PALO ALTO, Calif., Jan. 7, 2021 /PRNewswire/ — Eiger BioPharmaceuticals, Inc (Nasdaq:EIGR), a business-phase biopharmaceutical enterprise concentrated on the growth and commercialization of foundational therapies for Hepatitis Delta Virus (HDV) an infection, today up-to-date on progress throughout its merchandise pipeline, together with prepared 2021 milestones.
Lonafarnib in HDV
- Very first and only oral agent in development for HDV
- Stage 3 D-LIVR analyze (N=400) enrollment completion planned in 2021
- Conclude of treatment method info prepared in 2022
Peginterferon Lambda (Lambda) monotherapy in HDV
- Effectively-tolerated interferon for weekly subcutaneous injection
- Section 3 LIMT-2 study (N=150) planned get started in 2H21
Lambda-Lonafarnib Combination in HDV
- Optimistic stop of analyze Section 2 Raise data introduced at AASLD 2020
- Publication anticipated in 2021
Zokinvy™ for Progeria and Processing-Deficient Progeroid Laminopathies
- U.S. Food and drug administration approval in November 2020
- U.S. business launch prepared in January 2021
- EMA approval predicted 2H21
Lambda in COVID-19
- Favourable Section 2 evidence of principle information introduced at RespiDART 2020
- Details assistance effect of baseline viral loads on viral clearance with Lambda
- Pre-IND package submitted to Fda with advice predicted in Q1 2021
- PRV sale for $95M envisioned to near in January 2021 Eiger will keep 50%
- Professional forma hard cash, cash equivalents and investments of somewhere around $176M, reflecting $128.8M as of December 31, 2020 as well as $47.5M from PRV sale proceeds predicted in January 2021, expected to fund prepared operations via at least Q4 2023
“Our precedence in 2021 are our HDV programs, where by we strategy to comprehensive D-LIVR enrollment and initiate the Lambda Section 3 LIMT-2 review,” stated David Cory, President and CEO of Eiger. “Lonafarnib is the only oral remedy in enhancement and Lambda is a perfectly-tolerated interferon in improvement for HDV, the two with the potential to turn out to be foundational continual therapies with comfort and optionality for clients impacted by this most serious variety of viral hepatitis.”
Eiger is a business-phase biopharmaceutical business centered on the improvement and commercialization of foundational therapies for Hepatitis Delta Virus (HDV) an infection, the most critical variety of human viral hepatitis.
Eiger is acquiring two complementary treatment plans for HDV. Lonafarnib is a to start with-in-class, oral prenylation inhibitor in a world-wide Phase 3 demo. Peginterferon lambda is a initial-in-class, very well-tolerated variety III interferon moving into Stage 3.
Zokinvy for the procedure of Hutchinson-Gilford Progeria Syndrome (HGPS or Progeria) and processing-deficient Progeroid Laminopathies is the Company’s very first Food and drug administration acceptance. A Promoting Authorization Application (MAA) is below evaluate by the European Medications Company (EMA). Exterior the U.S., Eiger’s set up international Managed Access Application, anticipated to span increased than 40 nations, assures all small children and younger grown ups with Progeria and Progeroid Laminopathies have accessibility to remedy.
For extra data about Eiger and its scientific courses, make sure you take a look at www.eigerbio.com.
Note Regarding Forward-Searching Statements
This press release is made up of “forward-looking” statements that require considerable risks and uncertainties. All statements other than statements of historic information, such as statements concerning our long run monetary ailment, timing for and results of clinical final results, company approach and programs and objectives for long term operations, are forward-hunting statements. These forward-looking statements incorporate terminology these kinds of as “believe,” “will,” “may,” “estimate,” “continue,” “anticipate,” “contemplate,” “intend,” “target,” “project,” “should,” “plan,” “expect,” “predict,” “could,” “potentially” or the detrimental of these phrases. Forward-seeking statements are our recent statements about our intentions, beliefs, projections, outlook, analyses or present-day expectations regarding, amid other issues, our anticipating important milestones in 2021, the timing of our ongoing and prepared scientific progress, including our means to assistance the launch of a new solution and ship to specialty pharmacies the sufficiency of our hard cash, dollars equivalents and investments to fund our functions by means of at least Q4 2023 the anticipated closing of the sale of our PRV our development programs for Zokinvy typically and the opportunity approval of Zokinvy in jurisdictions outside the house of the U.S., together with the EU the risks associated to the commercialization of Zokinvy, our capability to manufacture ample portions of Zokinvy, and the commercial start of Zokinvy in the U.S., the marketplace prospective for Zokinvy as a procedure for Progeria and processing-deficient Progeroid Laminopathies our progression and enrollment of our Stage 3 D-LIVR research in HDV our capacity to manage offer of our commercial and clinical trial materials our ideas to advance Lambda in HDV in the U.S. and EU our capability to changeover into a business phase biopharmaceutical organization our means to finance the ongoing progression of our enhancement pipeline products and the likely for accomplishment of any of our products candidates. These statements concern products candidates that have not however been authorised for marketing by the U.S. Foodstuff and Drug Administration (Food and drug administration). No illustration is built as to their security or usefulness for the functions for which they are remaining investigated. Different important aspects could lead to precise effects or situations to vary materially from the forward-on the lookout statements that Eiger would make, such as extra relevant pitfalls and uncertainties explained in the “Risk Factors” sections in the Quarterly Report on Form 10-Q for the quarter finished September 30, 2020 and Eiger’s subsequent filings with the SEC. The ahead-searching statements contained in this press release are dependent on details now offered to Eiger and communicate only as of the date on which they are manufactured. Eiger does not undertake and specially disclaims any obligation to update any ahead-searching statements, whether as a outcome of any new data, potential occasions, improved conditions or if not.
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