Eiger Bio scraps a mid-stage program after researchers record a clear flop in PAH, shares skid lower
Eiger BioPharmaceuticals $EIGR is scrapping one of its mid-stage programs for pulmonary arterial hypertension after their Phase II trial for ubenimex failed on several key fronts.
Researchers for Palo Alto, CA-based Eiger concluded that there was “no improvement overall or in key subgroups for both the primary efficacy endpoint of pulmonary vascular resistance and the secondary endpoint of 6-minute walk distance.” And now they’ll take a second look at the biomarkers while the company moves on with the rest of the programs they have in their rare disease pipeline.
Eiger, though, isn’t done with the drug itself. Ubenimex is in another Phase II trial for lymphedema, with data expected in the second half of this year. And the CEO sought to stem a rout on its stock price with assurances that a number of mid-stage catalysts await in 2018.
That wasn’t too effective, though, for the small biotech. The stock plunged close to 40% in pre-market trading.
“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,” said David Cory, president and CEO. “Eiger has a deep pipeline of products focused on rare diseases that was built to reduce risk against a single binary event. Phase II proof of concept has already been demonstrated in both Hepatitis Delta Virus Infection and Post-Bariatric Hypoglycemia. 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.”