PALO ALTO, Calif. – May 4, 2017 – Eiger BioPharmaceuticals, Inc. (Nasdaq:EIGR), focused on the development and commercialization of targeted therapies for rare diseases, will host a key opinion leader lunch to address the need for novel mechanisms in the treatment of pulmonary arterial hypertension (PAH), promising preclinical research identifying the potential for disease modification in PAH, and new classes of investigational therapies now in the clinic. The event will be held at the Lotte New York Palace Hotel in New York City on Wednesday, May 10th from 12:00pm to 1:30pm Eastern Time.
The meeting will feature presentations by key opinion leaders Mark Nicolls, MD (Stanford University) and Roham Zamanian, MD (Vera Moulton Wall Center for Pulmonary Vascular Disease, Stanford University), who will discuss the contribution of autoimmunity and inflammation in PAH, the inflammatory role of leukotriene B4 (LTB4), and the potential for disease modification in PAH. New targets and approaches in development for the treatment of PAH will also be discussed. Both KOLs will be available to answer questions following the lunch.
Eiger management will provide an update on enrollment in the Phase 2 LIBERTY study of ubenimex for the treatment of PAH and announce timelines and plans for topline data.
“Inflammation is now recognized as an important component of PAH which is not addressed by currently available therapies,” said Mark Nicolls, MD, Chief of Pulmonary and Critical Care Medicine at Stanford University School of Medicine. “Our recently published preclinical studies suggest that elevated LTB4 levels may play a role in the inflammatory component of PAH, which can lead to obstructed arterioles, vasoconstriction, and worsening cardiac function. Targeted LTB4 blockade may represent an important new therapeutic approach to PAH disease.”
“The LIBERTY study represents a clinical translational effort with potential for disease modification in PAH,” said Roham Zamanian, MD, Lead Investigator and Director of the Adult Pulmonary Hypertension Program at Stanford University School of Medicine. “While currently approved vasoactive agents have utility in the clinical management of the symptoms of PAH, they do not address the underlying inflammation which is an important signature of this cardiovascular disease. We have arrived at a moment of shift of therapeutic paradigm, where we may have a chance to realize a potentially disease modifying approach.”
About the Speakers
Dr. Mark Nicolls is a practicing pulmonologist and investigator, and the Chief of the Division of Pulmonary and Critical Care Medicine at Stanford as well as the Director of Lung Immunology. He holds an endowed Chair of Medicine (The Stanford Chair of Pulmonary and Critical Care Medicine), is an elected member of the American Society for Clinical Investigation (ASCI), and is a permanent standing member on the NIH study section RIBT (Respiratory Integrative Biology and Translational Research Study Section). He is an NIH-funded investigator whose laboratory focuses on the contribution of immunity in vascular injury in pulmonary hypertension, lung transplantation and lymphedema. Dr. Nicolls leads the first NIH trial of immunotherapy as a treatment for pulmonary arterial hypertension (PAH).
Dr. Roham Zamanian is Associate Professor of Medicine in the Division of Pulmonary and Critical Care Medicine, Director of the Adult Pulmonary Hypertension Program at Stanford University School of Medicine, and a faculty member of the Vera Moulton Wall Center for Pulmonary Vascular Disease. He has been the Director of the Adult Pulmonary Hypertension (PH) Program since 2007. The Stanford Adult Pulmonary Hypertension Program evaluates and treats approximately 600-700 PH patients annually. Besides an active clinical career, Dr. Zamanian is extensively engaged in clinical translational research. He directs the Vera Moulton Wall Center clinical database and biobank and focuses his research on clinical characterization and impact of novel risk factors such as methamphetamine use, and biomarkers, such as insulin resistance, in PAH. Dr. Zamanian has re-focused the research mission of the Stanford PH program by collaborating with basic science faculty and implementing several proof-of-concept and phase II clinical trials of novel therapeutics developed at Stanford University.
This event is intended for institutional investors, sell-side analysts, investment bankers, and business development professionals only. Please RSVP in advance if you plan to attend, as space is limited. To reserve a spot, please contact LifeSci Advisors, LLC at Mac@LifeSciAdvisors.com.
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. Patients are 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 are 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 additional 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 Stanford University suggest that elevated LTB4 levels may play a role in the inflammatory component of PAH, which can lead to obstructed arterioles, vasoconstriction, and worsening cardiac function. Targeted LTB4 blockade may represent an important new therapeutic approach to this disease.
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 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 has been granted Orphan Drug Designation for treatment of PAH by the US FDA and European Medicines Agency (EMA). Ubenimex is not approved for any indication in the US or Europe.
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.
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. For additional information about Eiger and its clinical programs, please visit 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 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 Annual Report on Form 10-K for the period ended December 31, 2016 and Eiger’s periodic reports filed with the SEC. Eiger does not assume any obligation to update any forward-looking statements, except as required by law.
Ingrid Choong, PhD, Eiger BioPharmaceuticals, 650-619-6115, firstname.lastname@example.org