总部位于麻省坎布里奇的生物技术公司Zafgen公司最近传出消息，希望进行IPO募集约8600万美元资金用于其创新减肥药beloranib的中后期临床研究。此前Zafgen公司的减肥药beloranib在中期研究中取得了令人惊讶的效果。与以往减肥药抑制服用者食欲的原理不同，beloranib主要是通过抑制人体中负责合成脂肪的关键酶me-taP2的活性以达到减肥效果的。在去年进行的关于beloranib的临床二期研究显示，患者服用药物12周平均减重达22磅左右。同时服用这种药物的肥胖症患者的副作用相较于传统减肥药也更加轻微。
这也表明beloranib在减肥药市场的强大潜力。在Zafgen的招股说明书中，Zafgen公司表示公司将会寻求先在一些特殊体质患者群体中应用beloranib，以获得FDA小范围的准入批准，然后再进行更大规模的临床实验为最终登陆减肥药物市场做准备。
Zafgen has been turning heads with some jaw-dropping results from its mid-stage studies for a promising new obesity drug. And now the biotech hopes to parlay its eye-catching, if risky, technology into an $86 million IPO.
Just ab0ut all of Zafgen's eggs rest in a single nest for beloranib, blocking the methionine aminopeptidase 2, or me-taP2, enzyme--which plays a role in the body's production and use of fatty acids. The drug knocks off weight by dialing down the amount of fat produced by the body, a completely different approach from the current crop of drugs, which is designed to suppress appetite.
Late last year the Cambridge, MA-based biotech posted a stellar Phase II study of beloranib that tracked rapid weight loss among the severely obese, with one group shedding an average of 22 pounds in 12 weeks. The big idea here is that Zafgen's drug could replac a pricey medical procedure to spur weight loss, helping patients avoid a multitude of ailments that can be spurred by obesity. And it could prove to be a whole new standard of care compared to the current crop of obesity drugs on the market--provided it survives a gamut of clinical trials.
Zafgen noted in its S-1 filing with the SEC that the company plans to pursue small subpopulations of patients with rare conditions for its first approvals. As it's setting up targeted approvals, the biotech can position itself for a regulatory OK for obesity - a mass market that will require a huge and costly late-stage program with thousands of patients and a clear record on safety.
ab0ut a year ago Zafgen, a Fierce 15 biotech, was the subject of considerable buzz ab0ut a potential buyout. But the deal evidently never made it past the discussion phase. Zafgen banked a $45 million Series E round in December, adding a group of new investors to its fan club that includes RA Capital Management, Brookside Capital, Venrock, Alta Partners, an undisclosed "blue chip" investor and a private investor.
The company plans to list on Nasdaq under the $ZFGN symbol. Zafgen has burned through ab0ut $69 million since it was founded in 2005, operating as a lean-and-mean virtual biotech with only a handful of staffers working with CEO Tom Hughes. Its board includes Atlas Venture's Bruce Booth, Lou Tartaglia from Third Rock and John LaMattina, the former global chief of Pfizer R&D. Atlas and Third Rock each own a big chunk of the biotech's stock.
Zafgen has one other drug on the radar: ZGN-839, a preclinical therapy for nonalcoholic steatohepatitis, or NASH, nonalcoholic fatty liver disease, abdominal obesity and type 2 diabetes.
免责声明：
本文仅供专业人士学术交流探讨，不作为诊疗及用药依据。
如有侵权，请联系我们删除