Ubenimex Ph II study fails to meet primary endpoint

Phase II LIBERTY study results in pulmonary arterial hypertension (PAH) for ubenimex 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), said the drug’s developer Eiger BioPharmaceuticals (Nasdaq: EIGR).

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, said Eiger, whose shares plunged 49.37% to $8.10 in regular trading yesterday.

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 2 study in patients with primary and secondary lymphedema that is fully enrolled with data expected in the second half of 2018.