Ubenimex fails in LIBERTY study for pulmonary arterial hypertension and is discontinued for this condition.

Eiger BioPharmaceuticals, Inc. focused on the development and commercialization of targeted therapies for rare diseases, announced Phase II LIBERTY study results in pulmonary arterial hypertension (PAH) that demonstrated no improvement overall or in key subgroups for both the primary efficacy endpoint of pulmonary vascular resistance (PVR) and the secondary endpoint of 6-minute walk distance (6MWD). No safety signals attributed to ubenimex were identified in the preliminary analysis.

Further analysis of data, including biomarkers is ongoing, although the company will discontinue development of ubenimex in PAH based on these results. Eiger will continue to develop ubenimex for lymphedema based on its distinct mechanism of action impacting lymphangiogenesis as published in Science Translational Medicine (Tian et al, May 2017). Eiger is developing ubenimex for lymphedema in the ULTRA study, a multi-center, international, Phase II study in patients with primary and secondary lymphedema that is fully enrolled with data expected in the second half of 2018.