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Lexicon糖尿病药物LX4211二期临床研究完成

  1. Lexicon
  2. LX4211
  3. SGLT12
  4. 一型糖尿病

来源:生物谷 2014-04-22 10:30

Lexicon糖尿病药物LX4211二期临床研究顺利完成

2014年4月16日讯 /生物谷BIOON/ --刚刚经历裁员风波的美国德克萨斯州生物技术公司Lexicon公司最近终于迎来了一项利好消息。公司宣布其研发的一项SGLT1/2抑制物类糖尿病药物LX4211临床二期研究结果表现良好。公司将可以据此准备后期研究。研究数据显示,在治疗一型糖尿病的临床试验中服用新药的患者改善率达到了32%,而对照组数字仅为6%。在良好控制血糖水平的基础上,另一项指标HbAc降低水平达到了0.55%,对照组则仅降低了0.06%。这也使得LX4211进一步开发的计划引起市场的注意,一些评论人士认为Lexicon公司需要找到一个强有力的合作伙伴以保证研究过程的顺利进行,但也有人认为Lexicon可以独立进行一型糖尿病的研究,而关于二型糖尿病的进一步研究应当放在以后进行。不过不论如何,LX4211二期研究的顺利完成也使公司在目前糖尿病市场的激烈竞争中拥有了一张底牌。近年来礼来、赛诺菲和强生等生物医药巨头都在这一领域投入巨资希望占据有利位置。(生物谷Bioon.com)

详细英文报道:

The newly downsized Texas-based Lexicon Pharmaceuticals says it nailed promising data on its experimental diabetes drug, positioning it for a late-stage study that could leave it poised to compete with a full lineup of rival treatments already brought to the market by a group of pharma giants.

Back in January Lexicon ($LXRX) axed close to half of its staff, laying off 115 as the biotech circled its wagons around an SGLT1/2 inhibitor. On Monday the biotech reported that the drug scored a success in Phase II, reducing the amount of insulin Type 1 diabetes patients were taking by 32% compared to a reduction of only 6% in the placebo arm.

Investigators for the company added that the drug significantly improved "glycemic control with a mean HbA1c reduction of 0.55% in the LX4211-treated group compared to a reduction of only 0.06% with placebo."

The company's stock spiked on the success.

The results also set off a discussion about the company's prospects for Phase III. Some analysts believe that Lexicon will have to sign up a major league partner if it hopes to get through late-stage development, which can easily cost hundreds of millions of dollars. Others have expressed the opinion that Lexicon can get through a Phase III study on the smaller Type 1 market on its own, leaving the mass Type 2 market for a later day.

Diabetes is the kind of mass market that leaves regulators on high alert for any potential safety issues. As a result, any company looking to get a drug approved has to clear a very high bar, leaving this field dominated by giants like Sanofi ($SNY), Eli Lilly ($LLY), Johnson & Johnson's ($JNJ) and others carving up blockbuster markets.

SGLT2 in particular has proven a tempting--but tough--target. The FDA recently rejected empagliflozin, which still represents Lilly's best shot at competing with SGLT2 pioneers like J&J's Invokana and Farxiga (dapagliflozin) from AstraZeneca ($AZN) and Bristol-Myers Squibb ($BMY), which was finally approved by the FDA in January after a long delay. Lilly presented the FDA with data from 10 multinational clinical trials and more than 13,000 people with Type 2 diabetes for its drug but was stiff-armed on an approval until its partner, Boehringer Ingelheim, resolves an FDA challenge on its manufacturing site.

CEO Arthur Sands, though, is staying upbeat about the challenge.

"The results from this study provide a clear demonstration of proof-of-concept of LX4211 as an oral, investigational new drug for type 1 diabetes complementing insulin therapy," said Sands in a prepared statement. "The magnitude of improved glycemic control by several measures, including HbA1c in only four weeks, and lower insulin requirements are highly encouraging and support the progression of LX4211 into late-stage development for type 1 diabetes."

 

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