UCB Inc., a biopharmaceutical company, has announced positive results for its RAISE Phase 3 trial (NCT04115293) investigating zilucoplan against placebo. According to a recent article in Biospace, zilucoplan met both primary and secondary endpoints in adult patients with generalized myasthenia gravis (gMG). The total enrollment included 174 adults with gMG. Patients received daily injected doses of zilucoplan or placebo for twelve weeks.
The drug is a peptide C5 inhibitor. After FDA, approval the drug will be self-administered by the patient via injection (subcutaneously). Zilucoplan showed a significant improvement from the information presented at baseline (study onset) in gMG Daily Living Profile (MG-ADL).
About gMG
gMG is an autoimmune disorder caused by a deficiency of acetylcholine. gMG affects approximately two hundred thousand patients in the EU, Japan, and the United States. Harmful autoantibodies cause damage to the neuromuscular junction, resulting in life-threatening muscle weakness. Other symptoms include double vision and problems with speech and swallowing. Studies show that women are affected in higher percentages than men, but the disease can strike at any age.
About Zilucoplan
Zilucoplan is a small, synthetic molecule. It binds and inhibits portions of the immune system named the “complement system” that is believed to be involved in stimulating harmful autoantibodies. Zilucoplan blocks the complement system, thus reducing the release of autoantibodies and slowing the progression of gMG.
Looking Forward
Plans are underway to proceed with regulatory submissions in Japan, Europe, and the United States for zilucoplan in the latter part of the year. Results of the zilucoplan trial follow positive results from UCB’s MycarinG Phase 3 study of the monoclonal antibody rozanolixizumab for gMG.(NCT03971422)
UCB Inc. is focused on developing medicines that transform the lives of patients with diseases of the immune system or the central nervous system.
