9% of patients receiving emicizumab experienced zero treated bleeds (Arm A) compared to 5.6% of those receiving on-demand BPAs (Arm B).
  • Results also showed a statistically significant improvement in health-related quality of life (HRQoL) measured at 25 weeks with emicizumab (Arm A) compared to on-demand BPAs (Arm B).
  • Among patients who had previously received prophylactic use of BPAs and then received emicizumab (Arm C), 24 patients had participated in the foregoing NIS, which was conducted without emicizumab. An intra-patient analysis in this group showed a 79% (RR=0.21, p=0.0003) reduction in treated bleeds receiving emicizumab compared to their prior prophylaxis with BPAs.
  • Adverse events (AEs) occurring in 5% or more of patients treated with emicizumab were injection site reactions, headache, fatigue, upper respiratory tract infection and arthralgia.
  • Serious adverse events were reported with thromboembolic events (TE) in two patients and thrombotic microangiopathy (TMA) in three patients (one patient experienced TMA after the clinical data cut off for primary analysis) while receiving emicizumab prophylaxis. The TE and TMA events were associated with repeated high doses of a BPA, activated prothrombin complex concentrate, when used to treat breakthrough bleeds.

HAVEN 2 Study

Study Description

HAVEN 2 is a single-arm, multicentre, open-label, global phase III study evaluating the efficacy, safety, and pharmacokinetics of emicizumab once weekly subcutaneous injection in paediatric patients with haemophilia A with inhibitors to factor VIII.

Interim analysis

The interim analysis was conducted with 19 children younger than 12 years of age with haemophilia A with inhibitors who require treatment with BPAs. The median observation time was 12 weeks.

Summary of results

  • Only one of 19 children receiving emicizumab reported a treated bleed. There were no reported joint or muscle bleeds.
  • An intra-patient comparison (n=8) in patients who were previously enrolled in the NIS showed that all patients experienced zero treated bleeds or a 100% reduction after emicizumab treatment (previous annualized bleeding rate ranged from 0 to 34.24); this included seven children who had received prior BPA prophylaxis, and one who had received prior on-demand BPA.
  • Data indicated that the same dose of emicizumab is appropriate for children as for adults and adolescents, based on the levels of emicizumab in the blood (pharmacokinetics) of the children compared with the level of emicizumab in the blood of adults and adolescents.
  • The most common AEs with emicizumab in the HAVEN 2 study were mild injection site reactions and common cold symptoms (nasopharyngitis).
 

Summary of the HAVEN 1 (NCT02622321) study results to be presented at ISTH

Study Description   Phase III randomised, multicenter, open-label study evaluating the efficacy, safety, and pharmacokinetics of emicizumab prophylaxis versus no prophylaxis in people with hemophilia A with inhibitors to factor VIII.
Patients

Patients with hemophilia A with inhibitors aged ≥12 years on episodic or prophylactic treatment with bypassing agent(s)
N=109

Study group  

No prophylaxis
(prior episodic BPAs)
(Arm B; n=18)

 

Emicizumab prophylaxis
(prior episodic BPAs)
(Arm A; n=35)

Treated bleeds ABR (primary endpoint)
Annualized bleeding rate [ABR]*

(95% CI)

23.3
(12.33; 43.89)

2.9
(1.69; 5.02)

% reduction (RR, p-value)

87% reduction
(RR= 0.13, p<0.0001)

Median ABR

(Interquartile range; IQR)

18.8
(12.97; 35.08)

0.0
(0.00; 3.73)

% patients with zero bleeds (95% CI)  

5.6
(0.1; 27.3)

 

62.9
(44.9; 78.5)

 

Treated bleeds ABR intra-patient comparison

(Arm C patients who participated in NIS n=24; secondary endpoint)

Study group   Prior prophylaxis with BPAs   Emicizumab prophylaxis
ABR*

(95% CI)

15.7
(11.08; 22.29)

3.3
(1.33; 8.08)

% reduction (RR, p-value)

79% reduction
(RR= 0.21, p=0.0003)

Median ABR (IQR)

12.0 [5.73; 24.22]

0.0 [0.00; 2.23]
% patients with zero bleeds  

12.5
(2.7; 32.4)

 

70.8
(48.9; 87.4)

*Negative binomial regression model

About Chugai

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 2016 of Chugai totalled 491.8 billion yen and the operating income was 80.6 billion yen (IFRS Core basis).
Additional information is available on the internet at https://www.chugai-pharm.co.jp/english.

Contact information

For Media
Chugai Pharmaceutical Co., Ltd.
Media Relations Group, Corporate Communications Dept.,
Koki Harada
Tel: +81-3-3273-0881
E-mail: pr@chugai-pharm.co.jp
***
For US media
Chugai Pharma USA Inc.
Casey Astringer
Tel: +1-908-516-1350
E-mail: pr@chugai-pharm.com
***
For European media
Chugai Pharma France SAS
Nathalie Leroy
Tel: +33-1-56-37-05-21
E-mail: pr@chugai.eu
***
For Taiwanese media
Chugai Pharma Taiwan Ltd.
Susan Chou
Tel: +886-2-2715-2000
E-mail: pr@chugai.com.tw
***
For Investors
Chugai Pharmaceutical Co., Ltd.
Investor Relations Group, Corporate Communications Dept.,
Toshiya Sasai
Tel: +81-3-3273-0554
E-mail: ir@chugai-pharm.co.jp

