Source – Eiger BioPharmaceuticals
On June 29, 2023 Eiger BioPharmaceuticals announced a reduction in staffing by 25% and a strategic shift in its research and development (R&D) focus towards metabolic diseases. The decision comes after the US Food and Drug Administration (FDA) stated that a new study would be required for Eiger’s hepatitis delta virus (HDV) candidate, lonafarnib, before considering approval.
The CEO of Eiger, Dr. David Apelian, confirmed that these measures would enable the company to extend its financial resources until the end of the following year. Dr. Apelian, who recently assumed the permanent CEO position after serving as interim CEO since December 2022, had previously held roles as Eiger’s chief operating officer and executive medical officer.
Eiger had sought accelerated approval from the FDA for lonafarnib as a treatment for HDV, which is a virus that co-infects with the hepatitis B virus (HBV) and affects approximately 5% of the estimated 257 million individuals worldwide with chronic HBV infections.
However, the FDA determined that a confirmatory trial, not solely based on surrogate endpoints such as viral loads and liver function, would be necessary. Instead, the trial would need to focus on hard patient outcomes such as morbidity and mortality, posing a more significant challenge. Furthermore, patient selection criteria for the 48-week treatment would need to be established.
In response, Eiger has chosen to seek a partner for lonafarnib in the HDV indication, along with another HDV candidate called peginterferon lambda. The company will prioritize the development of avexitide, a GLP-1 receptor antagonist, for hyperinsulinemic hypoglycemia indications. Eiger has stated that it is actively engaged in discussions with potential partners.
Eiger has provided limited updates on avexitide since reporting the phase 2 PREVENT trial results in 2019, which evaluated the drug in patients with severe post-bariatric hypoglycemia (PBH) resulting from weight loss surgery. According to the company, avexitide is the only drug in development for PBH with a breakthrough designation. Eiger has reached alignment with the FDA regarding the design of a phase 3 study for avexitide.
Additionally, Eiger intends to explore the use of avexitide in congenital hyperinsulinism, an ultra-rare disease that leads to persistent hypoglycemia and potential irreversible brain damage.
Meanwhile, lonafarnib has already received FDA approval as Zokinvy for rare diseases such as Hutchinson-Gilford progeria syndrome (HGPS) and progeroid laminopathies. This approval has provided Eiger with a revenue stream of approximately $13 million in the past year.
“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. After a thorough examination of our programs, we are deploying our resources toward recognizing the compelling potential of avexitide in metabolic diseases. Our initial focus will be on post-bariatric hypoglycemia, or PBH , where we see the highest revenue potential, have demonstrated proof-of-concept in Phase II clinical trials, and have FDA alignment on Phase III endpoints, sample size, and study design. In the future, we also intend to develop avexitide for congenital hyperinsulinism as a second indication. We plan to provide further guidance next quarter on the progress of our business development efforts for our virology assets, as well as definitive plans for the PBH Phase III study initiation and key study milestones.”
“For our other late-stage assets, lonafarnib and peginterferon lambda, we believe the strength of our data and alignment on a regulatory path with FDA make them attractive to potential collaborators. We are actively engaged in discussions with potential partners.”
– David Apelian, MD, PhD, MBA, CEO of Eiger
“David has embraced his role as CEO, which was a natural transition given his proven tenure with Eiger as a board member and previous Chief Operating Officer. David’s extensive clinical development and regulatory experience gained from working at large pharmaceutical and biotechnology companies, combined with his strategic vision and previous leadership roles at Eiger, make him the right choice to lead Eiger.”
– Thomas Dietz, PhD, non-executive Chairman of the Board
