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WOBURN, Mass., Oct. 1, 2024. Eirion Therapeutics Inc., a biopharmaceutical company focused on developing innovative aesthetic prescription product offerings, announced today that successful results had been achieved in its Phase 1 - 2 clinical trial for the treatment of moderate to severe glabellar wrinkles using its next generation, ready-to-use liquid injectable neuromodulator AI-09.
马萨诸塞州沃本,2024年10月1日。专注于开发创新美学处方产品的生物制药公司Eirion Therapeutics Inc.今天宣布,其使用下一代即用型液体注射神经调节剂AI-09治疗中度至重度眉间皱纹的1-2期临床试验取得了成功结果。
The double-blind, placebo-controlled, dose escalation study studying 96 subjects at four U.S. investigational sites found AI-09 to be safe and well tolerated. The study found that a dose-response pattern was evident both in terms of efficacy and duration of response. The higher doses tested demonstrated clinically and statistically significant efficacy results.
这项双盲、安慰剂对照、剂量递增研究对美国四个研究地点的96名受试者进行了研究,发现AI-09安全且耐受性良好。该研究发现,剂量反应模式在疗效和反应持续时间方面都很明显。测试的较高剂量显示出临床和统计学上显着的功效结果。
The median duration of response for the highest dose tested was 26 weeks or 6 months. Duration of response was based on maintaining a ≥1 point improvement from baseline on the 4-point scale used by the investigators to assess wrinkle severity.'AI-09 first-in-human clinical trial achieved all study objectives for safety, efficacy and duration', said Leslie Baumann, MD, a leading clinical investigator in the field of aesthetic neuromodulators and the principal investigator in the study.
测试的最高剂量的中位反应持续时间为26周或6个月。反应的持续时间是基于在研究人员用于评估皱纹严重程度的4分量表上,从基线保持≥1分的改善。”AI-09首次人体临床试验实现了安全性,有效性和持续时间的所有研究目标”,Leslie Baumann医学博士说,Leslie Baumann是美学神经调节剂领域的领先临床研究者,也是该研究的主要研究者。
'A ready-to-use, liquid neuromodulator formulation that lasts 6 months will appeal to both physicians and patients. I look forward to further development work on this promising product candidate.'Eirion also announced completion of a survey of over 800 U.S. residents assessing the importance of duration of response.
“一种持续6个月的即用液体神经调节剂配方将吸引医生和患者。我期待着对这一有前途的候选产品进行进一步的开发工作。”埃利昂还宣布完成对800多名美国居民的调查,评估回应持续时间的重要性。
Survey respondents all had been treated in the past with a neuromodulator for their glabellar wrinkles ('frown lines'). The survey was comprised of approximately half women and half men. When asked if a botulinum treatment for frown lines .
调查对象过去都曾接受过神经调节剂治疗他们的眉间皱纹(“皱眉线”)。该调查由大约一半的女性和一半的男性组成。当被问及是否用肉毒杆菌治疗皱纹时。