Clinical Research Alert: Phase 2 Study of NMD670 in Adults with Generalized Myasthenia Gravis (gMG)

Researchers at NMD Pharma A/S are working to better understand generalized myasthenia gravis (gMG) and study efficacy of a potentially new treatment.

The study

People who have generalized myasthenia gravis (gMG) may be eligible to participate in a phase 2 clinical trial (SYNAPSE-MG) to evaluate the safety, efficacy, and duration of effect of the investigational therapy NMD670 to treat gMG. NMD670 targets skeletal muscle and is designed to enhance muscle activation with the goal of restoring and maintaining muscle function. It is being evaluated for the ability to improve muscle strength, power, and endurance, and to decrease some types of fatigue in people with gMG.

This is a phase 2, double-blind, placebo-controlled study, which means that participants will be randomly assigned to receive doses of the study drug (one of three possible dose levels) or an inactive placebo control. The study will be approximately 8 weeks in duration. During this time, participants will attend 6 in-person study visits, which will include a screening visit, a baseline visit 3-4 weeks later, and then weekly visits until the end of the study. Importantly, patients receiving gMG therapy can continue it as planned and receive NMD670 in addition.

The drug will be administered orally (by mouth) two times a day. The effects of NMD670 will be evaluated using a number of assessments including but not limited to: QMG score and MG-ADL, dynamometry + physical examination, and several questionnaires on the quality of life and fatigue.

Study criteria

To be eligible for the research study, individuals must meet the following inclusion criteria:

• Adults aged 18–75
• Those with a confirmed diagnosis of gMG with a positive antibody test for AChR or MuSK autoantibodies
• Those who are able to take tablets by mouth

Individuals may not be eligible for the research study if they meet the following exclusion criteria:

• Active or untreated thymoma
• Ongoing psychiatric disorders
• Other (cardiovascular, renal, gastrointestinal, etc.) chronic untreated conditions that may prevent from study compliance according to the Principal Investigator

Please visit this link for the full listing of inclusion and exclusion criteria.

Interested in participating?

To learn more about the study, please email the study coordinator at contact@nmdpharma.com or fill in this form https://nmdclinicaltrials.com/clinical-trials/synapse-mg/