Lee Chih-Hung, Ou Chien-Chih, Chen Tim-Mo
Department of Dermatology, Kaohsiung Chang Gung Memorial Hospital, and Chang Gung University College of Medicine, Kaohsiung, 833, Taiwan, ROC.
Department of Development Team, OBI Pharma, Taipei, 115, Taiwan, ROC.
Dermatol Ther (Heidelb). 2024 Dec;14(12):3367-3378. doi: 10.1007/s13555-024-01309-7. Epub 2024 Nov 25.
OBI-858 is a brand-new botulinum Type A complex toxin with a specific molecular weight of 760 kDa intended for development for both aesthetic and therapeutic applications. This is a phase I, dose-escalation study to evaluate the safety and preliminary efficacy of OBI-858 in subjects with moderate to severe glabellar lines.
Each subject received OBI-858 by intramuscular injections with an assigned dose (10 U, 20 U, and 30 U). The safety and preliminary efficacy were evaluated at each of the in-person visits.
A total of 36 subjects (12 subjects per cohort) were enrolled. The response rates (≥ 1 point) for all groups at maximum frown were assessed at week 4 were 100%. The initial improvement for 30 U occurred at day 3. Response rates revealed benefits lasting 4-6 months or longer. Subject satisfaction at week 4 was high in all groups. Adverse effects were mild and infrequent. Among them, one subject had drug-related AE, and one subject had grade ≥ 3 unrelated AE.
This study demonstrated that OBI-858 is well tolerated and showed preliminary efficacy. Overall, the OBI-858 has a clinically favorable profile of safety and efficacy that warrants proceeding to the next studies.
OBI-858是一种全新的A型肉毒杆菌复合毒素，其特定分子量为760 kDa，旨在用于美容和治疗应用的开发。这是一项I期剂量递增研究，旨在评估OBI-858在中度至重度眉间纹受试者中的安全性和初步疗效。
每位受试者通过肌肉注射接受指定剂量（10 U、20 U和30 U）的OBI-858。在每次亲自就诊时评估安全性和初步疗效。
共招募了36名受试者（每组12名受试者）。在第4周评估所有组在最大皱眉时的反应率（≥1分）为100%。30 U剂量组在第3天出现初始改善。反应率显示益处持续4至6个月或更长时间。所有组在第4周时受试者满意度都很高。不良反应轻微且不常见。其中，一名受试者出现与药物相关的不良事件，一名受试者出现≥3级的非相关不良事件。
本研究表明OBI-858耐受性良好，并显示出初步疗效。总体而言，OBI-858具有临床上良好的安全性和疗效特征，值得进行后续研究。
