Hesperos Provides Support for an Investigational Product for a Phase II Clinical Trial with its Huma
September 24, 2024 02:26 PM Eastern Daylight Time
ORLANDO, Fla.–(BUSINESS WIRE)–Hesperos, a leader in recreating human biology for drug discovery, is pleased to announce its Human-on-a-Chip® technology played a role in supporting a client’s Investigational New Drug submission with the Food & Drug Administration for a Phase II clinical trial of its investigational product DNTH103, highlighting the contribution of in vitro proof-of-concept data.
“We are pleased that our Human-on-a-Chip® model further validates the potential role of DNTH103 as a treatment for gMG and supported Dianthus’ FDA submission for its Phase II gMG clinical trial”
Dianthus Therapeutics, Inc. is currently conducting a Phase II trial of DNTH103, a potent monoclonal antibody that selectively targets the classical pathway of the complement system, for the treatment of generalized myasthenia gravis (gMG) [NCT06282159]. gMG is a chronic autoimmune disorder triggered by the production of antibodies that interfere with muscle nerve signal transmission and lead to muscle weakness.
Hesperos’ proprietary neuromuscular junction (NMJ) model interconnects human cell compartments with devices that monitor muscle contraction and electrical activity in real-time, providing physiologically relevant functional readouts. Hesperos researchers demonstrated that, in the presence of gMG patient serum, DNTH103 can improve nerve cell transmission and thus decrease muscle fatigue in their preclinical NMJ model.
Dianthus presented these data at the American Academy of Neurology (AAN) Annual Meeting, which took place April 13-18, 2024 in Denver, Colorado and virtually and at the 10th Congress of the European Academy of Neurology (EAN), which took place June 29-July 2, 2024 in Helsinki. These presentations can be found in the Scientific Publications section of the Dianthus website.
“We are pleased that our Human-on-a-Chip® model further validates the potential role of DNTH103 as a treatment for gMG and supported Dianthus’ FDA submission for its Phase II gMG clinical trial,” said Lawrence Florin, CEO, Hesperos, Inc.
Hesperos, Inc.
Hesperos is a global contract research organization (CRO) specializing in preclinical drug development services through its Human-on-a-Chip® platform. By replicating key aspects of human biology (and thus avoiding expensive, time-consuming and often less informative animal testing), Human-on-a-Chip® platform models provide product development teams with more meaningful insights that can accurately predict an agent’s therapeutic profile while lowering costs and accelerating development timelines.
