Objective:

The ongoing DOMYA (NCT05564936) study’s objective is to validate ME&MG™ clinical performance by comparing individual’s Quantitative MG (QMG) scores to home-measured digital biomarkers’ scores in people with gMG and healthy controls (HCs).

Background:

Generalized Myasthenia Gravis (gMG) is a rare autoimmune disease characterized  by fluctuating muscle weakness, making it essential to monitor symptoms between infrequent clinical visits. ME&MGTM is a software as medical device (SaMD) allowing remote self-assessment of gMG symptoms using five digital biomarkers (dBMKs) measuring ptosis, dysarthria, respiratory function, upper and lower limb muscle weakness. In the ME&MGopen decentralized study, proof-of-concept was established with dBMKs’ scores correlating with MG-ADL (daily activities) and MG-QoL-15r (quality of life) sub-scores.

Design/Methods:

DOMYA aims to recruit 94 adult patients with anti-acetylcholine receptor antibody-positive gMG and 50 HCs in France and the USA. Patients are monitored for one year with in-clinic visits at days 0, 90 and 365, along with monthly home-performed ME&MGTM active tests in the mornings and evenings. HCs will perform active tests in-clinic on day 0 and at home on day 1. Correlation coefficients between dBMKs and  ptosis, speech, lung function, limb stretch sub-items of QMG, will be calculated to determine the clinical significance of dBMKs and, safety related to the SaMD will be reported.

Results:

As of October 2025, a total of 93 out of 94 gMG patients (France: 46; USA: 47) and 47 out of 50 HCs (France: 20; USA: 27) have been recruited; with 16 patients having already completed the study. Study completion is anticipated by November 2026.

Conclusions:

ME&MGTM dBMKs reliability and quality have been established in the ME&MGopen study. Validation of  their clinical performance and safety in DOMYA will further support dBMKs’ adoption for objective tracking of gMG symptoms in routine practice to support HCPs in their decision-making processes.