The pharmaceutical industry is paying attention to whether Lenabasum, an investigational drug to treat systemic sclerosis, cystic fibrosis, and dermatomyositis, will arrive in Korea.

The Ministry of Food and Drug Safety on Monday gave the nod to EPS International Korea, a contract research organization (CRO), to go ahead with its plan for a phase-3 local clinical trial for JBT-101, known as Lenabasum (resunab). The experimental drug used to be called Anabasum.

Developed by U.S. firm Corbus Pharmaceuticals Holdings, Lenabasum will be assessed for efficacy and safety to treat systemic sclerosis in the phase-3, multicenter, randomized, double-blind, and placebo-controlled study.

The trial on 16 domestic patients will take place at Catholic University Seoul St. Mary's Hospital, Seoul National University Hospital, Asan Medical Center, and Hanyang University Hospital.

Systemic sclerosis is an autoimmune disease, and the cause has not yet been determined. The disease overproduces collagen and accumulates it to cause fibrosis. It also causes the skin to thicken or induces disorders of internal organs, including the lungs, heart, kidneys, the gastrointestinal tract and musculoskeletal system.

About 90,000 patients have systemic sclerosis in the U.S. and Europe, mainly middle-aged. And up to 80 percent of the patients are female.

JBT-101 binds to cannabinoid receptor type 2 (CB2), expressed on activated immune cells and fibroblasts, to treat inflammation and turn off fibrosis.

The remedy obtained approval in the U.S. in 2015 and Europe in 2017 as an orphan drug to treat systemic sclerosis.

lhs@docdocdoc.co.kr

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