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NEW YORK and WALTHAM, Massachusetts – Dianthus Therapeutics, Inc. (Nasdaq: DNTH), a biotechnology company focused on therapies for autoimmune diseases, announced the initiation of a Phase 2 study for its drug candidate DNTH103 in patients with Generalized Myasthenia Gravis (gMG). . The study follows the FDA’s approval of its investigational new drug (IND) application.
DNTH103, a monoclonal antibody, is designed to selectively inhibit the classical complement pathway implicated in gMG pathology by targeting the active form of the C1 protein. The drug is designed with YTE half-life extension technology, which allows dosing every two weeks via subcutaneous injection, which could offer a more convenient treatment regimen for patients.
The MaGic study is a global, randomized, double-blind, placebo-controlled study involving up to 60 patients positive for acetylcholine receptor (AchR) antibodies. The study consists of a 12-week treatment period followed by a 52-week open-label extension, with the primary endpoint being safety and tolerability. Secondary endpoints include assessments of activities of daily living and quantitative Myasthenia Gravis scores.
The first final results from the MaGic study are expected in the second half of 2025. Dianthus also plans to initiate additional Phase 2 studies for DNTH103 in other neuromuscular conditions, such as multifocal motor neuropathy and chronic inflammatory demyelinating polyneuropathy, later this year.
The company’s chief medical officer, Dr. Simrat Randhawa, expressed optimism about the drug’s potential, citing Phase 1 data that demonstrated a 60-day half-life and potent pathway inhibition. Dr. Mazen M. Dimachkie, of the University of Kansas Medical Center, also expressed excitement about the investigational drug’s potential to provide a safer, more convenient treatment for GMGM patients.
This information is based on a press release from Dianthus Therapeutics, Inc. The company is known for its work in developing novel complementary antibody therapies to treat serious autoimmune and inflammatory diseases.
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