Hesperos Inc.'s Human-on-a-Chip technology played a crucial role in supporting Dianthus Therapeutics' Investigational New Drug (IND) submission to the FDA for DNTH103, which is now in Phase II clinical trials for generalized myasthenia gravis (gMG). The in vitro data from Hesperos provided key proof-of-concept evidence for the drug's mechanism of action.
DNTH103: A Novel Approach to gMG Treatment
Generalized myasthenia gravis is a chronic autoimmune disease characterized by the production of antibodies that disrupt nerve signal transmission to muscles, leading to muscle weakness. Dianthus Therapeutics' DNTH103 is a potent monoclonal antibody selectively targeting the classical pathway of the complement system, aiming to reduce the autoimmune attack on the neuromuscular junction.
The Phase II clinical trial (NCT06282159) is currently underway to evaluate the safety and efficacy of DNTH103 in patients with gMG. The current treatment landscape for gMG includes cholinesterase inhibitors, immunosuppressants, and, in some cases, thymectomy. DNTH103 represents a novel approach by directly targeting the complement system, potentially offering a more targeted and effective therapy.
Human-on-a-Chip Validates DNTH103 Mechanism
Hesperos' Human-on-a-Chip platform features a proprietary neuromuscular junction (NMJ) model. This model interconnects human cell compartments with devices that monitor muscle contraction and electrical activity in real-time, providing physiologically relevant functional readouts. Using this model, Hesperos researchers demonstrated that DNTH103 can improve nerve cell transmission and decrease muscle fatigue in the presence of gMG patient serum.
Lawrence Florin, CEO of Hesperos, Inc., stated, "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."
Implications for Drug Development
The successful application of Hesperos' Human-on-a-Chip technology in supporting the IND submission for DNTH103 highlights the potential of in vitro human biology models in preclinical drug development. By replicating key aspects of human physiology, these models can provide more meaningful insights into a drug's therapeutic profile, potentially reducing the reliance on animal testing and accelerating development timelines.
