For months now, the oxygen seemed to be dwindling on Eiger’s COVID ambitions, especially after the FDA declined to grant emergency use authorization for the company’s treatment in October 2022.
And now the company is descending down the mountaintop, pivoting toward phase 3-stage avexitide to treat metabolic disease, according to an announcement Thursday. But to further clinical development—and the life of the company generally—Eiger is laying off 25% of its staff and limiting spending on its hepatitis delta virus (HDV) program. Those moves plus an existing loan give Eiger enough cash to last a little more than a year, until the fourth quarter of 2024.
To lead this refocus, interim CEO David Apelian has been promoted to the permanent role after taking the reins in December. His first order of business is tightening the company’s fiscal belt.
“Today's environment necessitates prudent and strategic evaluation of how to advance our promising and diverse pipeline in order to develop potential breakthrough medicines for patients and to drive stockholder value,” he said in a release.
The initial focus of avexitide will be post-bariatric hypoglycemia, which Apelian describes as having “the highest revenue potential.” The company is aligned with the FDA on phase 3 endpoints, Apelian noted, so executing this new strategy is a matter of turning the clinical pipeline around, then tapping the gas.
As for Eiger’s virology assets—lonafarnib and peginterferon lambda—the search is on for a partnership. Both are now aimed at HDV, though the latter was previously submitted for emergency use authorization as a COVID treatment before ultimately being rejected.
That regulatory process is a year and a half the company can’t get back. Eiger first jumped to regulators in March 2022 after finding that peginterferon lambda halved the risk of COVID-19-related hospitalizations that lasted more than six hours in a phase 3 trial. The study was conducted across a dozen sights in Brazil primarily in the second half of 2021.
By September 2022, Eiger said it was unable to determine whether the FDA would authorize the treatment or if additional data was required. A month later, the FDA made it clear: no dice. Eiger said at the time that it was “disappointed” but that it had “strong conviction” that peginterferon lambda was a valuable treatment for COVID and other viral infections. The question now is whether other potential suitors agree.