Om Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

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

GTIS Partners Clinches Sustainability Performance Top Honors for Third Year Running20.9.2017 13:32Pressemelding

GTIS Partners LP (“GTIS”), a real estate private equity firm headquartered in New York City, with offices in São Paulo, Los Angeles, San Francisco, Atlanta, Paris and Munich, today announced that the GTIS Brazil Real Estate Fund I has been recognized as 2017’s most sustainable private equity real estate investment fund in South America by the Global Real Estate Sustainability Benchmark (GRESB). This is the third year in a row that the fund has taken top honors. In addition, GRESB awarded GTIS Brazil Real Estate Fund II first place in the specialized category of non-listed real estate funds with hotel concentrations, and a number two ranking overall. GTIS Brazil Real Estate Fund III, which held its final closing in December 2016 with approximately $680 million in commitments, took third place. “GTIS Partners received another top honor with the #1 rank for South America in the

The Meet Group to Acquire LOVOO20.9.2017 12:31Pressemelding

The Meet Group, Inc. (NASDAQ:MEET), a public market leader in the mobile meeting space, today announced it has executed a definitive agreement to acquire LOVOO, a social dating app, for $70 million in cash, inclusive of a $5 million contingent earn-out. This acquisition furthers The Meet Group’s strategy to innovate, acquire, and build the largest mobile portfolio of brands for meeting new people. The LOVOO acquisition is expected to expand The Meet Group’s global footprint, increase the company’s scale and profitability, and diversify its business model by adding expertise in subscription and in-app purchasing. This Smart News Release features multimedia. View the full release here: http://www.businesswire.com/news/home/20170920005645/en/ LOVOO is a social and mobile technology company based in Germany: The #1 Dating App in German speaking countries (Ger

Arthur D. Little Urges Network Operators to Prepare for Next-Generation Internet of the GigaWorld20.9.2017 11:00Pressemelding

In its new report, “Unlocking GigaWorld Innovation: GigaApps in a GigaWorld,” Arthur D. Little (ADL) outlines the investment and monetization opportunities available to network operators ready to embrace the “GigaWorld”, the emerging third cycle of the internet. Defined by continuous and intelligent collaboration between individuals, devices and the built environment – and driven by applications in the areas of augmented reality, virtual telepresence and automated living – the GigaWorld has the potential to both power our economy and change the way we live. However, for it to be fully realized, network operators need to deliver improved Quality of Experience (QoE) for consumers and new Quality of Service (QoS) features for content and service providers. While operators have focused on delivering sufficient bandwidth and coverage to drive the current iteration of the internet, the GigaWorld

LINTEC Announces Four New Adhesive Materials for Labels20.9.2017 10:45Pressemelding

LINTEC Corporation (TOKYO: 7966) announced on September 20 that it will launch four newly developed label adhesive materials sequentially from October 2017. The new products will be on display prior to launch at Labelexpo Europe 2017, the world’s largest trade show in the label field. This Smart News Release features multimedia. View the full release here: http://www.businesswire.com/news/home/20170920005611/en/ LINTEC's super-strength adhesive labelstocks (Photo: Business Wire) Overview of Labelexpo Europe 2017 Date: September 25 (Mon.) to 28 (Thurs.) Venue: Brussels Expo, Belgium LINTEC Booth: Hall 3 3C 15 LINTEC Press Conference: 11:00 a.m. to 11:30 a.m., September 25, held in the Brussels Expo Press Office Theater Super-strength adhesive labelstocks: Extreme adhesion for rough surfaces Charac

EGS Invests in Artificial Intelligence from Quintiq20.9.2017 10:05Pressemelding

Quintiq, a Dassault Systèmes brand and global leader in supply chain planning and optimization (SCP&amp;O), announces that it has partnered with European Gateway Services (EGS) to bring a new level of intelligence to intermodal logistics. European Gateway Services (EGS) offers the market an integrated network for transport to and from the European hinterland. This Smart News Release features multimedia. View the full release here: http://www.businesswire.com/news/home/20170920005578/en/ EGS invests in artificial intelligence from Quintiq (Photo: Business Wire) To better support its customers, EGS takes standard planning strategies to a new level with a synchromodal trip optimizer using Quintiq’s planning and optimization software, which employs artificial intelligence to choose the optimal modes and routes at all times. Quintiq technology makes s

EchoStar 105/SES-11 Shipped from Toulouse to the Cape for SpaceX Launch20.9.2017 09:03Pressemelding

SES, EchoStar Corp., and Airbus Defence and Space announced today that the new EchoStar 105/SES-11 spacecraft, built by Airbus, has been shipped from the Airbus facilities in Toulouse, France, to Cape Canaveral, Florida, for its forthcoming launch by SpaceX in October. The first satellite that EchoStar has constructed with manufacturer Airbus, EchoStar 105/SES-11 will be launched by SpaceX on a flight-proven Falcon 9 rocket from Launch Complex 39A at Kennedy Space Center, Florida. This Smart News Release features multimedia. View the full release here: http://www.businesswire.com/news/home/20170920005539/en/ EchoStar 105/SES-11 Shipped from Toulouse to the Cape for SpaceX Launch (Photo: Business Wire) EchoStar 105/SES-11, a high-powered hybrid Ku and C-band communications satellite, is a dual-mission satellite for US-based operator EchoStar and Luxembourg-based

I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.

Besøk vårt presserom