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诺和诺德N8-GP首个III期研究获积极数据

来源:生物谷 2014-03-20 07:20

2014年3月20日讯 /生物谷BIOON/ --诺和诺德(Novo Nordisk)3月19日宣布,长效重组因子VIII产品N8-GP(turoctocog alfa pegol)Pathfinder项目首个III期试验Pathfinder-2已经完成。Pathfinder-2是一项多中心试验,评价了N8-GP用于12岁及以上A型血友病患者预防性(prophylactic)治疗和按需(on-demand)治疗的安全性和疗效。

研究中,175例患者每4天接受一次50U/kg预防性治疗方案,11例患者在出血事件发生时接受按需治疗方案,治疗持续长达21个月。数据表明,预防性治疗组和按需治疗组年化平均出血发生率分别为1.3%和30.9%。药代动力学数据表明,N8-GP单剂量半衰期为18.4小时,预防性治疗组接受下一个剂量前即时测定的药物平均谷低浓度(trough level)为8%。研究中,N8-GP具有良好的安全性和耐受性,仅有1例患者产生FVIII抑制剂,这与以往已接受治疗的A型血友病群体中的预期一致。

这些数据表明,N8-GP有望减少静脉注射的次数,减轻患者的治疗负担,并取得了强劲的疗效和安全性数据。

诺和诺德预计,Pathfinder项目中剩下的3个III期临床试验,将于未来12个月完成。这些研究分别调查了N8-GP用于治疗儿科患者、用于外科手术及作为每周一次的预防性治疗药物。

关于N8-GP

N8-GP是一种糖基聚乙二醇化形式的重组凝血因子VIII产品NovoEight(turoctocog alpha),开发用于A型血友病患者的治疗。糖基聚乙二醇化技术能够增加重组凝血因子VIII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。

NovoEight是诺德诺德第三代重组凝血因子VIII产品turoctocog alpha的商品名,于2013年获FDA和欧盟批准,用于A型血友病患者的预防性治疗和按需治疗,该产品利用了最新的基因重组及蛋白纯化技术。(生物谷Bioon.com)

英文原文:Novo Nordisk reports positive results from first phase 3 trial with N8-GP, a long-acting factor VIII for treatment of haemophilia A

Bagsværd, Denmark, 19 March 2014 - Novo Nordisk today announced the completion of pathfinder(TM)2, the first phase 3 trial with long-acting recombinant factor VIII, N8-GP (turoctocog alfa pegol) for haemophilia A patients. Pathfinder(TM)2 is a multi-national trial evaluating safety and efficacy of N8-GP, when administered for prophylaxis and on-demand treatment  in patients with haemophilia A, who are 12 years or older.

In the trial, 175 patients were treated with a prophylactic regimen of 50 U/kg every fourth day and 11 patients received on-demand treatment, when bleedings occurred. Patients were treated for up to 21 months, resulting in median annualised bleeding rates of 1.3 and 30.9 episodes for patients treated prophylactically and on-demand, respectively.

The pharmacokinetic data documented a single dose half-life of 18.4 hours and a mean trough level of 8% measured immediately before next dose for patients on prophylaxis treatment.

N8-GP appeared to have a safe profile and to be well tolerated. Among the 186 patients in the trial, one patient who responded well to prophylactic treatment throughout the trial developed an FVIII inhibitor. This is in line with expectations in a population of previously treated haemophilia A patients.

"We are very pleased with the results of pathfinderT2. These results show that N8-GP has the potential to reduce the burden of treatment by decreasing the number of intravenous infusions while achieving strong results in terms of efficacy and safety for people with haemophilia A", said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk.

Novo Nordisk is expecting the three remaining trials in the pathfinderT programme to be finalised within the next 12 months. These trials investigate N8-GP as a treatment for paediatric patients, surgical procedures and as once-weekly prophylactic treatment.

About N8-GP and pathfinderT
N8-GP (turoctocog alfa pegol) is a glycopegylated form of turoctocog alfa designed for prolonged half-life. The modification that renders N8-GP long-acting is located in the B-domain whereby the active factor VIII generated by thrombin activation is identical to endogenous FVIII and to activated turoctocog alfa.

PathfinderT is a Novo Nordisk registered trademark for trials conducted with N8-GP. The programme includes more than 200 patients with haemophilia A investigating pharmacokinetics, safety and efficacy of N8-GP in adults and children as well as patients undergoing surgery.

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