First Patient Enrolled in Phase 2 Trial for Experimental RRMS Drug

According to a publication from Multiple Sclerosis News Today, German biotechnology company Immunic Therapeutics has successfully enrolled the first participant for its phase 2 clinical trial for experimental relapsing-remitting multiple sclerosis drug IMU-838.

About Relapsing-Remitting Multiple Sclerosis

Relapsing-remitting multiple sclerosis(RRMS) is the most common form of the disease. Up to 85% of people diagnosed with multiple sclerosis are initially diagnosed with RRMS. It is characterized by repeated, clearly observable attacks of increasingly severe neurologic symptoms.

These occasional attacks, known as relapses, are often followed by periods of partial or total remission. During remission periods, symptoms may disappear and there may be no apparent progression of the disease. However, some symptoms may persist and become permanent.

Cases of RRMS are typically evaluated as it pertains to their activity and severity. Patients’ cases might be described as either active (with relapses or development of new symptoms) or inactive, as well as worsening or not worsening.

RRMS is caused by an intermittent mistaken immune response that attacks the protective myelin sheathes that coat the body’s nerve fibers, as well as the nerve fibers themselves. Damage to these nerves and their coatings is responsible for the symptoms of multiple sclerosis.

About IMU-838

IMU-838 is an inhibitor of an enzyme known as dihydroorotate dehydrogenase (DHODH), which is instrumental in the chemistry of immune cells. Inhibition of DHODH results in reduced inflammatory activity, such as that which is associated with multiple sclerosis attacks.

DHODH inhibition is already thought to be safe in most patients, according to Immunic Therapeutics’ chief medical officer, Dr. Andreas Muehler. “The safety and tolerability profiles of IMU-838 are well understood,“ Muehler said in his company’s press release.

Muehler is hopeful for IMU-838‘s performance in the new trial. The phase 2 study will be conducted at more than 40 sites throughout Europe, and will involve some 200 participants diagnosed with RRMS. This study will attempt to determine differences in efficacy between 35 mg/day and 45 mg/day doses, and will include a placebo group.

After nearly a half year (24 weeks), patients’ responses to the treatment will be evaluated. Patients will then have the option to participate in an open-label extended treatment period to help assess the drug’s long-term safety. The first patient enrollment has many in the multiple sclerosis community excited.

Regardless, the safety of IMU-838 is no guarantor of its effectiveness treating RRMS. Phase 2 clinical studies are still relatively early in the drug development cycle, and most experimental drugs stall here. Onlookers would do well to temper their excitement until additional data is published.

RRMS is the most common form of multiple sclerosis. Do you think a breakthrough in RRMS treatment could potentially lead to new treatments for other types of MS? Share your thoughts with Patient Worthy!

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