Eiger BioPharmaceuticals has dosed the first patient in its Phase 2 LIBERTY study with its product candidate Bestatin for the treatment of pulmonary arterial hypertension.
LIBERTY is a multi-site, randomized, double-blind, placebo-controlled Phase 2 trial assessing Bestatin in PAH patients. About 45 people will receive either Bestatin or a placebo in a randomized assortment for 24 weeks.
Those who finish all 24 weeks of treatment will be eligible to enroll in an open-label extension study (LIBERTY2) to receive additional treatment with Bestatin. The extension study will allow patients to choose to receive Bestatin for at least 24 more weeks, and will provide complementary data on the safety, tolerability, and efficacy of the drug candidate.
“The goal of the LIBERTY study is to block LTB4 production with ubenimex as a novel and potentially disease modifying treatment for PAH,” said Dr Joanne Quan, MD, Eiger’s chief medical officer.
“Inflammation, now recognized as an important component of PAH, is not addressed by currently available therapies,” she said, adding that recently published preclinical studies from Stanford suggest that elevated LTB4 levels may play a role in the inflammatory component of PAH.
“Targeted LTB4 blockade may represent an important new therapeutic approach to this disease,” she added.