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News 2017-05-17T13:45:31+00:00
Eiger Announces Results Demonstrating Benefit of Ubenimex and Leukotriene B4 (LTB4) Modulation in Experimental Lymphedema – Data Supports Ongoing Phase 2 ULTRA Study of Ubenimex in Lymphedema

PALO ALTO, Calif., May 17, 2017 — Eiger BioPharmaceuticals, Inc., (NASDAQ: EIGR) today announced publication in Science Translational Medicine (STM) the results of extensive preclinical studies of ubenimex in which modulation of the inflammatory mediator, leukotriene B4 (LTB4), improved experimental lymphedema.  Targeted reduction of LTB4 with ubenimex reversed edema, improved lymphatic function and restored lymphatic architecture in experimental models of lymphedema.  The technology was invented by Stanley Rockson, MD, Professor of Cardiovascular Medicine at Stanford University, which Eiger exclusively licensed in 2015.  Based on these findings, Eiger is conducting ULTRA, a multi-center, Phase 2 clinical study of ubenimex in Secondary Lymphedema, currently enrolling at multiple sites in the U.S. and Australia.

Lymphedema is a state of vascular functional insufficiency in which decreased lymphatic clearance of interstitial fluid leads to edema formation, and progressive, debilitating architectural alterations of the skin and supporting tissues.  Lymphedema typically manifests itself in an arm or leg, but can affect other parts of the body.  Lymphedema often causes long-term physical, psychological, and social problems for patients and significantly impacts quality of life.  There is no approved pharmacologic therapy.

“We have demonstrated for the first time that a naturally-occurring inflammatory substance known as LTB4 is elevated in both animal models of lymphedema as well as human patients with lymphedema and that elevated LTB4 is associated with tissue inflammation and impaired lymphatic function,” said Stanley Rockson, MD, Professor of Cardiovascular Medicine at Stanford University and Lead Investigator for ULTRA.  “Lymphedema is a devastating disorder and an approved pharmacologic therapy is urgently needed.  I believe that LTB4 is a promising drug target for the treatment of lymphedema, and I’m pleased to be the lead investigator for the ULTRA clinical study of ubenimex in secondary lymphedema.  ULTRA will pave the way for investigating ubenimex in other types of lymphedema, including upper extremity and primary lymphedema.”

Tian et al., Sci. Transl. Med. 9, “Leukotriene B4 Antagonism Ameliorates Experimental Lymphedema”, May 10, 2017.

About LTB4 and Ubenimex
Leukotriene B4 (LTB4) is a naturally-occurring inflammatory substance known to be elevated in both preclinical models of secondary lymphedema as well as human lymphedema disease.  Elevated LTB4 causes inflammation resulting in tissue inflammation and impaired lymphatic function.  Targeted pharmacologic inhibition of LTB4 promotes lymphatic repair and reverses lymphedema disease in treated animals.

Ubenimex is a well-characterized, oral, small-molecule, inhibitor of leukotriene A4 hydrolase (LTA4H), the enzyme responsible for the formation of the pro-inflammatory mediator, LTB4.

Ubenimex is approved in Japan (brand name Bestatin™) as an adjunct to chemotherapy agents to extend survival and to maintain remission after treatment for acute non-lymphocytic leukemia in adults.  Ubenimex has been used for over 25 years in Japan and remains commercially available through Nippon Kayaku.  Ubenimex is not approved for any indication in the US or Europe.

About Lymphedema
Lymphedema can be either primary (hereditary) or secondary (caused by another disease or condition).  Primary lymphedema is caused by the absence of certain lymph vessels at birth or abnormalities in the lymphatic vessels and can be divided into three forms, depending on age of onset.  Secondary lymphedema usually develops as a result of a lymph vessel blockage or interruption that alters the flow of lymph through the lymphatic system and can develop from an infection, malignancy, surgery, scar tissue formation, trauma, radiation, or other cancer treatment.  Primary lymphedema and secondary lymphedema are large unmet medical needs, as both can be debilitating and negatively impact quality of life.  There is no approved pharmacologic treatment for lymphedema.

