Exhibit 99.1
Eiger to Discontinue Phase 3 LIMT-2 Trial of
Peginterferon Lambda in Patients with Chronic Hepatitis Delta
Palo Alto, Calif., September 12, 2023 /PRNewswire/ — Eiger
BioPharmaceuticals, Inc. (Nasdaq:EIGR), a commercial-stage biopharmaceutical company focused on the development of innovative therapies for rare metabolic diseases, today announced its decision to discontinue the Phase 3 LIMT-2 study of peginterferon lambda in patients with chronic hepatitis delta (CHD). The decision is based on the recommendation of the Data Safety Monitoring Board (DSMB) for the study following its quarterly
safety review. In a communication dated September 7, 2023, the DSMB recommended the discontinuation of the LIMT-2 study due to observations of four patients with hepatobiliary events that resulted
in liver decompensation.
“The study discontinuation is disappointing, especially for patients with chronic hepatitis delta who have limited
treatment options,” said David Apelian, MD, PhD, MBA, CEO of Eiger. “We will work closely with FDA and our investigators to conduct an orderly termination of the LIMT-2 study in the
interest of patient safety.”
The Phase 3 LIMT-2 study is an open-label, parallel-arm clinical trial that randomized patients with well-compensated CHD infection to one of two treatment groups: peginterferon lambda 180 mcg QW for 48 weeks with 24 weeks
follow-up (Arm 1, n=105), or no treatment for 12 weeks followed by peginterferon lambda treatment for 48 weeks with 24 weeks of follow-up (Arm 2, n=53). In July, the
trial completed enrollment of 158 patients in 12 countries across 48 investigator sites.
Dr. Apelian added, “As we look toward the future for
Eiger, we will continue to execute on our strategic pivot, announced on June 29 of this year, and seek the financial resources required to advance the Company’s development activities on avexitide in hyperinsulinemic hypoglycemia
indications. We continue to evaluate strategic partnering options for our virology assets. Eiger is no longer in active discussions with potential partners for a worldwide license for peginterferon lambda.”
About Eiger
Eiger is a commercial-stage
biopharmaceutical company focused on the development of innovative therapies for rare metabolic diseases. Eiger’s lead product candidate, avexitide, is a well characterized,
first-in-class GLP-1 antagonist for the treatment of post-bariatric hypoglycemia (PBH) and congenital hyperinsulinism (HI).
Avexitide is the only drug in development for PBH with Breakthrough Therapy designation from the FDA.
For additional information about Eiger and its
clinical programs, please visit www.eigerbio.com.
Note Regarding Forward-Looking Statements
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1995. All statements other than statements of historical facts, including statements regarding our future financial condition, timing for and outcomes of clinical results, prospective products, preclinical and clinical pipelines, regulatory
objectives, business strategy and plans and