Healis Therapeutics LLC

NEWPORT BEACH, Calif., March 26, 2024 (GLOBE NEWSWIRE) -- Healis Therapeutics is pleased to announce that it has entered a clinical collaboration with Massachusetts General Hospital (MGH), a founding member of the Mass General Brigham health system, and affiliates of Harvard Medical School (HMS). The collaboration will focus on Healis’ upcoming clinical trial studying the safety and efficacy of CKDB-501A, a BoNT/A neuromodulator, for the treatment of neuropsychiatric conditions, including Major Depressive Disorder (MDD), PTSD, and Social Anxiety Disorder (SAD). One of Healis’ strategic priorities is developing the research of Dr. Eric Finzi, who first discovered the efficacy of BoNT/A neuromodulators for neuropsychiatric disorders. “We continue to observe very significant need in the neuropsychiatric patient population,” said Dr. Eric Finzi, Co-Founder of Healis Therapeutics. "We are thrilled to work with the world’s leading psychiatry researchers, bringing deep clinical expertise to Healis Therapeutics’ upcoming trial.”Healis Therapeutics’ 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. “MDD remains a public health challenge around the world,” said Erik Van Widenfelt, Head of Clinical Trials at Healis Therapeutics. Erik previously worked with Harvard T Chan School of Public Health and alongside major biopharma companies Merck, Roche, Bristol Myers Squibb, Glaxo-Smith Klein, and others. “We are thrilled to be at the forefront of this field of research and could not have hoped for a better research partner than Mass. General Hospital (MGH) and Harvard Medical School,” said Sebastian De Beurs, Co-Founder of Healis Therapeutics. 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.comMedia ContactHealis Therapeutics, Incinfo@healisthera.com

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

Plus, news about Healis Therapeutics, NRx Pharmaceuticals, and Nuvalent: Denali Therapeutics’ $500M PIPE: The company is selling nearly 30 million shares at $17.06 apiece. Baker Brothers Life Sciences is the lead investor in the PIPE, per SEC filings , and will get a board seat. The funding coincides with Denali saying it nabbed $12.5 million from a third party last month for a LRRK2 program called BIIB122; however, Denali will take the program forward alone into a Phase IIa trial. Biogen is continuing to run a Phase IIb trial, and the pair will commercialize the drug together if it receives FDA approval. It previously discontinued a Phase III study for the program last June. Denali shares $DNLI rose roughly 10% premarket on Tuesday. — Max Gelman