Aquavit Initiates Clinical Trials With Its Botulinum Toxin

Aquavit Holdings (Aquavit), a biotechnology company focused on the development of botulinum toxin applications, announced today that it has received FDA clearance to initiate clinical trials for DTX-023 and DTX-024, following its submission of Investigational New Drug Applications.

Aquavit will begin its Phase II/Phase III trials for DTX-023 (aqubotulinumtoxinA) and DTX-024 (aqubotulinumtoxinA with intradermal microinjector) under the study protocol titled S.W.E.A.T. I™ (Safety with Efficacy of AQUATOX for primary Axillary hyperhidrosis Trial) and S.W.E.A.T. II™ (Safety with Efficacy of AQUATOX for palmar hyperhidrosis Trial).

"We are thrilled with the FDA's green light of DTX-023 and DTX-024. We will focus on successfully completing S.W.E.A.T. I™ and II™ in a timely manner while anticipating the IND approval of DTX-025 in the near future," said Sobin Chang, MPH., Chief Executive Officer of Aquavit. "We are truly grateful to our investigators who signed on early for the studies, valuable clinical advisors, and quality research organisations such as IBTXR (Institute for Botulinum Toxin Research)."

Aquavit is the first company in history to pursue FDA approval for intradermal injection of botulinum toxin for the treatment of palmar hyperhidrosis.

"Botulinum toxins have been utilised for aesthetic and therapeutic indications for over three decades. However, the lack of diversity of the industry limits the potential for new research topics and innovations. We are excited about the possibility of completing our clinical trials and being able to use DTX-023 and DTX-024 to treat the unmet needs of so many patients," added Churlsu Kwon, MD. PhD. MPH., Chief Medical Officer of Aquavit.