Eiger BioPharmaceuticals Announces Outlook and Planned 2022 Catalysts and Milestones
"This is a pivotal year for
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® for Progeria and Processing-Deficient Progeroid Laminopathies
- Successful
U.S. commercial launch- Approximately 80% of identified
U.S. patients converted to commercial supply
- Approximately 80% of identified
- 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
About
For additional information about Eiger and its clinical programs, please visit www.eigerbio.com
Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts, including statements regarding our future financial condition, timing for and outcomes of clinical results, business strategy and plans and objectives for future operations, are forward-looking statements. Forward-looking statements are our current statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things, our anticipated significant milestones in 2022; the timing of our ongoing and planned clinical development; the sufficiency of our cash, cash equivalents and investments to fund our operations; expectations regarding the timing and availability of topline data from our Phase 3 D-LIVR study in HDV; the ability to fully enroll the Phase 3 LIMT-2 study; initiating a Phase 3 study for avexitide in congenital hyperinsulinism; the approval of Zokinvy in jurisdictions outside of the
Investors and Media:
Sri Ryali – CFO
Email: [email protected]
Phone: 1-650-272-6138
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