PALO ALTO, Calif., Jan. 7, 2021 /PRNewswire/ — Eiger BioPharmaceuticals, Inc (Nasdaq:EIGR), a professional-phase biopharmaceutical corporation centered on the advancement and commercialization of foundational therapies for Hepatitis Delta Virus (HDV) an infection, these days up to date on development throughout its product pipeline, like prepared 2021 milestones.
Lonafarnib in HDV
- First and only oral agent in improvement for HDV
- Period 3 D-LIVR research (N=400) enrollment completion prepared in 2021
- Finish of treatment method knowledge planned in 2022
Peginterferon Lambda (Lambda) monotherapy in HDV
- Properly-tolerated interferon for weekly subcutaneous injection
- Section 3 LIMT-2 examine (N=150) prepared start out in 2H21
Lambda-Lonafarnib Combination in HDV
- Constructive end of review Section 2 Raise info offered at AASLD 2020
- Publication predicted in 2021
Zokinvy™ for Progeria and Processing-Deficient Progeroid Laminopathies
- U.S. Fda acceptance in November 2020
- U.S. business launch prepared in January 2021
- EMA approval envisioned 2H21
Lambda in COVID-19
- Beneficial Stage 2 proof of notion info offered at RespiDART 2020
- Information support impact of baseline viral hundreds on viral clearance with Lambda
- Pre-IND package submitted to Food and drug administration with steering expected in Q1 2021
- PRV sale for $95M expected to shut in January 2021 Eiger will keep 50%
- Professional forma cash, funds equivalents and investments of around $176M, reflecting $128.8M as of December 31, 2020 furthermore $47.5M from PRV sale proceeds expected in January 2021, envisioned to fund prepared functions by way of at least Q4 2023
“Our precedence in 2021 are our HDV systems, where by we system to comprehensive D-LIVR enrollment and initiate the Lambda Phase 3 LIMT-2 analyze,” said David Cory, President and CEO of Eiger. “Lonafarnib is the only oral treatment in improvement and Lambda is a properly-tolerated interferon in development for HDV, both with the potential to turn out to be foundational serious treatment options with benefit and optionality for people affected by this most really serious kind of viral hepatitis.”
Eiger is a business-stage biopharmaceutical enterprise focused on the development and commercialization of foundational therapies for Hepatitis Delta Virus (HDV) infection, the most major variety of human viral hepatitis.
Eiger is creating two complementary treatment options for HDV. Lonafarnib is a to start with-in-class, oral prenylation inhibitor in a world-wide Phase 3 demo. Peginterferon lambda is a to start with-in-course, effectively-tolerated form III interferon entering Period 3.
Zokinvy for the remedy of Hutchinson-Gilford Progeria Syndrome (HGPS or Progeria) and processing-deficient Progeroid Laminopathies is the Firm’s initially Fda approval. A Promoting Authorization Application (MAA) is less than critique by the European Medications Agency (EMA). Outside the U.S., Eiger’s founded global Managed Access Method, anticipated to span better than 40 international locations, makes sure all little ones and young grown ups with Progeria and Progeroid Laminopathies have access to therapy.
For additional details about Eiger and its medical systems, remember to visit www.eigerbio.com.
Take note Concerning Ahead-Hunting Statements
This push release has “ahead-looking” statements that entail considerable challenges and uncertainties. All statements other than statements of historic information, which includes statements pertaining to our foreseeable future fiscal issue, timing for and results of scientific benefits, company strategy and strategies and aims for potential operations, are forward-wanting statements. These ahead-searching statements incorporate terminology this sort of as “believe,” “will,” “may,” “estimate,” “keep on,” “foresee,” “contemplate,” “intend,” “target,” “task,” “ought to,” “program,” “assume,” “predict,” “could,” “most likely” or the negative of these phrases. Forward-searching statements are our present-day statements about our intentions, beliefs, projections, outlook, analyses or present-day expectations concerning, between other points, our anticipating sizeable milestones in 2021, the timing of our ongoing and planned scientific progress, which includes our ability to support the launch of a new merchandise and ship to specialty pharmacies the sufficiency of our money, income equivalents and investments to fund our functions through at the very least Q4 2023 the envisioned closing of the sale of our PRV our improvement systems for Zokinvy usually and the likely acceptance of Zokinvy in jurisdictions exterior of the U.S., including the EU the risks connected to the commercialization of Zokinvy, our ability to manufacture sufficient quantities of Zokinvy, and the industrial start of Zokinvy in the U.S., the industry possible for Zokinvy as a treatment method for Progeria and processing-deficient Progeroid Laminopathies our progression and enrollment of our Period 3 D-LIVR analyze in HDV our skill to keep source of our commercial and clinical demo materials our programs to advance Lambda in HDV in the U.S. and EU our capacity to changeover into a commercial phase biopharmaceutical business our means to finance the continued improvement of our development pipeline items and the opportunity for success of any of our product candidates. These statements issue product or service candidates that have not nevertheless been authorised for internet marketing by the U.S. Food items and Drug Administration (Fda). No illustration is made as to their safety or usefulness for the purposes for which they are becoming investigated. Various important variables could bring about true success or situations to differ materially from the ahead-on the lookout statements that Eiger tends to make, which include extra applicable pitfalls and uncertainties explained in the “Danger Aspects” sections in the Quarterly Report on Variety 10-Q for the quarter ended September 30, 2020 and Eiger’s subsequent filings with the SEC. The ahead-searching statements contained in this push launch are based on facts at the moment obtainable to Eiger and talk only as of the day on which they are made. Eiger does not undertake and specifically disclaims any obligation to update any ahead-looking statements, regardless of whether as a consequence of any new data, potential occasions, improved instances or in any other case.
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