PALO ALTO, Calif., Jan. 7, 2021 /PRNewswire/ — Eiger BioPharmaceuticals, Inc (Nasdaq:EIGR), a industrial-stage biopharmaceutical firm targeted on the growth and commercialization of foundational therapies for Hepatitis Delta Virus (HDV) infection, nowadays current on development throughout its product or service pipeline, such as prepared 2021 milestones.
Lonafarnib in HDV
- Initial and only oral agent in advancement for HDV
- Period 3 D-LIVR study (N=400) enrollment completion prepared in 2021
- Close of procedure data planned in 2022
Peginterferon Lambda (Lambda) monotherapy in HDV
- Nicely-tolerated interferon for weekly subcutaneous injection
- Period 3 LIMT-2 examine (N=150) planned begin in 2H21
Lambda-Lonafarnib Mix in HDV
- Positive conclude of study Period 2 Lift information introduced at AASLD 2020
- Publication anticipated in 2021
Zokinvy™ for Progeria and Processing-Deficient Progeroid Laminopathies
- U.S. Fda approval in November 2020
- U.S. industrial start prepared in January 2021
- EMA approval expected 2H21
Lambda in COVID-19
- Constructive Section 2 proof of principle facts offered at RespiDART 2020
- Info help affect of baseline viral masses on viral clearance with Lambda
- Pre-IND deal submitted to Fda with advice expected in Q1 2021
- PRV sale for $95M expected to near in January 2021 Eiger will keep 50%
- Pro forma income, dollars equivalents and investments of close to $176M, reflecting $128.8M as of December 31, 2020 as well as $47.5M from PRV sale proceeds predicted in January 2021, envisioned to fund planned functions by means of at the very least Q4 2023
“Our priority in 2021 are our HDV courses, where we strategy to entire D-LIVR enrollment and initiate the Lambda Stage 3 LIMT-2 analyze,” mentioned David Cory, President and CEO of Eiger. “Lonafarnib is the only oral treatment in advancement and Lambda is a effectively-tolerated interferon in improvement for HDV, equally with the potential to turn into foundational chronic therapies with advantage and optionality for clients influenced by this most severe sort of viral hepatitis.”
Eiger is a professional-stage biopharmaceutical organization focused on the progress and commercialization of foundational therapies for Hepatitis Delta Virus (HDV) an infection, the most really serious variety of human viral hepatitis.
Eiger is producing two complementary solutions for HDV. Lonafarnib is a first-in-class, oral prenylation inhibitor in a international Phase 3 trial. Peginterferon lambda is a initial-in-class, nicely-tolerated sort III interferon moving into Section 3.
Zokinvy for the remedy of Hutchinson-Gilford Progeria Syndrome (HGPS or Progeria) and processing-deficient Progeroid Laminopathies is the Firm’s 1st Food and drug administration approval. A Marketing Authorization Application (MAA) is below assessment by the European Medications Agency (EMA). Outside the house the U.S., Eiger’s founded world Managed Obtain Plan, expected to span increased than 40 nations, assures all youngsters and young grownups with Progeria and Progeroid Laminopathies have entry to cure.
For additional facts about Eiger and its clinical systems, please visit www.eigerbio.com.
Observe Regarding Forward-Wanting Statements
This push release consists of “forward-hunting” statements that entail significant hazards and uncertainties. All statements other than statements of historical info, together with statements regarding our long run fiscal issue, timing for and outcomes of clinical success, business tactic and ideas and aims for future operations, are forward-hunting statements. These ahead-seeking statements include terminology these types of as “think,” “will,” “may possibly,” “estimate,” “continue on,” “foresee,” “contemplate,” “intend,” “concentrate on,” “project,” “need to,” “program,” “be expecting,” “predict,” “could,” “likely” or the detrimental of these terms. Forward-on the lookout statements are our existing statements concerning our intentions, beliefs, projections, outlook, analyses or recent expectations about, among the other factors, our anticipating sizeable milestones in 2021, the timing of our ongoing and prepared clinical growth, such as our capability to support the start of a new solution and ship to specialty pharmacies the sufficiency of our funds, money equivalents and investments to fund our functions through at least Q4 2023 the anticipated closing of the sale of our PRV our advancement systems for Zokinvy frequently and the prospective approval of Zokinvy in jurisdictions outdoors of the U.S., including the EU the challenges linked to the commercialization of Zokinvy, our potential to manufacture ample quantities of Zokinvy, and the professional start of Zokinvy in the U.S., the current market probable for Zokinvy as a treatment for Progeria and processing-deficient Progeroid Laminopathies our progression and enrollment of our Section 3 D-LIVR review in HDV our capability to manage source of our professional and scientific demo products our ideas to advance Lambda in HDV in the U.S. and EU our skill to transition into a professional phase biopharmaceutical business our skill to finance the ongoing progression of our improvement pipeline solutions and the probable for achievements of any of our merchandise candidates. These statements concern product candidates that have not yet been authorised for advertising by the U.S. Food stuff and Drug Administration (Fda). No illustration is designed as to their security or success for the purposes for which they are currently being investigated. Various essential factors could bring about genuine results or situations to vary materially from the ahead-hunting statements that Eiger can make, like supplemental applicable threats and uncertainties explained in the “Risk Components” sections in the Quarterly Report on Type 10-Q for the quarter finished September 30, 2020 and Eiger’s subsequent filings with the SEC. The ahead-looking statements contained in this press release are centered on data presently offered to Eiger and converse only as of the date on which they are built. Eiger does not undertake and especially disclaims any obligation to update any forward-wanting statements, whether or not as a final result of any new info, upcoming functions, transformed situation or otherwise.
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