Dive Brief:
- Eiger's share price plummeted as low as 49% this week as its Phase 2 LIBERTY study of ubenimex showed no improvement overall or in key subgroups for the primary and secondary endpoints in patients with pulmonary arterial hypertension.
- The company has now shuttered the ubenimex PAH program, but is continuing its development in lymphedema.
- A readout of the ULTRA Phase 2 study in primary and secondary lymphedema is expected in the second half of 2018.
Dive Insight:
Pulmonary arterial hypertension is a rare and progressive lung disease with an unknown cause, affecting between one to two people per million in the U.S. There are a number of drugs already on the market, but some of these require intravenous or subcutaneous administration, or are associated with side effects.
To meet these challenges, a number of companies are testing potential drugs in clinical trials. These include Arena Pharmaceuticals' ralinepag, and Roche's Actemra (tocilizumab) has also been touted as a possibility. It's not been an easy market to crack though. One of the more recently approved drugs, Actelion, Inc.'s Uptravi (selexipag), delays disease progression and reduces the risk of hospitalization; however, it is costly and patient deaths have triggered a review from the European Medicines Agency.
Moreover, the Food and Drug Administration in August 2017 used its 'refuse-to-file' option to reject SteadyMed Ltd's drug/device combo Trevyvant (treprostinil PatchPump).
Eiger had hoped to step into this rather complex market, but on the results of the LIBERTY study, has decided to shift its focus elsewhere.
"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's clinical pipeline is now down to three indications, all in Phase 2: lonafarnib (LOWR HDV) and pegylated interferon lambda (LIMT HDV study) in hepatitis delta virus infection, exendin 9-39 in post-bariatric hypoglycemia (MAD study), and ubenimex in lymphedema (ULTRA study).
"We look forward to our upcoming End of Phase 2 meeting for hepatitis delta virus with the agency in February 2018. Topline results from the Phase 2, 28-day PREVENT study in post-bariatric hypoglycemia as well as for the Phase 2 ULTRA study in primary and secondary lymphedema will be reported in the second half of 2018."