Eiger reports negative Phase ll results in trial of ubenimex

18th January 2018 (Last Updated January 18th, 2018 00:00)

EigerBio Pharmaceuticals has reported negative results from a Phase ll study evaluating ubenimex for treating pulmonary arterial hypertension (PAH), a type of high blood pressure that affects arteries in the lungs and the right side of the heart.

EigerBio Pharmaceuticals has reported negative results from a Phase ll study evaluating ubenimex for treating pulmonary arterial hypertension (PAH), a type of high blood pressure that affects arteries in the lungs and the right side of the heart.

Results of the LIBERTY study have shown that ubenimex was unable to meet the study's primary and secondary endpoints.

The study showed no improvement overall or in key subgroups for both the primary efficacy endpoint of pulmonary vascular resistance (PVR) and the secondary objective of a six-minute walking distance.

Eiger has not been able to identify any safety signals of ubenimex in the trial's preliminary analysis.

The company is still analysing findings such as biomarkers, and will discontinue the development of ubenimex for PAH.

"Eiger has a deep pipeline of products focused on rare diseases that was built to reduce risk against a single binary event."

However, Eiger plans to continue to develop ubenimex for lymphedema as part of its multi-centre, global, Phase ll ULTRA study in patients with primary and secondary lymphedema.

The trial has completed enrolling patients and expects to provide data in the second half of this year.

Eiger president and CEO David Cory said: “While we are disappointed with results from the LIBERTY study, we have always recognised that PAH is a complex disease and that this was a translational programme.

“Eiger has a deep pipeline of products focused on rare diseases that was built to reduce risk against a single binary event.

“Phase ll proof-of-concept has already been demonstrated in both hepatitis delta virus (HDV) infection and post-bariatric hypoglycemia (PBH).”

The LIBERTY trial enrolled around 45-60 patients who were randomised in a 2:1 ratio to receive ubenimex or matching placebo administered orally for a total of 24 weeks.