NEWPORT BEACH, Calif., Feb. 27, 2024 (GLOBE NEWSWIRE) -- Healis Therapeutics, a privately held biotechnology company, is thrilled to share that strategic partner, Chong Kun Dang Bio (063160:Korea SE), has released topline results from Phase III on Healis’ lead compound, CKDB-501A. The study results demonstrated that CKDB-501A is non-inferior compared to the active-controlled BOTOX® by AbbVie (NYSE: ABBV) in improving moderate-to-severe glabellar lines.

加利福尼亚州纽波特海滩，2024年2月27日（环球通讯社）--Healis Therapeutics是一家私营生物技术公司，很高兴与大家分享战略合作伙伴Chong Kun Dang Bio（063160:Korea SE）发布了Healis先导化合物CKDB-501A第三阶段的topline结果。研究结果表明，CKDB-501A在改善中度至重度眉间线方面，与AbbVie（NYSE:ABBV）的主动控制型BOTOX®相比并不差。

CKDB-501A is a novel BoNT/A neuromodulator protein developed by CKD Bio. A randomized, double-blind, active-controlled, multi-center Phase 3 trial to investigate the efficacy and safety of CKDB-501A in subjects with moderate-to-severe glabellar lines was completed in South Korea on November 20, 2023 (NCT05804656).

CKDB-501A是由CKD Bio开发的一种新型BoNT/a神经调节剂蛋白。一项随机，双盲，主动对照，多中心的3期临床试验于2023年11月20日在韩国完成，该试验旨在研究CKDB-501A对中度至重度青光眼患者的疗效和安全性（NCT05804656）。

A total of 307 subjects participated and screened in the study. Among them, 300 subjects were randomized. “This is clinically promising to see Healis’ lead protein, CKDB-501A, pass safety and efficacy in South Korea,” said Dr. Eric Finzi, Co-Founder of Healis Therapeutics. “These results from South Korea bring us one step closer to bringing a novel BoNT/A developed for neuropsychiatry to the United States and Europe.” Glabellar BoNT/A injections have shown clinical promise in treating neuropsychiatric disorders via amygdala downregulation.

共有307名受试者参与并筛选了这项研究。其中，300名受试者被随机分配。Healis Therapeutics联合创始人Eric Finzi博士说：“临床上有望看到Healis的先导蛋白CKDB-501A在韩国通过安全性和有效性。”。“来自韩国的这些结果使我们更接近于将一种用于神经精神病学的新型BoNT/a引入美国和欧洲。”小脑BoNT/a注射已显示出通过杏仁核下调治疗神经精神疾病的临床前景。

Neural activity in the amygdala has been linked to facial feedback in glabella. Determining the safety and efficacy of CKDB-501A in treating the glabella is the first step towards unlocking the clinical promise of BoNT/A in planned Phase II trials for Major Depressive Disorder (MDD), Post-Traumatic Stress Disorder (PTSD), and other CNS indications.

杏仁核的神经活动与小脑的面部反馈有关。确定CKDB-501A治疗小脑的安全性和有效性是在计划的重度抑郁症（MDD），创伤后应激障碍（PTSD）和其他中枢神经系统适应症的II期试验中解锁BoNT/A临床前景的第一步。

Healis plans to study CKDB-501A for therapeutic indications in the U.S. and E.U., including for neuropsychiatry. “Healis’ clinic.

Healis计划在美国和欧盟研究CKDB-501A的治疗适应症，包括神经精神病学。“希利斯诊所。