Ad Scientiam launches program to develop gMG digital biomarkers

Ad Scientiam has launched a program to develop and validate new digital biomarkers for self-assessing patients with generalized myasthenia gravis (gMG).

The launch was announced on Rare Disease Day, Feb. 28, and is supported by Alexion, AstraZeneca Rare Disease.

“Easy-to-use digital tools have the potential to generate reliable and objective data to better understand the real impact of the disease on patients’ lives and also have the potential to demonstrate the benefits of novel therapies to keep disease under control,” Matthieu Lamy, Ad Scientiam’s president, said in a company press release.

Myasthenia gravis (MG) is a chronic autoimmune disease marked by muscle weakness and fatigue. It’s caused by self-reactive antibodies that attack proteins important in nerve-muscle communication. The disease typically begins with weakness in the muscles that control eye and eyelid movements (ocular MG), and often progresses to gMG, a more severe form wherein weakness spreads to other muscle groups.

No objective tools exist that allow patients to monitor their symptoms over time.

Ad Scientiam’s goal is to design, validate, and implement digital biomarkers so patients can continuously monitor their symptoms and disease progression.

Digital biomarkers are clinically-validated physiological and behavioral measures patients can collect using digital devices like smartphones. Recorded measurements are then processed by the company’s proprietary algorithms.

“We believe that empowering patients through real-time digital data sharing could strengthen communication between patients and healthcare professionals, and may enable more informed disease management decisions,” said Guido Sabatella, MD, global medical lead in Neurology at Alexion.

Preliminary studies identified clinically meaningful digital biomarkers to monitor patients with gMG.

“International, multicenter, comparative studies against clinical gold standards, such as the Quantitative Myasthenia Gravis score … will be deployed to confirm the clinical relevance of selected digital biomarkers,” said Saad Zinaï, MD, Ad Scientiam’s chief medical officer.

Research is continuing on the development of a digital medical device that could be used by patients to self-evaluate symptoms.

The newly-launched program also seeks to develop digital biomarkers for neuromyelitis optica spectrum disorders (NMOSD), an autoimmune disease that leads to inflammation of the optic nerve, which sends and receives signals from the eyes, and the spinal cord.

In 2019, Ad Scientiam released MSPilot, the first CE-marked software device for people with multiple sclerosis (MS).