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诺和诺德N9-GP Paradigm项目首个III期试验取得积极数据

来源:生物谷 2013-05-21 16:23

2013年5月21日讯 /生物谷BIOON/ --诺和诺德(Novo Nordisk)上周五宣布,有关长效FIX衍生物N9-GP(糖基化重组凝血因子IX)Paradigm项目首个III期试验Paradigm-2已经完成。Paradigm-2是一项多中心、双盲实验,在B型血友病患者中开展,评价了将N9-GP作为按需(on-demand)或预防性(prophylactic)药物用于B型血友病治疗时的安全性和疗效。

该项试验中,74例患者接受按需治疗或接受12个月的预防性治疗(每周一次,40U/周或10U/周)。按需治疗组,平均出血发作为15.6次/年。预防性治疗时,40U/周和10U/周治疗组,平均出血发作分别为1.0/年和2.9次/年。

药代动力学数据表明,N9-GP的稳态(steady-state)半衰期为110小时。

该项试验中,N9-GP具有良好的安全性和耐受性属性,N9-GP治疗组中没有患者产生抑制剂,各个治疗组不良事件及标准安全参数无显着差异。

诺和诺德预计,Paradigm项目中分别在儿科患者和接受手术治疗的患者开展的2项III期临床试验,将在未来1年内完成。

诺和诺德已计划于2015年向全球主要的监管机构提交N9-GP的监管申请书。

有关N9-GP:是一种专有的糖基化重组IX因子,用于B型血友病患者的治疗。糖基化技术能够增加重组凝血因子IX的循环半衰期,能够减少静脉给药次数,并降低出血发作频率。(生物谷bioon.com)

英文原文:Novo Nordisk reports positive results from first phase 3 trial with long-acting factor IX for treatment of haemophilia B

Denmark, 17 May 2013 - Novo Nordisk today announced the completion of paradigm(TM) 2, the first phase 3 trial with a long-acting FIX derivative, N9-GP (glycopegylated recombinant factor IX), for haemophilia B patients. Paradigm(TM) 2 is a multi-centre, blinded trial evaluating the safety and efficacy of N9-GP when used for on-demand or prophylactic treatment in patients with haemophilia B.

In the trial, 74 patients were treated for six months on-demand, or 12 months by a prophylactic regimen of 40 U/kg or 10 U/kg N9-GP once weekly. The median bleeding rate for patients treated on-demand was 15.6 episodes per year. Patients on prophylaxis had a median annualised bleeding rate of 1.0 and 2.9 episodes per year, when treated with weekly doses of 40 U/kg and 10 U/kg, respectively.

Among patients randomised to receive 40 U/kg N9-GP, 99% of bleeding episodes were treated with only one infusion, and two-thirds of the patients experienced complete resolution of bleeding in their target joints. Patients in this dose group also reported animprovement in quality of life during the trial.

Pharmacokinetic data documented a steady state half-life of 110 hours.In the trial, N9-GP appeared to have a safe and well-tolerated profile.

No patients in the trial developed inhibitors, and no apparent differences between the treatment groups were observed with respect to adverse events and standard safety parameters.

“We are very excited about the strong results from this trial, which could represent a paradigm shift in the treatment of haemophilia B,” said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk. ”The trial demonstrated that once-weekly prophylactic administration of N9-GP can reduce the risk of bleeds by more than 90% compared to on-demand treatment and enable 99% of the few occurring bleeds to be stopped with a single dose.”

Novo Nordisk is expecting the two remaining phase 3 trials in the paradigm? programme involving paediatric patients and patients undergoing surgery respectively to be completed within the next 12 months. Regulatory submission of N9-GP in all major markets is expected in 2015 to enable validation of the commercial scale production.

About N9-GP and paradigm

N9-GP is a proprietary glycopegylated recombinant factor IX for patients with haemophilia B. Glycopegylation is a well-established protraction technology applied by Novo Nordisk on recombinant factor IX. The technology increases the circulating half-life of recombinant factor IX allowing for lower bleeding frequency with less frequent intravenous dosing.

The paradigm? programme is a Novo Nordisk registered trademark for trial conducted with N9-GP. The programme currently comprises seven clinical trials investigating pharmacokinetics, immunogenicity, efficacy and safety of N9-GP in adult and paediatric haemophilia B patients as well as in patients undergoing surgery.

 

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