Study VEL-2002 further validates solabegron’s potential for best-in-class efficacy across multiple primary and secondary endpoints
Wayne, PA ——Velicept疗法, a privately-held specialty pharmaceutical company dedicated to the development of best-in-class compounds for the treatment of urological and gastrointestinal disorders, announced that its next generation beta-3 adrenoceptor agonist solabegron met the primary endpoint in VEL-2002, 膀胱过动症(OAB)患者的2b期研究. In the study, twice-daily administration of solabegron demonstrated a statistically significant improvement compared to placebo at week 12, 用每天排尿次数的平均变化量来衡量, 研究的主要终点. Solabegron also demonstrated statistical significance across multiple secondary endpoints including percent reduction of urge urinary incontinence episodes, dry rate, 紧急事件.
这项为期12周的安慰剂对照的VEL-2002研究招募了435名年龄在18至80岁之间患有OAB的女性. Solabegron总体耐受良好. Treatment emergent adverse events and serious adverse events were infrequent and comparable between the solabegron and placebo-treated groups. Velicept plans to submit the data from the VEL-2002 study for presentation at upcoming scientific meetings.
“We are encouraged by these positive top-line results for VEL-2002 as they are consistent with what we’ve seen in a prior study with solabegron undertaken by GSK and further validate the potential for best-in-class efficacy and improved safety for patients with OAB,詹姆斯·沃克说, Velicept疗法的总裁兼首席执行官. “我们期待着第二项研究的结果, 这将帮助我们最终确定明年初推进关键的第三阶段项目的计划.”
Velicept还开发了一种小说, solabegron每日一次配方，正在进行2b期研究(VEL-2001)中进行评估。. VEL-2001 has completed enrollment and the company expects to announce top-line results in the second quarter of this year.
Solabegron is a highly potent and selective beta-3 adrenoceptor agonist being investigated for overactive bladder (OAB) and irritable bowel syndrome (IBS). solabegron在OAB中的2期研究, 之前由葛兰素史克公司进行, evaluated a twice-daily dose in 258 patients with moderate to severe incontinence experiencing an average of 4.每天5集湿. 结果显示，与安慰剂相比，solabegron有统计学上显著的改善. Furthermore, the Phase 2 study also indicated a safety and tolerability profile for solabegron that was similar to placebo.
Velicept疗法公司. 是私有的吗, clinical development company focused on advancing best-in-class compounds for the treatment of urological and gastrointestinal disorders. 它的主导产品, solabegron, is a highly potent and selective beta-3 adrenoceptor agonist being investigated for overactive bladder (OAB) and irritable bowel syndrome (IBS). 欲了解更多信息，请访问 www.velicept.com.