PALO ALTO, Calif., Jan. 7, 2021 /PRNewswire/ — Eiger BioPharmaceuticals, Inc (Nasdaq:EIGR), a professional-phase biopharmaceutical firm targeted on the advancement and commercialization of foundational therapies for Hepatitis Delta Virus (HDV) infection, right now up to date on development across its products pipeline, which include prepared 2021 milestones.
Lonafarnib in HDV
- Very first and only oral agent in progress for HDV
- Stage 3 D-LIVR research (N=400) enrollment completion planned in 2021
- Close of procedure facts prepared in 2022
Peginterferon Lambda (Lambda) monotherapy in HDV
- Well-tolerated interferon for weekly subcutaneous injection
- Section 3 LIMT-2 review (N=150) planned start off in 2H21
Lambda-Lonafarnib Mix in HDV
- Constructive stop of study Section 2 Lift info offered at AASLD 2020
- Publication expected in 2021
Zokinvy™ for Progeria and Processing-Deficient Progeroid Laminopathies
- U.S. Fda acceptance in November 2020
- U.S. professional start prepared in January 2021
- EMA acceptance predicted 2H21
Lambda in COVID-19
- Positive Stage 2 evidence of principle details offered at RespiDART 2020
- Details help impression of baseline viral loads on viral clearance with Lambda
- Pre-IND package deal submitted to Fda with assistance anticipated in Q1 2021
- PRV sale for $95M predicted to close in January 2021 Eiger will keep 50%
- Professional forma money, hard cash equivalents and investments of around $176M, reflecting $128.8M as of December 31, 2020 in addition $47.5M from PRV sale proceeds predicted in January 2021, anticipated to fund planned functions through at least Q4 2023
“Our precedence in 2021 are our HDV courses, where we prepare to total D-LIVR enrollment and initiate the Lambda Stage 3 LIMT-2 review,” stated David Cory, President and CEO of Eiger. “Lonafarnib is the only oral treatment in enhancement and Lambda is a perfectly-tolerated interferon in progress for HDV, both equally with the likely to grow to be foundational persistent solutions with advantage and optionality for clients afflicted by this most really serious kind of viral hepatitis.”
Eiger is a industrial-phase biopharmaceutical company centered on the development and commercialization of foundational therapies for Hepatitis Delta Virus (HDV) an infection, the most serious type of human viral hepatitis.
Eiger is producing two complementary treatment options for HDV. Lonafarnib is a 1st-in-course, oral prenylation inhibitor in a world wide Section 3 trial. Peginterferon lambda is a very first-in-course, perfectly-tolerated sort III interferon entering Section 3.
Zokinvy for the treatment of Hutchinson-Gilford Progeria Syndrome (HGPS or Progeria) and processing-deficient Progeroid Laminopathies is the Firm’s 1st Food and drug administration approval. A Advertising Authorization Application (MAA) is less than evaluation by the European Medications Agency (EMA). Outdoors the U.S., Eiger’s recognized global Managed Obtain Software, predicted to span bigger than 40 international locations, ensures all kids and youthful grownups with Progeria and Progeroid Laminopathies have obtain to procedure.
For additional info about Eiger and its medical packages, be sure to visit www.eigerbio.com.
Observe Pertaining to Ahead-Wanting Statements
This push launch has “forward-looking” statements that entail sizeable hazards and uncertainties. All statements other than statements of historic points, like statements about our long term economical problem, timing for and outcomes of scientific effects, business method and plans and goals for upcoming functions, are forward-searching statements. These forward-hunting statements include things like terminology these types of as “think,” “will,” “may,” “estimate,” “continue,” “anticipate,” “contemplate,” “intend,” “goal,” “project,” “should really,” “program,” “anticipate,” “forecast,” “could,” “potentially” or the adverse of these phrases. Forward-wanting statements are our present statements pertaining to our intentions, beliefs, projections, outlook, analyses or present-day expectations regarding, amid other issues, our anticipating major milestones in 2021, the timing of our ongoing and planned scientific progress, which includes our ability to assistance the start of a new product or service and ship to specialty pharmacies the sufficiency of our dollars, cash equivalents and investments to fund our functions by way of at the very least Q4 2023 the predicted closing of the sale of our PRV our development programs for Zokinvy usually and the opportunity acceptance of Zokinvy in jurisdictions outside of the U.S., such as the EU the pitfalls associated to the commercialization of Zokinvy, our capacity to manufacture adequate portions of Zokinvy, and the commercial start of Zokinvy in the U.S., the industry probable for Zokinvy as a treatment method for Progeria and processing-deficient Progeroid Laminopathies our progression and enrollment of our Stage 3 D-LIVR research in HDV our capability to retain source of our industrial and clinical demo components our ideas to advance Lambda in HDV in the U.S. and EU our ability to changeover into a professional phase biopharmaceutical organization our capability to finance the continued development of our development pipeline solutions and the prospective for results of any of our solution candidates. These statements worry solution candidates that have not nevertheless been authorised for advertising by the U.S. Food and Drug Administration (Food and drug administration). No representation is manufactured as to their security or effectiveness for the applications for which they are becoming investigated. Various critical variables could result in real results or gatherings to differ materially from the ahead-on the lookout statements that Eiger will make, which includes further relevant risks and uncertainties explained in the “Hazard Aspects” sections in the Quarterly Report on Form 10-Q for the quarter ended September 30, 2020 and Eiger’s subsequent filings with the SEC. The forward-hunting statements contained in this push release are dependent on facts at present accessible to Eiger and communicate only as of the date on which they are manufactured. Eiger does not undertake and specifically disclaims any obligation to update any forward-on the lookout statements, whether as a consequence of any new information and facts, foreseeable future situations, transformed instances or in any other case.
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