About the ULTRA Phase 2 Study
ULTRA is a multi-center, randomized, double-blind, placebo-controlled Phase 2 study of ubenimex in patients with secondary lymphedema of the lower limb(s).  Up to forty patients may be randomized in a 1:1 ratio to receive ubenimex or matching placebo, administered orally for a total of 24 weeks.  The study will assess clinical, biomarker, histologic and patient-reported outcomes.

About Eiger
Eiger is a clinical-stage biopharmaceutical company committed to bringing to market novel products for the treatment of rare diseases.  The company has built a diverse portfolio of well-characterized product candidates with the potential to address diseases for which the unmet medical need is high, the biology for treatment is clear, and for which an effective therapy is urgently needed.

Note Regarding Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties.  All statements, other than statements of historical facts, included in this press release regarding our strategy, future operations, future financial position, future revenue, projected expenses, prospects, plans and objectives, intentions, beliefs and expectations of management are forward-looking statements.  These forward-looking statements may be accompanied by such words as “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “intend,” “may,” “plan,” “potential,” “project,” “target,” “will” and other words and terms of similar meaning.  Examples of such statements include, but are not limited to, whether or not pegylated interferon lambda-1a or lonafarnib or ubenimex or exendin 9-39 may be further developed and approved, and whether promising earlier clinical study results will be repeated in larger, later clinical studies, statements relating to the availability of cash for Eiger’s future operations, Eiger’s ability to develop its drug candidates for potential commercialization, the timing of the commencement and number and completion of Phase 2 trials and whether the products can be successfully developed or commercialized.  Various important factors could cause actual results or events to differ materially from the forward-looking statements that Eiger makes, including the risks described in the “Risk Factors” sections in the Quarterly Report on Form 10-Q for the three-month period ended March 31, 2017 and other periodic reports filed with the SEC by Eiger.  Eiger does not assume any obligation to update any forward-looking statements, except as required by law.

Eiger BioPharmaceuticals

Source:
Eiger BioPharmaceuticals, Inc.
Investors:
Ingrid Choong, PhD, Eiger BioPharmaceuticals, 650-619-6115,ichoong@eigerbio.com

