According to a story from BioSpace, the biotech company Dianthus Therapeutics recently announced that the US Food and Drug Administration (FDA) has cleared the company’s phase 2 clinical trial. This trial will be investigating the company’s experimental candidate DNTH103 in people living with multifocal motor neuropathy, a rare disease.

About the Trial

The trial, designated MoMeNtum, will be a randomized, global study that will include the involvement of 36 people living with multifocal motor neuropathy. These patients will receive either the study agent or a placebo subcutaneously on a two-week dosing schedule. The treatment period will last 17 weeks with the potential for an open-label extension portion lasting up to 52 weeks. The primary endpoints are tolerability and safety profile of the regimen, with secondary endpoints including grip and muscle strength tests, time to IVIG therapy, and time to disease relapse.

About DNTH103

DNTH103 is an experimental monoclonal antibody developed as a selective inhibitor of the classical pathway which acts on only the active mode of the C1s protein. It utilizes half-life extension tech in order to allow less frequent dosing. DNTH103 has the potential to play a role in treating an array of autoimmune disorders. The antibody is currently being evaluated in another phase 2 trial in myasthenia gravis and a trial for chronic inflammatory demyelinating polyneuropathy (CIDP) is also being planned.

About Multifocal Motor Neuropathy

Multifocal motor neuropathy is a rare, progressively condition in which the muscles of the limbs progressively weaken over time. The disease is often misdiagnosed as amyotrophic lateral sclerosis. Although the cause of the disease isn’t entirely clear, most scientists agree that the disease is autoimmune in nature, in which the immune system produces antibodies that attack a healthy component of the nervous system. Symptoms often first begin in the hands and include muscle atrophy, cramping, weakness, foot drop, wrist drop, and frequent muscle twitches. These symptoms gradually worsen in severity over time. Hot or cold temperatures appear to exacerbate symptoms. The most common treatment for multifocal motor neuropathy is intravenous immunoglobulin (IVIg), though immunosuppressants such as rituximab or cyclophosphamide may also be used. 80 percent of patients respond to IVIg and require regular infusions. There is no cure. To learn more about multifocal motor neuropathy, click here.