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approach & pipeline

DEFINED TARGETS.
BOUNDLESS IMPACT.

Dianthus Therapeutics is harnessing the power of selectivity to advance next-generation complement therapies to treat severe autoimmune diseases.

An artistic illustration of the immunoglobulin M (IgM) molecule shown in light purple, with a blue substructure attached to it.

OUR INNOVATION

Our lead antibody, DNTH103, is purposefully engineered with extended half-life, improved potency, and high selectivity for only the active C1s complement protein that drives disease pathology – enabling less frequent and more convenient self-administered subcutaneous injections.
 

Addressing both the disease and treatment burdens that disrupt the lives of patients.

An artistic illustration of an antibody in hues of blue and teal.

OUR FOCUS

DNTH103 is an investigational, long-acting monoclonal antibody engineered to potently and selectively inhibit the active form of C1s, a clinically validated target in the classical complement pathway.

As the classical pathway plays a significant role in disease pathology across a range of neuromuscular disorders, DNTH103 holds the potential to be a pipeline in a product – beginning with generalized Myasthenia Gravis (gMG), Multifocal Motor Neuropathy and Chronic Inflammatory Demyelinating Polyneuropathy.

Engineered with YTE half-life extension technology, DNTH103 is intended to be the first subcutaneous complement therapy that can be self-administered as infrequently as once every two weeks for patients with severe, classical pathway-driven autoimmune disorders.
 

So patients can live healthier lives to their fullest potential.

Scientific illustration of how Dianthus engineers its antibodies to target only the active form of complement proteins.Scientific illustration of how Dianthus engineers its antibodies to target only the active form of complement proteins.
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BUILDING A NEUROMUSCULAR FRANCHISE WITH DNTH103

Positive top-line Phase 1 data for DNTH103 from 60 healthy volunteers across eight single and multiple-ascending dose cohorts validate DNTH103’s potent classical pathway inhibition with an approximate 60-day extended half-life and a potentially differentiated safety profile. Dianthus is building a neuromuscular franchise with DNTH103 following the initiation of the Phase 2 MaGic trial in generalized Myasthenia Gravis in 1Q’24, the Phase 2 MoMeNtum trial in Multifocal Motor Neuropathy in 3Q’24, and planned initiation of a Phase 3 trial in Chronic Inflammatory Demyelinating Polyneuropathy by YE’24.

PIPELINE

DISCOVERY
PRECLINICAL
PHASE I
PHASE II
PHASE III
MILESTONES
Array

DNTH103 – subcutaneous active C1s antibody

PHASE I
Generalized Myasthenia Gravis (gMG)
PHASE II

Approximately 60,000 people in the United States live with gMG, a chronic autoimmune disorder that causes progressive muscle weakness. About 85% of people with gMG have AChR autoantibody-driven disease, a driven by classical complement pathway activation.

Milestones
  • Initiated Phase 2 in 1Q 2024
  • Top-line Phase 2 data in 2H 2025
  • Initiated Phase 2 in 1Q 2024
  • Top-line Phase 2 data in 2H 2025
Multifocal Motor Neuropathy (MMN)
PHASE I

Approximately 5,000 to 10,000 people in the United States live with MMN, a disease in which the immune system attacks peripheral nerve axons and myelin sheaths and classical complement pathway activation can facilitate progressive nerve damage. Up to 80% of patients are not adequately managed by current standard of care and there are no approved targeted biologic therapies for MMN.

Milestones
  • Initiated Phase 2 in 3Q 2024
  • Top-line Phase 2 data in 2H 2026
  • Initiated Phase 2 in 3Q 2024
  • Top-line Phase 2 data in 2H 2026
Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
PHASE I

Approximately 15,000 people in the United States live with CIDP, a neuromuscular condition driven by classical pathway activation that follows a relapsing-remitting or a progressive clinical course with the potential to result in substantial disability, loss of motor and sensory function. There are no approved targeted biologic therapies for CIDP.

Milestones
  • Phase 3 trial initiation by YE 2024
  • Phase 3 trial initiation by YE 2024

Ongoing Discovery

DISCOVERY
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