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Date Title (click to view the full PR) PDF
May 17, 2017 Eiger Announces Results Demonstrating Benefit of Ubenimex and Leukotriene B4 (LTB4) Modulation in Experimental Lymphedema PDF Icon
May 15, 2017 Eiger BioPharmaceuticals Completes Enrollment of Phase 2 LIBERTY Study of Ubenimex in Pulmonary Arterial Hypertension PDF Icon
May 12, 2017 Eiger BioPharmaceuticals Reports First Quarter 2017 Financial Results PDF Icon
May 8, 2017 Eiger Announces Presentation of Prevalence Data of Hepatitis Delta Virus (HDV) Infection in the U.S. at Digestive Disease Week (DDW) in Chicago PDF Icon
May 4, 2017 Eiger BioPharmaceuticals to Host Key Opinion Leader Event Addressing Need for Novel Mechanisms in the Treatment of Pulmonary Arterial Hypertension (PAH) on May 10th in New York City – Phase 2 LIBERTY Study Update for Ubenimex in PAH PDF Icon
May 3, 2017 Eiger Announces U.S. IND Filing of Pegylated Interferon Lambda for Hepatitis Delta Virus Infection – LIMT HDV: Lambda Interferon MonoTherapy in HDV Study Enrolling PDF Icon
April 24, 2017 Eiger Announces Abstract and Presentation at 2017 Digestive Disease Week in Chicago PDF Icon
April 21, 2017 Eiger Announces Additional Phase 2 Clinical Trial Results for Lonafarnib at The International Liver Congress™ 2017 PDF Icon
April 18, 2017 Eiger Announces Industry Veteran Lisa Porter, MD to Lead Development of Exendin 9-39 for the Treatment of Post-Bariatric Hypoglycemia – Novel Liquid Formulation of Exendin 9-39 Advancing PDF Icon
April 6, 2017 Eiger Announces Abstracts and Presentations of LOWR HDV Program at the European Association for the Study of the Liver (EASL) Meeting PDF Icon
March 23, 2017 Eiger BioPharmaceuticals Reports Fourth Quarter and Full Year 2016 Financial Results PDF Icon
January 31, 2017 Eiger BioPharmaceuticals to Present at BIO CEO & Investor Conference February 13th and Participate in SunTrust Robinson Humphrey Orphan Drug Day Conference February 14th PDF Icon
January 3, 2017 Eiger Completes $25 Million Debt Financing with Oxford Finance PDF Icon
January 3, 2017 Eiger Announces First Patient Dosed in Open-Label Extension of Phase 2 LIBERTY Study of Ubenimex in Pulmonary Arterial Hypertension (PAH)— First-in-class inhibitor of LTB4 targeting disease modification in PAH PDF Icon
Date Title (click to view the full PR) PDF
December 12, 2016 Eiger Announces Multiple Advances in Exendin 9-39 Program for the Treatment of Post-Bariatric Hypoglycemia (PBH) – Positive Interim Data from Phase 2 Multiple-Ascending Dose Study – Novel Liquid Formulation of Exendin 9-39 – US Orphan Designation for Hyperinsulinemic Hypoglycemia PDF Icon
November 29, 2016 Eiger Updates Progress in Clinical Development Program for Exendin 9-39 to Treat Post-Bariatric Hypoglycemia (PBH) – Exendin 9-39 investigational new drug (IND) application filed – PBH Analyst / Key Opinion Leader Event planned December 9th – Multiple-ascending dose (MAD) study interim data to be presented PDF Icon
November 14, 2016 Eiger Announces Additional LOWR HDV Program Data, Clinical and Regulatory Plans at the American Association for the Study of Liver Diseases (AASLD) Meeting – Update on Data Presented and Analyst Meeting through Monday Evening PDF Icon
November 14, 2016 Eiger Announces Positive Phase 2 Data at the American Association for the Study of Liver Diseases (AASLD) Meeting: Multiple Paths Forward Identified with Lonafarnib Therapy in LOWR HDV Program – Data Presented through Monday Morning PDF Icon
November 8, 2016 Eiger BioPharmaceuticals Reports Third Quarter 2016 Financial Results PDF Icon
October 24, 2016 Eiger BioPharmaceuticals Launches Nationwide Hepatitis Delta Virus (HDV) Campaign to Expand Awareness and Testing for HDV Infection – Collaboration with ARUP Laboratories and Hepatitis B Foundation – HDV viral load assay now available in U.S. PDF Icon
