Phase I Trial to Assess the Safety, Tolerability, and Preliminary Efficacy of OBI-858 for Treatment of Glabellar Lines.

IF 3.5 3区医学 Q1 DERMATOLOGY Dermatology and Therapy Pub Date : 2024-11-25 DOI:10.1007/s13555-024-01309-7

Chih-Hung Lee, Chien-Chih Ou, Tim-Mo Chen

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Abstract

Introduction: 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.

Methods: 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.

Results: 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.

Conclusions: 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.

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评估 OBI-858 治疗眼睑纹的安全性、耐受性和初步疗效的 I 期试验。

简介OBI-858是一种全新的A型肉毒杆菌复合毒素，分子量为760 kDa，用于美容和治疗。这是一项 I 期剂量递增研究，旨在评估 OBI-858 对中度至重度眉间纹患者的安全性和初步疗效：方法：每名受试者以指定剂量（10 U、20 U 和 30 U）肌肉注射 OBI-858。结果：总共有 36 名受试者（12 名受试者）接受了 OBI-858 的注射：结果：共招募了 36 名受试者（每组 12 名）。在第 4 周进行的最大皱纹评估中，各组的反应率（≥ 1 分）均为 100%。30 U 的初步改善发生在第 3 天。反应率显示，疗效可持续 4-6 个月或更长时间。所有组别在第 4 周时的受试者满意度都很高。不良反应轻微且不常见。其中，1名受试者出现药物相关不良反应，1名受试者出现≥3级的非相关不良反应：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 的安全性和有效性在临床上表现良好，值得进行下一步研究。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Dermatology and Therapy Medicine-Dermatology

CiteScore

6.00

自引率

8.80%

发文量

187

审稿时长

6 weeks

期刊介绍： Dermatology and Therapy is an international, open access, peer-reviewed, rapid publication journal (peer review in 2 weeks, published 3–4 weeks from acceptance). The journal is dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of dermatological therapies. Studies relating to diagnosis, pharmacoeconomics, public health and epidemiology, quality of life, and patient care, management, and education are also encouraged. Areas of focus include, but are not limited to all clinical aspects of dermatology, such as skin pharmacology; skin development and aging; prevention, diagnosis, and management of skin disorders and melanomas; research into dermal structures and pathology; and all areas of aesthetic dermatology, including skin maintenance, dermatological surgery, and lasers. The journal is of interest to a broad audience of pharmaceutical and healthcare professionals and publishes original research, reviews, case reports/case series, trial protocols, and short communications. Dermatology and Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an International and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of quality research, which may be considered of insufficient interest by other journals. The journal appeals to a global audience and receives submissions from all over the world.