Eiger Bio’s Hypertension Drug Flunks Phase 2 Trial, Shares Tumble

Xconomy San Francisco — 

An Eiger BioPharmaceuticals drug being tested for the treatment of pulmonary arterial hypertension has failed a mid-stage study, and the drug developer says it will stop work on the compound for that condition.

News of the clinical trial failure cut the value of shares in Palo Alto, CA, based Eiger (NASDAQ: EIGR) nearly in half. The company’s stock price closed at $8.10 Tuesday, down 49.3 percent from last Friday’s closing price.

In pulmonary arterial hypertension (PAH), high blood pressure develops in the arteries that carry blood to the lungs. The condition leads to shortness of breath, chest pain, and fainting. Its cause is not known and there is no cure, according to the National Organization for Rare Disorders.

Eiger’s drug, ubenimex, blocks an enzyme, leukotriene B4 (LTB4), that is linked to inflammation in patients who have PAH. In the announcement of the Phase 2 results, the company said patients given the drug showed no improvement on a measure of blood flow, the main goal of the 45-patient study. The drug also failed to meet the trial’s secondary goal of increasing distance walked during a six-minute period. No safety problems were reported in the study.

Though Eiger will stop work on ubenimex as a PAH treatment, the company says it will continue a separate clinical trial testing the drug in lymphedema, the swelling of an arm or leg that is commonly caused by the removal of lymph nodes during cancer treatment. Eiger expects to report results from that Phase 2 study in the second half of the year.

Ubenimex is approved in Japan to supplement chemotherapy in the treatment of a quickly progressing form of leukemia in adult patients. Eiger licensed the drug from Nippon Kayaku in 2015, granting the California company rights to develop the drug in the U.S., Europe, and other countries for inflammatory diseases involving LTB4.

Eiger, which focuses on developing drugs for rare diseases, gained a public stock listing three years ago by merging with San Diego-based Celladon, after Celladon’s gene therapy for heart failure failed a clinical trial. Eiger management took over leadership of the combined company, and Eiger’s shareholders hold the larger stake in the business.

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