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Primary sclerosis cholangitis (primary sclerosing cholangitis, PSC) is an unexplained chronic progressive disease characterized by inflammation, fibrosis, and stenosis of medium and large bile vessels in the liver and/or in the outer bile system of the liver.
uk, the incidence of PSC was 0.68 per 100,000 years in 1998-2014 and the age-standard prevalence rate was 5.58 per 100,000 years.
biotechnology company Chemomab announced today that the European Commission (EC) has granted its main candidate, CM-101, the status of orphan drugs (ODD) for the treatment of primary sclerosis bileitis (PSC), in accordance with the positive advice of the European Medicines Agency (EMA) Orphan Drug Products Committee (COMP).
previously, CM-101 had received ODD from the U.S. Food and Drug Administration (FDA).
CM-101 is a CCL24 closed monoclonal antibody with the effect of reducing fibrosis and inflammation.
CM-101 interferes with the main pathological processes that promote fibrosis and inflammation.
, as shown in many in vitro, in vitro and ionosome studies, CM-101 is very effective in improving fibrosis.
Adi Mor, CEO of Chemomab, said: "ODD is an important milestone in CM-101's global development plan.
from phase I clinical trials of CM-101 are encouraging and show that CM-101 is safe and has clinical antifibrosis.
we look forward to starting Phase IIa clinical trials in the third quarter of 2020.
there is currently no approved PSC treatment, there is an urgent need to develop new treatments to improve the quality of life of patients."
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