Eiger BioPharmaceuticals said Monday it has completed enrollment of its phase 2 LIBERTY study to evaluate the effects of ubenimex added to current standard of care in patients with pulmonary arterial hypertension (PAH). A total of 61 patients were enrolled across 45 sites in the U.S. and Canada in less than one year.
Ubenimex is approved in Japan (brand name Bestatin) as an adjunct to chemotherapy agents to extend survival and to maintain remission after treatment for acute non-lymphocytic leukemia in adults. Ubenimex has been used for over 25 years in Japan and remains commercially available through Nippon Kayaku. Ubenimex has been granted Orphan Drug Designation for treatment of PAH by the U.S. Food and Drug Administration and European Medicines Agency (EMA).
Ubenimex is not approved for any indication in the U.S. or Europe.