October 19, 2016 Eiger Announces First Patient Dosed in Phase 2 Study of Pegylated Interferon Lambda in Hepatitis D Virus (HDV) Infection – LIMT HDV: Lambda Interferon MonoTherapy in HDV Study PDF Icon
October 17, 2016 Eiger Announces Orphan Designation of Exendin 9-39 for Treatment of Non-Insulinoma Pancreatogenous Hypoglycemia Syndrome (NIPHS) from European Medicines Agency (EMA) PDF Icon
October 13, 2016 Eiger Announces Abstracts and Presentations of LOWR HDV Program at the American Association for the Study of Liver Diseases (AASLD) Meeting PDF Icon
September 7, 2016 Eiger Announces Completion of Dosing in Phase 2 LOWR HDV – 4 Study at Hannover Medical School PDF Icon
September 6, 2016 Eiger BioPharmaceuticals to Present at the BioCentury NewsMakers in the Biotech Industry Conference on September 9th PDF Icon
September 1, 2016 Eiger BioPharmaceuticals to Present at the 5th Annual Liolios Gateway Conference on September 7, 2016 PDF Icon
August 18, 2016 Eiger BioPharmaceuticals Announces Pricing of Public Offering of Common Stock PDF Icon
August 17, 2016 Eiger BioPharmaceuticals Announces Proposed Public Offering of Common Stock PDF Icon
August 10, 2016 Eiger BioPharmaceuticals Reports Second Quarter 2016 Financial Results PDF Icon
July 28, 2016 Eiger BioPharmaceuticals Announces Partnership with the Hepatitis B Foundation – Raising Awareness of Hepatitis Delta Virus Co-Infection PDF Icon
July 25, 2016 Eiger BioPharmaceuticals Announces First Patient Dosed in Phase 2 ULTRA Study of Ubenimex in Secondary Lymphedema PDF Icon
July 20, 2016 Eiger BioPharmaceuticals Announces Completion of Dosing in Phase 2 LOWR HDV – 3 Study at National Institutes of Health (NIH) PDF Icon
July 18, 2016 Eiger BioPharmaceuticals Announces First Patient Dosed in Phase 2 LIBERTY Study of Ubenimex in Pulmonary Arterial Hypertension PDF Icon
July 6, 2016 Eiger BioPharmaceuticals to Present at the Cantor Fitzgerald 2nd Annual Healthcare Conference on July 12th PDF Icon
June 13, 2016 Eiger Announces Positive Clinical Results of Single Ascending Dose Study of Subcutaneous Exendin (9-39) in Patients with Post-Bariatric Hypoglycemia PDF Icon
June 6, 2016 Eiger to Participate in Jefferies 2016 Healthcare Conference PDF Icon
May 10, 2016 Eiger Announces First Patient Dosed in Phase 2 Multiple Ascending Dose Study of Subcutaneous Exendin (9-39) in Patients with Hypoglycemia Post-Gastric Bypass Surgery PDF Icon
May 3, 2016 Eiger Bio Strengthens Senior Management Team with Announcement of Debra Odink, PhD as Senior Vice President of Technical Operations PDF Icon
April 20, 2016 Eiger BioPharmaceuticals Announces License of Worldwide Rights to Pegylated Interferon Lambda-1a from Bristol-Myers Squibb PDF Icon
April 4, 2016 Eiger BioPharmaceuticals Strengthens Board of Directors with Addition of Industry Veteran Charles J. “Chuck” Bramlage PDF Icon
March 30, 2016 Eiger BioPharmaceuticals Announces Abstracts and Presentations of Lonafarnib Data in Hepatitis Delta at the European Association for the Study of the Liver (EASL) Meeting PDF Icon
March 28, 2016 Eiger BioPharmaceuticals Granted Orphan Medicinal Product Designation for Ubenimex in Pulmonary Arterial Hypertension by European Medicines Agency PDF Icon
March 22, 2016 Eiger BioPharmaceuticals Closes Merger With Celladon Renamed Eiger and New Trading Symbol (NASD: EIGR, as of March 23) Developing a Clinical Stage Pipeline of Orphan Disease Programs PDF Icon
March 22, 2016 Celladon Announces Results of Special Meeting PDF Icon
March 14, 2016 Eiger Announces Completion of Enrollment of Phase 2 LOWR HDV – 4 (LOnafarnib With Ritonavir in Hepatitis Delta Virus – 4) Study at Hannover Medical School PDF Icon
