Immunovant’s primary product candidate, RVT-1401, is a human recombinant anti-neonatal Fc receptor (FcRn) monoclonal antibody for the treatment of IgG mediated diseases. The antibody facilitates the degradation of IgG by targeting FcRn and preventing endogenous IgG—including auto-antibodies—from binding. The increased catabolism curtails the harmful immune response exhibited by auto-antibodies.1
Immunovant is currently conducting a single and multiple ascending dose Phase 1 clinical trial in healthy volunteers with plans to initiate a number of patient-based studies in early 2019. RVT-1401 is being developed as a subcutaneous injection, providing a convenient and minimally invasive treatment option for patients.
Mechanism of Action
FcRn prolongs the half-life of IgG and albumin by actively binding these proteins and recycling them to the cell surface. Anti-FcRn antibodies disrupt this process by selectively binding FcRn. The RVT-1401 antibody contains two engineered receptor sites that specifically bind FcRn with high affinity at a region that prevents IgG binding, but minimally impacts albumin. The engineered receptor sites, in conjunction with two natural FcRn ligand sites, enable favorable binding kinetics with the FcRn receptor compared to IgG.1
Indication: Myasthenia Gravis
Myasthenia gravis (MG) is a chronic autoimmune neuromuscular disease characterized by weakness and fatigue of voluntary muscles. The disease is caused by pathogenic antibodies that target the neuromuscular junction, including the acetylcholine receptor (AChR) and the muscle specific tyrosine kinase receptor (MuSK), disrupting normal function.2 MG is a rare disease that affects approximately 46,000 to 66,000 people in the United States.3 MG is more prevalent in women and tends to affect younger women. In men, MG tends to affect an older population.4,5
The clinical course of MG is variable but usually progressive.6 Symptoms typically emerge in the eyes (e.g., drooping eyes, double-vision, blurred vision) and progress into the face, throat, and limbs.7 The chronic nature of MG requires patients to cope with fluctuating symptoms and multiple treatment regimens for management. Overall, the persistent muscle weakness associated with MG often negatively interferes with patients’ ability to engage in daily and physical activities, including demands of work, family, and social functions.