Dianthus advances DNTH103 in Phase 2 trial for gMG By Investing.com
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NEW YORK and WALTHAM, Mass. – Dianthus Therapeutics, Inc. (Nasdaq: DNTH), a biotechnology firm focused on autoimmune disease therapies, announced the start of a Phase 2 trial for its drug candidate DNTH103 in patients with generalized Myasthenia Gravis (gMG). The trial follows the FDA’s clearance of the Investigational New Drug (IND) application.
DNTH103, a monoclonal antibody, is designed to selectively inhibit the classical complement pathway, which is implicated in the pathology of gMG, by targeting the active form of the C1s protein. The drug is engineered with YTE half-life extension technology, allowing for dosing every two weeks via subcutaneous injection, which could offer a more convenient treatment regimen for patients.
The MaGic trial is a global, randomized, double-blind, placebo-controlled study involving up to 60 patients who are acetylcholine receptor (AchR) antibody positive. The trial 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 daily living activities and quantitative scores related to Myasthenia Gravis.
Initial top-line results from the MaGic trial are expected in the second half of 2025. Dianthus also plans to initiate additional Phase 2 trials for DNTH103 in other neuromuscular conditions, such as Multifocal Motor Neuropathy and Chronic Inflammatory Demyelinating Polyneuropathy, within 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, from the University of Kansas Medical Center, also conveyed enthusiasm for the investigational drug’s potential to provide a safer and more convenient treatment for gMG patients.
This information is based on a press release statement from Dianthus Therapeutics, Inc. The company is known for its work in developing novel antibody complement therapeutics to treat severe autoimmune and inflammatory diseases.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.
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© Reuters.
NEW YORK and WALTHAM, Mass. – Dianthus Therapeutics, Inc. (Nasdaq: DNTH), a biotechnology firm focused on autoimmune disease therapies, announced the start of a Phase 2 trial for its drug candidate DNTH103 in patients with generalized Myasthenia Gravis (gMG). The trial follows the FDA’s clearance of the Investigational New Drug (IND) application.
DNTH103, a monoclonal antibody, is designed to selectively inhibit the classical complement pathway, which is implicated in the pathology of gMG, by targeting the active form of the C1s protein. The drug is engineered with YTE half-life extension technology, allowing for dosing every two weeks via subcutaneous injection, which could offer a more convenient treatment regimen for patients.
The MaGic trial is a global, randomized, double-blind, placebo-controlled study involving up to 60 patients who are acetylcholine receptor (AchR) antibody positive. The trial 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 daily living activities and quantitative scores related to Myasthenia Gravis.
Initial top-line results from the MaGic trial are expected in the second half of 2025. Dianthus also plans to initiate additional Phase 2 trials for DNTH103 in other neuromuscular conditions, such as Multifocal Motor Neuropathy and Chronic Inflammatory Demyelinating Polyneuropathy, within 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, from the University of Kansas Medical Center, also conveyed enthusiasm for the investigational drug’s potential to provide a safer and more convenient treatment for gMG patients.
This information is based on a press release statement from Dianthus Therapeutics, Inc. The company is known for its work in developing novel antibody complement therapeutics to treat severe autoimmune and inflammatory diseases.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.
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