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.

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). 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. 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.

Healis plans to study CKDB-501A for therapeutic indications in the U.S. and E.U., including for neuropsychiatry. “Healis’ clinical program in BoNT/A for neuropsychiatry alone has the potential to transform care for what the World Health Organization (WHO) estimates at 280 million patients suffering from Major Depressive Disorder (MDD) globally,” said Sebastian De Beurs, Co-Founder of Healis.

Healis Therapeutics announced a strategic partnership with CKD Bio in 2024 to develop CKDB-501A for CNS indications. “We are grateful to be at the forefront of innovation, bringing a novel BoNT/A to the world that is both safe and efficacious for cosmetic and therapeutic uses,” said CKD Bio’s executive leadership.

About Healis Healis Therapeutics is a neuroscience company advancing the treatment of neuropsychiatric and neurodegenerative diseases. For more information about Healis Therapeutics, please visit our website at www.healisthera.com

About CKDB-501A CKDB-501 is a neuromodulator Serotype A botulinum toxin (BoNT/A) protein in development by CKD Bio Corp. CKD Bio Corp is listed on the Korea Stock Exchange (A063160.KS).

Cautionary NoteAs of 26 February 2023, BoNT/A is not an FDA approved drug for the treatment of MDD and PTSD. BoNT/A for MDD and PTSD is under investigational use only and not available for commercial distribution.

Media Contact Healis Therapeutics, Inc info@healisthera.com

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