Positive news flowed in for ChemoCentryx, Inc., (CCXI) when it announced that the European Commission has granted orphan medicinal product designation to its pipeline candidate CCX168.
CCX168 is an orally-administered inhibitor that targets the receptor for a complement protein known as C5a.
ChemoCentryx is evaluating the candidate for the treatment of microscopic polyangiitis (MPA) and granulomatosis with polyangiitis (GPA) (formerly known as Wegener's Granulomatosis). The orphan designation was granted to CCX168 for the treatment of patients with MPA and GPA.
Orphan designation will provide certain benefits and incentives in the EU for the development of CCX168. These include protocol assistance, fee reductions and ten years of market exclusivity, once the drug is approved and commercialized.
We remind investors that the FDA had granted orphan drug designation to CCX168 for the treatment of anti-neutrophil cytoplasmic autoantibodies (ANCA)-associated vasculitides (AAV) and atypical hemolytic uremic syndrome (aHUS) earlier in 2014.
A phase II trial in patients with AAV is currently ongoing in Europe and a second phase II trial is being initiated in North America.
ChemoCentryx is working hard to develop CCX168 for treating various diseases. The company plans to initiate a phase II proof-of-concept clinical trial in aHUS by the end of 2014 along with additional phase II proof-of-concept clinical trials in IgA nephropathy and lupus nephritis in the first half of 2015.
We note that ChemoCentryx currently has no approved product in its portfolio. Hence, speedy development and commercialization of CCX168 greatly boost growth prospects of the company.
ChemoCentryx presently carries a Zacks Rank #2 (Buy). Other well-placed stocks in the broader health care sector include Sucampo Pharmaceuticals (SCMP), Valeant Pharmaceuticals (VRX) and ArQule, Inc (ARQL). All three carry a Zacks Rank #1 (Strong Buy).
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