March 9, 2016 ISS and Glass Lewis Recommend Celladon Corporation Shareholders Vote “FOR” Proposed Merger PDF Icon
February 29, 2016 Eiger to Participate in Cowen & Company 2016 Health Care Conference PDF Icon
February 11, 2016 Celladon Sets Date for Special Meeting of Stockholders PDF Icon
January 19, 2016 Eiger BioPharmaceuticals Announces Completion of Enrollment of Phase 2 LOWR HDV – 3 (LOnafarnib With Ritonavir in Hepatitis Delta Virus – 3) Study at National Institutes of Health (NIH) PDF Icon
January 6, 2016 Eiger BioPharmaceuticals Announces First Patient Dosed in Phase 2 LOWR HDV – 4 (LOnafarnib With Ritonavir in Hepatitis Delta Virus – 4) Study at Hannover Medical School in Hannover, Germany PDF Icon
Date Title (click to view the full PR) PDF
December 15, 2015 Eiger BioPharmaceuticals Announces Notice of Allowance for U.S. Patent Covering Bestatin™ (Ubenimex) for the Treatment of Pulmonary Arterial Hypertension PDF Icon
November 30, 2015 Eiger BioPharmaceuticals Granted Orphan Drug Status for Ubenimex in Pulmonary Arterial Hypertension PDF Icon
November 18, 2015 Eiger BioPharmaceuticals and Celladon Corporation Sign Merger Agreement PDF Icon
November 12, 2015 Eiger BioPharmaceuticals Announces Acquisition of Exclusive License to Program for Treatment of Post-Bariatric Hypoglycemia from Stanford University – Clinical Proof of Concept Data Already Generated in Patients PDF Icon
November 11, 2015 Eiger BioPharmaceuticals Announces Acquisition of Exclusive License to Lymphedema Program from Stanford University – Novel Target Identified as Potential Therapeutic Approach for Lymphedema PDF Icon
November 10, 2015 Eiger BioPharmaceuticals Announces Acquisition of Exclusive License to Pulmonary Arterial Hypertension (PAH) Program from Stanford University PDF Icon
November 9, 2015 Eiger BioPharmaceuticals Announces License Agreement with Nippon Kayaku to Develop Bestatin™ (ubenimex) for Inflammatory Diseases Involving LTB4 – First Clinical Target – Pulmonary Arterial Hypertension (PAH) PDF Icon
October 23, 2015 Eiger BioPharmaceuticals Appoints Thomas J. Dietz, Ph.D. to the Eiger Board of Directors PDF Icon
October 20, 2015 Eiger BioPharmaceuticals Appoints Eduardo Martins, M.D., D.Phil., as Senior Vice President, Liver and Infectious Diseases Drug Development PDF Icon
August 17, 2015 Eiger BioPharmaceuticals Announces Key Operational Hires to Senior Management Team: Jim Welch, Chief Financial Officer & Jim Shaffer, Chief Business Officer PDF Icon
July 20, 2015 The Lancet Infectious Diseases Journal Publishes Results of Phase 2 Study of Lonafarnib in Hepatitis Delta Virus (HDV) Infected Patients PDF Icon
April 28, 2015 Eiger BioPharmaceuticals Announces Interim Results of Lonafarnib in Combination with Ritonavir or Pegylated Interferon in Patients Infected with Hepatitis Delta Virus (HDV) PDF Icon
April 20, 2015 FDA Grants Fast Track Designation to Eiger Bio’s Lonafarnib for Hepatitis Delta Virus (HDV) Infection PDF Icon
April 14, 2015 Eiger BioPharmaceuticals Announces Senior Staff Appointments in Clinical Development and Regulatory Affairs: Dr. Joanne Quan, M.D., as Chief Medical Officer & Dr. Shelly Xiong, Ph.D., as Vice President of Regulatory Affairs PDF Icon
April 13, 2015 Eiger BioPharmaceuticals Announces Abstracts and Presentations of Lonafarnib Data in Hepatitis Delta (HDV) at the European Association for the Study of the Liver Conference – April 22 to 26, 2015 PDF Icon
February 23, 2015 Eiger BioPharmaceuticals Announces Presentation of Positive Data in Patients Infected with Hepatitis Delta Virus (HDV) Treated with Lonafarnib – NIH Principal Investigator to Present Abstract and Poster at Conference on Retroviruses and Opportunistic Infections (CROI) PDF Icon