Revance新一代肉毒素美容药物RT001未能进入临床三期研究

Revance新一代肉毒素美容药物RT001未能进入临床三期研究

                               
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发布日期：2014-11-15  来源：生物谷   
5 o2 b1 l1 A  j( t+ i% u6 A* l7 _  ~5 w Revance Terapeutics生物医药公司最近宣布，被公司寄予厚望的药物RT001研发流程未能进入临床后期研究。

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这一消息也引起了公司股价的下挫。Revance医药公司将RT001看做是肉毒素药物的最佳后续者。在公司最近举行的季度财报上，公司透露RT001治疗眼角鱼尾纹的研究目前等待先行试验的结果。公司管理人员表示，研究人员仍需要一些进一步的研究结果来评估这种药物。公司CEO Dan Browne表示研究人员对这一药物的疗效表示满意，但是目前的研究数据并不足以支撑这种药物正式进入临床三期研究。他还预计关于RT001的临床三期研究计划将于2015年正式启动。
: b- D" Y/ ]* a% b# h% C5 X6 v8 T这一消息不禁引起了投资者的担忧，这一忧虑也体现在了公司股价上。去年，Revance公司为RT001的研发进行IPO，曾一度引起投资市场的追捧。
$ C8 F! p0 ^! b+ E据统计，目前美国皮肤美容市场份额达到了14亿美元之多。Revance公司曾估计一旦RT001上市，将会给这一市场带来巨大冲击，从而使得公司在这一领域占据优势。
RT001是一种注射用美容药物，它被Revance公司认为是目前美容市场上流行的肉毒素类药物的最好替代者。爱美女性对肉毒素这种药物一定不会陌生。这种药物自从上世纪末上市后，因其明显的祛皱效果和无需手术的治疗手段迅速在美容市场中引起了巨大轰动。BOTOX药物可以阻断神经与肌肉的神经冲动，麻痹过于发达的肌肉，使之收缩。，它是利用麻痹肌肉来达到失能性的萎缩的目的，使原本肥厚增生的肌肉缩小。
详细英文报道
4 |9 W) F9 {$ ~3 J1 K! S3 e8 g7 ZRevance Therapeutics' ($RVNC) top prospect, a topical successor to Botox, has fallen off schedule, putting off the company's Phase III plans until next year and sending its shares southward.
In its quarterly earnings statement, Revance disclosed that RT001 isn't yet ready to enter late-stage development as a treatment for crow's feet, yet another delay for a drug once expected to wrap up Phase III this year. RT001 is currently in an open-label study, and, looking at preliminary results, Revance has concluded that "we still have some work to do to optimize the transfer of manufacturing to our commercial facility and increase the probability of success for our upcoming Phase III pivotal program," CEO Dan Browne said in a statement.
) H6 H1 |: c' Y. I& m, r"We are encouraged by the valuable and promising efficacy data observed among the patient and physician measurements, but the preliminary composite results were not adequate to move forward with our Phase III pivotal study at this time," Browne said. "As a next step, we plan to complete the ongoing open-label study, fully analyze the data and manufacture additional RT001 drug product in our commercial facility to support a subsequent study expected to commence in early 2015."
The setback sent Revance's shares down more than 30% on Thursday morning, as investors are growing all the more skeptical of the company's plans to unseat injectable treatments like Botox with a topical solution. In its IPO pitch last year, Revance touted RT001 as poised to disrupt the $1.4 billion aesthetic dermatology market for such drugs, planning to launch it with a small sales force.
" M) X: r$ _% d, i" FThose ambitions are now on hold, but Revance is staying optimistic about its pipeline potential. Beyond the crow's feet indication, RT001 is slated to enter a Phase II trial in excessive sweating next year, the company said, and the injectable RT002 is on course to begin mid-stage study in frown lines by year's end.
& J  [5 Y2 T) g7 z9 G8 j& QThe promise of that pipeline helped Revance pull off a $96 million IPO in the first quarter, part of a record-setting deluge of biotech debuts that saw nearly 30 companies bring in more than $2 billion.
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