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Eiger BioPharmaceuticals Provides Update On 2020 Progress And 2021 Plans


Benzinga | Jan 7, 2021 08:07AM EST

Eiger BioPharmaceuticals Provides Update On 2020 Progress And 2021 Plans

PALO ALTO, Calif., Jan. 7, 2021 /PRNewswire/ -- Eiger BioPharmaceuticals, Inc (NASDAQ:EIGR), a commercial-stage biopharmaceutical company focused on the development and commercialization of foundational therapies for Hepatitis Delta Virus (HDV) infection, today updated on progress across its product pipeline, including planned 2021 milestones.

Lonafarnib in HDV

* First and only oral agent in development for HDV

* Phase 3 D-LIVR study (N=400) enrollment completion planned in 2021

* End of treatment data planned in 2022

Peginterferon Lambda (Lambda) monotherapy in HDV

* Well-tolerated interferon for weekly subcutaneous injection

* Phase 3 LIMT-2 study (N=150) planned start in 2H21

Lambda-Lonafarnib Combination in HDV

* Positive end of study Phase 2 LIFT data presented at AASLD 2020

* Publication expected in 2021

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

* U.S. FDA approval in November 2020

* U.S. commercial launch planned in January 2021

* EMA approval expected 2H21

Lambda in COVID-19

* Positive Phase 2 proof of concept data presented at RespiDART 2020

* Data support impact of baseline viral loads on viral clearance with Lambda

* Pre-IND package submitted to FDA with guidance expected in Q1 2021

Corporate

* PRV sale for $95M expected to close in January 2021; Eiger will retain 50%

* Pro forma cash, cash equivalents and investments of approximately $176M, reflecting $128.8M as of December 31, 2020 plus $47.5M from PRV sale proceeds anticipated in January 2021, expected to fund planned operations through at least Q4 2023

"Our priority in 2021 are our HDV programs, where we plan to complete D-LIVR enrollment and initiate the Lambda Phase 3 LIMT-2 study," said David Cory, President and CEO of Eiger. "Lonafarnib is the only oral therapy in development and Lambda is a well-tolerated interferon in development for HDV, both with the potential to become foundational chronic treatments with convenience and optionality for patients affected by this most serious form of viral hepatitis."






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