CKDB-501A

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. 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

NEWPORT BEACH, Calif., Feb. 12, 2024 (GLOBE NEWSWIRE) -- Healis Therapeutics is pleased to announce it has been competitively selected to present at several key investor conferences. At BIO-Neuroscience, held in Amsterdam, the Netherlands, Healis will be presenting on Wednesday February 14th. “It is an honor to return to my home country, the Netherlands, a pioneer in neuroscience, to present Healis Therapeutics, the leading biotech company in neuromodulation,” said Sebastian De Beurs, Co-Founder of Healis. Healis will also be present at the BIO CEO & Investor Conference held in New York, NY on February 26-27, and at the Global Life Science Partnering & Investor Conference in San Diego, CA on February 28-29. Healis Therapeutics’ clinical program developing BoNT/A neuromodulator proteins for neuropsychiatry alone has the potential to transform care for over 280 million patients worldwide with Major Depressive Disorder (MDD), among other indications. “We are excited to continue our dialogue with the world’s leading neuroscience investors and stakeholders” said Dr. Eric Finzi, who Co-Founded Healis Therapeutics. “Healis has made rapid progress over the last year and we are keen to share exciting clinical, commercial, and regulatory milestones with the biotech community” said Dr. Finzi. Healis’ selection for conferences comes shortly after a recent announcement of its commercial partnership with CKD Bio, based in South Korea, for therapeutic rights of CKDB-501, a novel BoNT/A neuromodulator protein. Healis intends to develop CKDB-501 for CNS conditions under the leadership of Dr. Eric Finzi, who pioneered the field of BoNT/A neuromodulation for neuropsychiatry. “Growing up as the son of two psychologists in Amsterdam, I never dreamed of returning to my hometown representing Healis, the leading biotech company in neuromodulation, at BIO-Neuroscience,” said De Beurs. “We hope one day to serve the over 280 million patients in need of better neurotherapeutics for depression.” About HealisHealis Therapeutics is a neurotherapeutics company advancing the treatment of neuropsychiatric and neurodegenerative disease. For more information about Healis Therapeutics, please visit our website at www.healisthera.com Media ContactHealis Therapeutics, Incinfo@healisthera.com