The botulinum toxin formulation "TYEMVERS®" injection 100 units from CKD BiO(063160) will begin a clinical trial in the United States to assess its potential to treat major depressive disorder.
CKD BiO said on the 30th that it received U.S. Food and Drug Administration (FDA) approval for a phase 1 clinical trial plan of TYEMVERS for a major depressive disorder (MDD) indication.
Healis Therapeutics, TYEMVERS's U.S. development partner, will conduct the trial, while CKD BiO will handle manufacturing and supply of the investigational drug.
Healis Therapeutics plans to run an open-label, single ascending dose (SAD) trial in healthy adults to evaluate TYEMVERS's safety, tolerability, and pharmacodynamic characteristics. It then plans to expand indications to neuropsychiatric disorders including major depressive disorder, post-traumatic stress disorder (PTSD), and social anxiety disorder.
Botulinum toxin has mainly been used in aesthetics, such as wrinkle improvement, but recently its use has been expanding into therapeutic areas like chronic migraine and muscle disorders based on its neurotransmitter modulation effects.
Mental illnesses such as depressive disorders are surging worldwide, but treatments centered on existing antidepressants and psychotherapy have limits, driving demand for new therapeutic approaches.
A CKD BiO official said, "With this FDA clinical approval, we have confirmed the potential to expand TYEMVERS's treatment areas," and added, "We will strengthen cooperation with global partners so it can become a new treatment option for patients with major depressive disorder beyond the aesthetics field."
TYEMVERS is a botulinum toxin product manufactured based on an exclusive German strain. It highlights differentiation with an HSA-free formulation that does not use human serum albumin (HSA), inclusion of L-histidine, and halal certification. CKD BiO is also set to launch a 200-unit product next month following the existing 100-unit product.