Healis Therapeutics' asset CKDB-501A shares Phase III topline results for glabellar injections from CKD Bio in South Korea
February 27 2024 - 8:00AM
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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