Dianthus Therapeutics unveils new bifunctional fusion protein DNTH312

Dianthus Therapeutics, Inc. (Nasdaq: DNTH) announced DNTH312, an investigational bifunctional fusion protein that combines claseprubart and TACI, targeting inhibition of active C1s (aC1s) and BAFF/APRIL pathways for the treatment of severe autoimmune diseases.

The company describes DNTH312 as internally developed and enhanced with YTE half-life extension technology. In preclinical testing, DNTH312 demonstrated comparable in vitro potency and aC1s inhibition to claseprubart across multiple functional assays. The molecule showed a non-human primate (NHP) half-life of 22 days, which the company said is similar to claseprubart's approximately 60-day half-life in humans.

In NHP studies, DNTH312 also showed a similar depth of IgM, IgA, and IgG reductions following a single dose compared to povetacicept, a BAFF/APRIL inhibitor currently in late-stage clinical development.

Dianthus said the molecule is intended to target autoantibody-mediated diseases including generalized Myasthenia Gravis (MG), Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), and Multifocal Motor Neuropathy (MMN), among others. The company said new intellectual property protection for DNTH312 is expected through at least 2047.

"DNTH312 combines upstream and downstream inhibition of pathways often responsible for the morbidity seen in autoantibody mediated diseases such as MG, CIDP and MMN," said Simrat Randhawa, MD, Executive Vice President and Head of Research and Development at Dianthus Therapeutics.

Dianthus said DNTH312 is targeting infrequent subcutaneous self-administration and aims to be Phase 1 ready by the end of 2027. DNTH312 is not approved as a therapy in any indication in any jurisdiction worldwide.

The announcement is based on a press release issued by Dianthus Therapeutics.

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