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DIANTHUS THERAPEUTICS ANNOUNCES FDA CLEARANCE TO INITIATE PHASE 2 TRIAL OF DNTH103 IN MULTIFOCAL MOTOR NEUROPATHY (MMN)

Dianthus Therapeutics Announces First Participant Dosed in Phase 1 Trial of DNTH103, a Selective Inhibitor of the Classical Complement Pathway

November 30, 2022 at 12:00 AM EST

Study of lead program will provide proof-of-concept to enable further clinical development in severe autoimmune diseases; full cohort data available in 2H’23

DNTH103 is a next-generation monoclonal antibody that selectively targets only the active form of the C1s protein in the classical complement pathway

DNTH103 designed as an infrequent and convenient subcutaneous injection to improve upon high dose volume and frequency of currently available complement pathway inhibitors

 

New York City and Waltham, Mass., November 30, 2022 – Dianthus Therapeutics, a biotechnology company dedicated to advancing the next generation of antibody complement therapeutics, today announced that the first healthy volunteers have been dosed in a Phase 1 clinical trial of its lead monoclonal antibody, DNTH103.

“Today marks a pivotal milestone for Dianthus as we transition into a clinical stage company,” said Marino Garcia, President and Chief Executive Officer, Dianthus Therapeutics. “Data from this Phase 1 study will provide important information about the safety, tolerability, pharmacokinetics and pharmacodynamics of DNTH103 in healthy adult volunteers across single and multiple ascending dose cohorts, demonstrating potential proof-of-concept to advance DNTH103 into severe autoimmune diseases where other modalities have not fully addressed the unmet medical need.”

DNTH103 is a selective inhibitor of the active C1s protein in the complement system’s classical pathway. Classical pathway activity is implicated in driving morbidity in a range of autoimmune disorders. Unlike therapies that broadly inhibit the complement system, selective inhibition of the classical pathway preserves immune activity of the lectin and alternative complement pathways against bacterial infections.

“All currently approved complement antibody therapies indiscriminately bind to both active and inactive complement proteins – meaning a large, sometimes frequent dose must be administered while a significant portion of the drug acts unnecessarily on inert proteins,” said Simrat Randhawa, M.D., Chief Medical Officer, Dianthus Therapeutics. “DNTH103 selectively targets the active form of C1s – allowing more of the drug to have a therapeutic effect so we can potentially reduce dose volume and frequency of administration. In addition, by leaving the lectin and alternative pathways intact, the risk of infection from encapsulated bacteria is lower for DNTH103 versus commonly used C5 and C3 inhibitors.”

About Dianthus Therapeutics

Dianthus Therapeutics is a clinical-stage biotechnology company dedicated to designing and delivering novel, best-in-class monoclonal antibodies with improved selectivity and potency over existing complement therapies. Based in New York City and Waltham, Mass. Dianthus is comprised of an expert team of biotech and pharma executives who are leading the next generation of antibody complement therapeutics to deliver transformative medicines for patients with severe autoimmune diseases. Dianthus raised a $100M Series A in April 2022 co-led by 5AM Ventures, Avidity Partners, and Fidelity Management & Research Company, with participation from additional investors including Wedbush Healthcare Partners and founding investors Fairmount, Tellus BioVentures, and Venrock Healthcare Capital Partners. To learn more, please visit www.dianthustx.com and follow us on Twitter and LinkedIn.

  

Media Contact

Amanda Sellers, Verge Scientific Communications

asellers@vergescientific.com