摘要: 生物技术公司Achillion最近正在紧锣密鼓地进行其治疗丙肝鸡尾酒疗法ACH-3102的开发。公司最近宣布目前ACH-3102与吉利德公司的Sovaldi联合治疗二期研究数据十分理想。此次二期研究受试的18名患者在接受鸡尾酒疗法之后 ...
生物技术公司Achillion最近正在紧锣密鼓地进行其治疗丙肝鸡尾酒疗法ACH-3102的开发。公司最近宣布目前ACH-3102与吉利德公司的Sovaldi联合治疗二期研究数据十分理想。此次二期研究受试的18名患者在接受鸡尾酒疗法之后全部痊愈且并未观察到明显副作用。下一步研究人员计划扩大二期临床研究规模,对照组与治疗组分别额外招募6名患者,并希望于今年年底正式完成这一临床研究。 此次研究的目的在于确定Achillion公司开发的NS5A抗丙肝药物ACH-3102与吉利德公司的Sovaldi在不使用利巴韦林联合治疗I型基因型丙肝患者的效果。尽管目前市场上吉利德与艾伯维等公司凭借自己的特效药已经占据丙肝治疗的半壁江山,但是Achillion公司仍有机会,此前Achillion就宣称希望将丙肝治愈周期缩短为8周。 此次临床二期研究公布刺激Achillion公司股价大涨,投资者希望这一数据将有助于大型生物医药公司收购这一疗法。 Biotech Achillion Pharmaceuticals ($ACHN) is working to get its name on the short list of blockbuster hepatitis Ccontenders, revealing promising Phase II data for a combination of its antiviral with Gilead Sciences' ($GILD) leading Sovaldi. In an 18-patient study, ACH-3102 and Sovaldi posted 100% cure rates for the 12 subjects receiving treatment, and the cocktail was well-tolerated with no significant adverse reactions, the company said. Now Achillion plans to expand the trial, moving the 6 observational patients into the treatment arm and enrolling 6 more, expecting to report full Phase II data by the end of the year. The trial's principal goal is to see how well ACH-3102, an NS5A inhibitor, can pair up with Sovaldi and cure treatment-naive patients with genotype 1 hep C without the use of ribavirin. The mid-stage results sent Achillion's shares up about 18% in premarket trading on Friday, stoking investors' hopes that the well-traveled biotech might attract a lucrative buyout offer now that hep C has become a cause célèbre among global drugmakers. Leaders in the hep C space already have combo therapies of their own, including Gilead and AbbVie ($ABBV), which each expect an FDA approval this year. But the bull case for Achillion lies in the breadth of the market. Earlier this summer, Merck ($MRK) signed on to pay about $3.9 billion for Idenix Pharmaceuticals and expand its number of shots on the hep C goal, and Achillion could potentially fill that role for a deep-pocketed drugmaker looking to cut the line. And the biotech's pipeline isn't limited to an NS5A blocker. Sovaprevir, the company's Phase II NS3/4A protease inhibitor, came off clinical hold in June, and the treatment has the agency's fast-track designation. Furthermore, Achillion has high hopes for ACH-3422, an in-house nucleotide that could co-star in a future combo therapy with ACH-3102, CEO Milind Deshpande said. "As we continue to achieve clinical milestones, we remain focused on execution of the broader clinical development strategy for our HCV portfolio," Deshpande said in a statement. "We expect that Phase I proof-of-concept results with ACH-3422 will be reported during the fall of this year, which we anticipate will lead to the start of a Phase II combination program to evaluate our proprietary doublet regimen for an 8-week, or potentially shorter, treatment regimen for HCV that will begin before the end of 2014."
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