Primer PacienteIinscrito en el Ensayo de Fase 2 para un Fármaco Experimental de EMRR

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.

En cualquier caso, la seguridad de IMU-838 no es garantía de su eficacia en el tratamiento de la EMRR. Los estudios clínicos de fase 2 aún son relativamente tempranos en el ciclo de desarrollo de fármacos, y la mayoría de los fármacos experimentales se detienen aquí. Los espectadores harían bien en atenuar su emoción hasta que se publiquen datos adicionales.

La EMRR es la forma más común de esclerosis múltiple. ¿Cree que un gran avance en el tratamiento de la EMRR podría conducir a nuevos tratamientos para otros tipos de EM? ¡Comparta sus anécdotas, ideas y deseos con la comunidad Patient Worthy! Este artículo ha sido traducido al español lo mejor posible dentro de nuestras habilidades. Reconocemos que tal vez no hayamos captado todas las matices y especificidades de su región, por lo que si tiene alguna sugerencia o desea ayudarnos a refinar nuestras traducciones, envíe un correo electrónico a ideas@patientworthy.com.

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