Benzinga | Jan 6, 2022 08:06AM EST

Eiger BioPharma Offers Expectations For 2022 Catalysts, Milestones

- Phase 3 HDV D-LIVR (Lonafarnib) Study Topline Data Planned by End of 2022

- Phase 3 HDV LIMT-2 (Peginterferon Lambda) Study Enrolling and Dosing

- Phase 3 COVID-19 TOGETHER (Peginterferon Lambda) Study Topline Data 1H22

- Zokinvy MAA CHMP Opinion Expected 1H22

- Strong Cash Position of Approximately $106 Million

PALO ALTO, Calif., Jan. 6, 2022 /PRNewswire/ -- Eiger BioPharmaceuticals, Inc. (NASDAQ:EIGR), a commercial-stage biopharmaceutical company focused on the development of innovative therapies to treat and cure Hepatitis Delta Virus (HDV) and other serious diseases, today provided the company's outlook across multiple pipeline programs and operations, including planned 2022 catalysts and milestones.



"This is a pivotal year for Eiger as we plan for topline data from the landmark D-LIVR study by year end. D-LIVR is the largest trial conducted in HDV and if positive will support regulatory filings for Lonafarnib-based regimens," said David Cory, President and CEO of Eiger. "HDV is a large unmet medical need with over 12 million people suffering from this devastating disease around the globe. Our second registration enabling clinical trial in HDV, LIMT-2, a Phase 3 study of Peginterferon Lambda, is now enrolling and dosing. Lonafarnib and Peginterferon Lambda are well positioned to become foundational therapies to treat and cure HDV."

Program Highlights

HDV Platform

Lonafarnib for Hepatitis Delta Virus Infection

* First-in-class, oral prenylation inhibitor

* D-LIVR Phase 3 study with potential approval of two Lonafarnib-based regimens All oral Lonafarnib / ritonavir and in combination with peginterferon alfa Fully enrolled N=407 Topline data planned by end of 2022

Peginterferon Lambda for Hepatitis Delta Virus Infection

* First-in-class well-tolerated interferon

* Potential to be interferon of choice in HDV combination therapies

* LIMT-2 Phase 3 study of Peginterferon Lambda monotherapy for HDV Enrolling and dosing patients, targeting N=150

Avexitide for Rare Metabolic Disorders

* Granted Breakthrough Therapy Designation for Congenital Hyperinsulinism (HI)

* Granted Rare Pediatric Disease Designation for HI -- PRV eligible

* Phase 3 ready in 2022

Zokinvy(r) for Progeria and Processing-Deficient Progeroid Laminopathies

* Successful U.S. commercial launch Approximately 80% of identified U.S. patients converted to commercial supply

* EMA review of MAA Ongoing discussions with CHMP primarily focused on additional statistical analyses of clinical data; CHMP opinion expected in first half of 2022

Peginterferon Lambda for COVID-19 Infection

* Novel mechanism of action, agnostic to variants and mutations

* TOGETHER Phase 3 study enrolling, targeting N=1,600

* Second positive interim futility analysis (N=1,003) completed in December 2021

* Topline data planned in 1H22

Corporate

* Appointed Kim Sablich, biopharma commercial expert, to Board of Directors

* Appointed Erik Atkisson as General Counsel and Chief Compliance Officer

* Cash, cash equivalents and investments of ~$106 million to begin 2022