Aquavit Receives FDA Clearance for Two INDs to Initiate Clinical Trials With Its Botulinum Toxin
29 Apr 2023
INDClinical Study
NEW YORK, April 29, 2023 /PRNewswire/ -- 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).
Axillary hyperhidrosis affects 2-3% of people in the United States and nearly one-third of these individuals have stated that their sweating is either barely tolerable or is intolerable. Palmar hyperhidrosis is a condition affecting approximately 3% of the population. The market for treating hyperhidrosis was approximately USD 575.3 million in 2021. DTX-023 is on a biosimilar pathway to onabotulinumtoxinA and is anticipated to obtain many key therapeutic indications in addition to the commonly known aesthetic uses.
"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 organizations such as IBTXR (Institute for Botulinum Toxin Research)."
Aquavit is the first company in history to pursue an FDA approval for intradermal injection of botulinum toxin for the treatment of palmar hyperhidrosis. Aquavit is currently on the forefront of botulinum toxin application development and currently has a third IND approval pending before the FDA and will continue to expand its role in the industry.
"Botulinum toxins have been utilized 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.
About Aquavit Holdings
Aquavit Holdings is a biotechnology company focused on the development of botulinum toxin applications. Aquavit Holdings focuses on personalized applications of botulinum toxins to improve patients' health, maximize the efficiency of our medical community, and support the pharmacoeconomics of payers.
SOURCE Aquavit Holdings
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