Eiger BioPharmaceuticals Announces First Patient Dosed in Phase 2 ULTRA Study of Ubenimex in Secondary Lymphedema
"Our research has demonstrated that LTB4 is elevated in both preclinical models of lymphedema as well as human lymphedema and that elevated LTB4 is associated with tissue inflammation and impaired lymphatic function," said
"Lymphedema can have long-lasting deleterious effects and can significantly impact quality of life. There is no
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). Approximately forty patients will be randomized in a 1:1 ratio to receive ubenimex or matching placebo, administered orally for a total of 24 weeks. The 24-week study will assess clinical, biomarker, histologic and patient-reported outcomes.
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
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 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, 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 Annual Report on Form 10-K for the period ended
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