Healis Therapeutics Announces Supply Agreement with CKD Bio to develop CKDB-501 for neuropsychiatric indications

NEWPORT BEACH, Calif., Jan. 02, 2024 (GLOBE NEWSWIRE) -- Healis Therapeutics, a privately held biotechnology company, today announced it has entered into a supply agreement with CKD Bio Corporation (A063160.KS) for CKDB-501, a neuromodulator BoNT/A protein. CKD Bio is a subsidiary of Chong Kun Dang group based in Seoul, South Korea.

Healis Therapeutics intends to develop CKDB-501 for Major Depressive Disorder (MDD) and Post-Traumatic Stress Disorder (PTSD). Healis plans to enter clinical trials in the U.S. and other countries. “We are excited to work with CKD Bio, a global leader in biologics, on a collaboration to develop CKDB-501 for MDD and PTSD” said Dr. Eric Finzi, Co-Founder of Healis, who started the field of BoNT/A for depression research.

Worldwide, approximately 280 million patients experience Major Depressive Disorder (MDD) annually, according to the World Health Organization (WHO). In the U.S. alone, 22 million patients suffer from MDD and 20 million from PTSD, annually, according to data collected by the National Institutes of Mental Health and Department of Veterans Affairs.

“Our collaboration with CKD Bio on this new agreement could one day impact over 42 million Americans” said Sebastian De Beurs, Co-Founder of Healis. “This planned clinical development represents the largest patient population and market opportunity of any therapeutic indication in the history of BoNT/A,” De Beurs said.

Ten randomized controlled trials conducted in 5 countries to date have shown promising early results on glabellar Botulinum Toxin Type A (BoNT/A) treatments for Major Depressive Disorder (MDD). “We hope this partnership will accelerate the development of BoNT/A as a potential on-label treatment available to millions of MDD and PTSD patients worldwide” said Dr. Finzi.

About Healis
Healis 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

About CKDB-501
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 Note Regarding Forward-Looking Statements
Healis cautions you that some statements contained in this press release regarding matters that are not historical facts are forward-looking statements. The forward-looking statements are based on our current beliefs and expectations and include, but are not limited to: our expectations regarding the potential therapeutic benefits of our product candidates, our beliefs regarding market sizes and opportunities; and the planned advancement of our development pipeline, including the clinical development plans, and our ability to realize the benefits described in this press release. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in our business and scientific approach. As of 21 December 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.

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Healis Therapeutics, Inc