Eiger Announces First Patient Dosed in Open-Label Extension of Phase 2 LIBERTY Study of Ubenimex in Pulmonary Arterial Hypertension (PAH)
"The LIBERTY study represents a potentially transformative, clinical translational effort with the goal to demonstrate, for the first time, disease modification in PAH," said
"There has been tremendous enthusiasm in the entire community – patients, families, investigators, and study staff at pulmonary hypertension centers – for the LIBERTY study and a new approach to treating PAH. The extension study shows our commitment to the community by offering an option to receive open-label ubenimex for at least 24 weeks after completing the double-blind study," said
About the LIBERTY Phase 2 Study
LIBERTY is a multi-center, randomized, double-blind, placebo-controlled Phase 2 study of ubenimex in patients with PAH. Approximately forty-five patients will be randomized in a 2:1 ratio to receive ubenimex or matching placebo, administered orally for a total of 24 weeks. Patients who complete treatment through Week 24 may be eligible to enroll in an open-label extension study to receive continued treatment. This open-label extension will allow all patients the option to receive ubenimex for at least 24 weeks and provide additional data on safety, tolerability and efficacy.
About LTB4 and Ubenimex
LTB4 is a naturally-occurring inflammatory mediator shown to be elevated in both animal models of PAH as well as human PAH disease. Published preclinical results of studies conducted at
Ubenimex is a well-characterized, oral, small-molecule, inhibitor of LTA4H, the enzyme responsible for the formation of the pro-inflammatory mediator, LTB4.
Ubenimex is approved in
About PAH
Pulmonary arterial hypertension (PAH) is a type of high blood pressure that affects the arteries in the lungs and the right side of the heart. PAH begins when tiny arteries in the lungs, called pulmonary arterioles, become narrowed, blocked or destroyed. This makes it harder for blood to flow through the lungs, and raises pressure within the lungs' arteries. As the pressure builds, the heart's lower right chamber (right ventricle) must work harder to pump blood through the lungs, eventually causing the heart muscle to weaken and eventually fail. PAH is a progressive, life-threatening illness.
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 identified, and for which an effective therapy is urgently needed. For more information, please visit the Company's website at www.eigerbio.com.
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 potential clinical development outcomes, impact on disease and ability to successfully achieve approval for our clinical candidate ubenimex, 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, including subcutaneous (SC) formulation, may be further developed and approved, whether Phase 2 studies of exendin 9-39 will show safety and activity consistent with early clinical results, including the interim results of the multiple-ascending dose (MAD) study, or that the SC formulation will be consistent with results seen with intravenous (IV) exendin 9-39, 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
Investors:
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/eiger-announces-first-patient-dosed-in-open-label-extension-of-phase-2-liberty-study-of-ubenimex-in-pulmonary-arterial-hypertension-pah-300384526.html
SOURCE