Intarcia糖尿病药物ITCA650临床三期研究取得显著成果 - 药群论坛

ITCA650是一种植入皮下的微型真空泵，能够将GLP-1受体激动剂exenatide持续注入机体，进而达到降低糖尿病患者血糖水平的目的。在公司进行的第一项临床三期研究中，研究人员招募了约460名血糖水平在7.5%-10%之间的二型糖尿病患者，经过约39周的治疗后，数据显示相对于安慰剂组，接受ITCA650治疗的患者血糖被稳定控制在7%以下，达到了研究之初的首要终点设计。在另一项关于治疗血糖浓度在10%以上的患者的临床三期研究中，数据显示经过9个月的治疗，有25%的患者血糖浓度降低至7%以下。而这一结果也被认为是Intarcia公司取得的一项重大突破。

Intarcia公司在今年4月份获得了总额接近2亿美元的投资，同时公司CEO Kurt Graves表示公司暂时并不打算寻找共同开发ITCA的合作伙伴。

一直以来，糖尿病等重大慢性疾病的研发都充斥着各个医药巨头的身影，许多分析人士都认为小型生物医药公司很难有足够的创造力、财力和执行力来完成这些重大疾病药物的研发。显然Intarcia公司希望挑战这一铁律。目前糖尿病市场中，GLP-1药物正方兴未艾，其中尤以糖尿病药物巨头诺和诺德开发的GLP-1药物Victoza最为著名，但是这种药物需要每周甚至每天进行注射以保持患者血糖稳定在一定浓度。而ITCA的一大亮点就是一旦被植入，将在长达一年的时间里都起到稳定的降血糖效果。可以想见，一旦ITCA正式进入市场，必将在GLP-1药物市场乃至是糖尿病药物市场掀起巨浪。

Intarcia公司预计将于明年完成与默沙东公司糖尿病药物Januvia的对比研究，并最早将于2016年向有关部门提交上市申请。让我们拭目以待，且看Intarcia能否创造奇迹。

详细英文报道：

Well-funded biotech Intarcia Therapeutics is rolling along with its ambitious plans to develop a diabetes treatment without Big Pharma's help, posting positive results from two late-stage studies on its once-a-year drug-device combo.

Intarcia's product, ITCA 650, is an under-the-skin minipump armed with the GLP-1 receptor agonist exenatide--also known as AstraZeneca's ($AZN) Bydureon--for up to one year.

In its first Phase III trial, Intarcia enrolled 460 patients with Type 2 diabetes and blood glucose levels between 7.5% and 10%. After 39 weeks, ITCA 650 met its primary endpoint of significantly beating out placebo in reducing blood sugar and cleared secondary goals of weight loss and percentage of patients who reached their goal glucose levels of under 7%. In a second, open-label study on patients with blood glucose levels over 10%, ITCA got 25% of participants down below the 7% threshold and charted a sustained 3.4% reduction at 9 months.

Intarcia is calling that a major victory. Current GLP-1 therapies, led by Novo Nordisk's ($NVO) blockbuster Victoza, require daily or weekly injections to get diabetes down to their target blood sugar concentrations. If ITCA 650 can match its rivals on efficacy, its promise of a once-a-year procedure could disrupt the still-growing GLP-1 market.

The new clinical data spell a huge milestone for Intarcia, which closed a $200 million funding round in April and has steadfastly refused to seek a partner for its top prospect. Now, according to CEO Kurt Graves, that commitment is looking prudent.

"Many thought an emerging biotech company could never innovate enough, finance enough or execute well enough to bring a transformational therapy through Phase III in a major disease area like Type 2 diabetes," Graves said in a statement. "But we've proven it can be done, and done well."

But the company still has plenty of work to do. Intarcia is in the midst of a third Phase III trial, in which it has enrolled 500 patients to compare ITCA 650 to Merck's ($MRK) top-selling Januvia, a drug that lowers blood glucose by blocking a protein called DPP-4. That study is on track to wrap up in the summer, and, if all goes according to plan, Intarcia expects to submit its product for FDA review in 2016.