Dianthus Therapeutics has unveiled in vitro results of its drug candidate in a pair of autoimmune disease models, supporting recent efforts to start mid-stage studies.
The first dataset from the blood of patients with myasthenia gravis showed the drug candidate, dubbed DNTH103, reached a 24.8% to 27.8% reduction from baseline in the fatigue index. The fatigue index measures improvements in neurotransmission and muscle contraction, according to a Saturday presentation at the European Academy of Neurology annual meeting in Helsinki.
Myasthenia gravis occurs when communication between the nerves and muscles breaks down at the neuromuscular junction, causing muscle weakness.
In the second dataset from the blood of patients with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP), the higher dose of DNTH103 restored levels of neuronal conduction velocity, according to a Sunday presentation at the confab. CIDP develops when the body’s immune system attacks the myelin that insulates and protects nerve cells.
Treatments for generalized myasthenia gravis (gMG) are currently limited to C5 inhibitors or FcRn inhibitors, and the former have an increased risk of serious bacterial infections, CEO Marino Garcia said in a Friday release. “Similarly, treatment options for patients with CIDP have traditionally been limited to intravenous or subcutaneous infusions of Ig,” Garcia said.
DNTH103 is a monoclonal antibody designed to target the classical complement pathway by blocking only active forms of the C1s protein. Its more selective mechanism of action could lower the risk of infection from encapsulated bacteria by preserving the immune activity of the remaining two complement pathways, according to Dianthus.
The results come at a time when the biotech is pushing DNTH103 through the clinic. In February, Dianthus started a Phase 2 trial of DNTH103 in gMG, with topline data anticipated in the second half of 2025. The company is also gearing up to start a Phase 2 CIDP study of the drug in the second half of the year.
Dianthus got FDA clearance in June to initiate a Phase 2 test of the drug candidate in patients with multifocal motor neuropathy. Topline results are expected in the second half of 2026.
In September, the biotech made its Nasdaq debut via a reverse merger around the same time it successfully completed a Phase 1 DNTH103 trial in healthy volunteers.