Eiger BioPharmaceuticals announced Phase 2 ULTRA study results in primary and secondary lymphedema of the lower limb demonstrated no improvement of ubenimex over placebo in the primary endpoint of skin thickness and secondary endpoints of limb volume and bioimpedance. No safety signals attributed to ubenimex were identified.
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Topline analysis suggests select, individual patient responses which clinical investigators believe warrant further exploration. The company plans no additional clinical work but will support these additional investigator analyses and will update if future findings suggest any potential pathway forward. Eiger would pursue such an option only through a strategic partnership.
"Eiger is advancing only the most promising programs in our pipeline for rare diseases," said David Cory, President and CEO. "The company is now focused on advancing plans for a new drug application (NDA) in Progeria, enrollment in the first-ever Phase 3 study in hepatitis delta virus (HDV) infection, and regulatory guidance in post-bariatric hypoglycemia (PBH) in 2019."