– Period 3 HDV D-LIVR (Lonafarnib) Planned to Full Enrollment in 2021
– Phase 3 HDV LIMT-2 (Lambda) Planned to Initiate in 2H21
– Zokinvy™ EMA Approval Predicted in 2H21
– Powerful Money Place with ~$176M Pro Forma Money to Start off 2021
PALO ALTO, Calif., Jan. 7, 2021 /PRNewswire/ — Eiger BioPharmaceuticals, Inc (Nasdaq:EIGR), a commercial-phase biopharmaceutical corporation focused on the progress and commercialization of foundational therapies for Hepatitis Delta Virus (HDV) an infection, currently up-to-date on development across its merchandise pipeline, like planned 2021 milestones.
Lonafarnib in HDV
- First and only oral agent in improvement for HDV
- Period 3 D-LIVR examine (N=400) enrollment completion planned in 2021
- Close of cure data planned in 2022
Peginterferon Lambda (Lambda) monotherapy in HDV
- Perfectly-tolerated interferon for weekly subcutaneous injection
- Period 3 LIMT-2 research (N=150) prepared start out in 2H21
Lambda-Lonafarnib Combination in HDV
- Positive close of study Phase 2 Elevate knowledge offered at AASLD 2020
- Publication predicted in 2021
Zokinvy™ for Progeria and Processing-Deficient Progeroid Laminopathies
- U.S. Food and drug administration acceptance in November 2020
- U.S. commercial launch planned in January 2021
- EMA approval predicted 2H21
Lambda in COVID-19
- Constructive Section 2 proof of notion knowledge introduced at RespiDART 2020
- Info support impact of baseline viral hundreds on viral clearance with Lambda
- Pre-IND deal submitted to Fda with assistance envisioned in Q1 2021
- PRV sale for $95M expected to close in January 2021 Eiger will retain 50%
- Pro forma cash, money equivalents and investments of around $176M, reflecting $128.8M as of December 31, 2020 in addition $47.5M from PRV sale proceeds anticipated in January 2021, envisioned to fund prepared functions by way of at the very least Q4 2023
“Our precedence in 2021 are our HDV packages, the place we approach to entire D-LIVR enrollment and initiate the Lambda Period 3 LIMT-2 review,” stated David Cory, President and CEO of Eiger. “Lonafarnib is the only oral remedy in development and Lambda is a well-tolerated interferon in advancement for HDV, each with the prospective to develop into foundational serious treatment plans with advantage and optionality for clients afflicted by this most major variety of viral hepatitis.”
About Eiger Eiger is a professional-stage biopharmaceutical corporation targeted on the improvement and commercialization of foundational therapies for Hepatitis Delta Virus (HDV) infection, the most major sort of human viral hepatitis.
Eiger is building two complementary treatments for HDV. Lonafarnib is a 1st-in-course, oral prenylation inhibitor in a global Stage 3 trial. Peginterferon lambda is a to start with-in-course, properly-tolerated style III interferon coming into Period 3.
Zokinvy for the therapy of Hutchinson-Gilford Progeria Syndrome (HGPS or Progeria) and processing-deficient Progeroid Laminopathies is the Company’s initially Food and drug administration approval. A Promoting Authorization Application (MAA) is less than review by the European Medications Agency (EMA). Outside the U.S., Eiger’s proven worldwide Managed Entry Plan, anticipated to span better than 40 international locations, assures all little ones and youthful adults with Progeria and Progeroid Laminopathies have entry to procedure.
For added data about Eiger and its clinical plans, please visit www.eigerbio.com.
Take note Regarding Ahead-Looking StatementsThis push release consists of “forward-searching” statements that include significant challenges and uncertainties. All statements other than statements of historic points, which include statements about our potential economic situation, timing for and results of medical success, organization method and designs and aims for long term operations, are ahead-on the lookout statements. These ahead-on the lookout statements contain terminology this kind of as “believe,” “will,” “might,” “estimate,” “continue,” “foresee,” “contemplate,” “intend,” “goal,” “venture,” “should really,” “program,” “assume,” “predict,” “could,” “perhaps” or the destructive of these phrases. Forward-wanting statements are our current statements about our intentions, beliefs, projections, outlook, analyses or present-day expectations concerning, among the other matters, our anticipating sizeable milestones in 2021, the timing of our ongoing and prepared medical improvement, like our capability to support the launch of a new product or service and ship to specialty pharmacies the sufficiency of our hard cash, income equivalents and investments to fund our operations via at minimum Q4 2023 the envisioned closing of the sale of our PRV our improvement programs for Zokinvy generally and the prospective approval of Zokinvy in jurisdictions outside of the U.S., which includes the EU the dangers relevant to the commercialization of Zokinvy, our capacity to manufacture adequate quantities of Zokinvy, and the commercial launch of Zokinvy in the U.S., the industry potential for Zokinvy as a treatment for Progeria and processing-deficient Progeroid Laminopathies our progression and enrollment of our Stage 3 D-LIVR review in HDV our potential to keep supply of our industrial and medical demo products our plans to progress Lambda in HDV in the U.S. and EU our capacity to changeover into a professional phase biopharmaceutical firm our potential to finance the continued improvement of our growth pipeline items and the possible for achievement of any of our product or service candidates. These statements concern product or service candidates that have not yet been accepted for advertising and marketing by the U.S. Foods and Drug Administration (Fda). No representation is built as to their protection or performance for the reasons for which they are remaining investigated. Various significant aspects could induce genuine results or situations to vary materially from the ahead-searching statements that Eiger helps make, which includes supplemental applicable pitfalls and uncertainties explained in the “Hazard Elements” 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 forward-wanting statements contained in this push launch are primarily based on info at this time readily available to Eiger and communicate only as of the day on which they are made. Eiger does not undertake and precisely disclaims any obligation to update any forward-on the lookout statements, whether as a result of any new information and facts, long term occasions, modified situation or usually.
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