Eiger Biopharmaceuticals displaying forte in development and commercialization of targeted therapies for rare diseases declared negative results for Phase 2 LIBERTY study in pulmonary arterial hypertension (PAH) that revealed no progress 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 were discerned from the preliminary analysis alluding to ubenimex. The company intends to discard development of ubenimex in PAH based on further analyses including biomarkers which is still underway. However, Eiger will continue to develop ubenimex for lymphedema based on its distinct mechanism of action impacting lymphangiogenesis 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.
David Cory, President and CEO said “While we are disappointed with results from the LIBERTY study, we have always recognized that PAH is a complex disease and that this was a translational program, Eiger has a deep pipeline of products focused on rare diseases that was built to reduce risk against a single binary event. Phase 2 proof of concept has already been demonstrated in both Hepatitis Delta Virus (HDV) Infection and Post-Bariatric Hypoglycemia (PBH). We look forward to our upcoming End of Phase 2 meeting for HDV with the agency in February 2018. Topline results from the Phase 2, 28 day PREVENT study in PBH as well as for the Phase 2 ULTRA study in primary and secondary lymphedema will be reported in the second half of 2018. The company will direct all resources to advance these important efforts.”
Image Source: Eiger Biopharmaceuticals