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|September 02, 2014 8:01 a.m.|
|Teva’s Reslizumab Delivers Clinically and Statistically Significant Reduction in Asthma Exacerbations in Two Pivotal Phase III Studies|
In both trials, reslizumab treatment showed both clinically relevant and
statistically significant reductions in the frequency of CAE compared to
placebo (50% and 60% respectively, p <0.0001 for both). Reslizumab has
also demonstrated a positive effect on lung function and asthma control
in the Phase III program (data to be presented at the
“The consistent results from these duplicate Phase III trials
demonstrating substantial reductions in asthma exacerbations are
impressive,” said Professor
This initial set of results shows the adverse event profile of reslizumab was comparable to placebo in both trials. The incidence of common AEs (> 5%) was consistent with those seen in a moderate to severe asthma population, the most frequent being upper respiratory tract infections, asthma and headache. Further analyses of additional efficacy and safety data are ongoing.
"These pivotal Phase III study results are striking. Asthma that is
inadequately controlled by current standard of care therapy continues to
present a serious problem for patients, physicians and healthcare
systems. The success of these studies gives us confidence that we may
have a valuable potential new treatment option for asthma patients, with
elevated levels of blood eosinophils, who are at risk of exacerbation,"
The results announced today provide a strong foundation for investigation of additional indications, such as COPD with elevated eosinophils. The ongoing development of a subcutaneous formulation will further strengthen the franchise and is expected to be submitted for approval in the second half of 2017.
These new data are from two global Phase III 12-month, randomized, double-blind, placebo-controlled, parallel-group studies, evaluating the efficacy and safety of intravenously administered reslizumab (3.0 mg/kg) once every four weeks, compared to placebo in asthma patients (12-75 years of age with elevated blood eosinophils) that are inadequately controlled by standard of care therapy.
The two pivotal Phase III studies involved 953 patients across 232 medical centers worldwide including the US, EU and the Far East. These studies are part of the Phase III BREATH program that evaluated the safety and efficacy of reslizumab treatment in four separate Phase III trials involving more than 1700 adolescent and adult asthma patients with elevated eosinophils, whose symptoms were inadequately controlled with inhaled corticosteroids with or without another controller medication.
Increased levels of blood eosinophils have been shown to correlate with
future risk and severity of asthma exacerbations. IL-5 is an important
element in the growth and activity of eosinophils and blocking its
activity has now been shown to reduce asthma exacerbation. Uncontrolled
asthma, associated with elevated eosinophils, impacts a large number of
patients. It is a major challenge for both clinicians and patients and
constitutes a significant burden on healthcare systems: It is estimated
that the market for severe asthma biotech drugs could exceed
Detailed analyses of the data are ongoing and full results will be submitted for presentation to a future scientific meeting and for publication in a peer reviewed journal.
Reslizumab is an investigational humanized monoclonal antibody (mAb) against interleukin-5 (IL-5). IL-5 has been shown to play a crucial role in the maturation, growth and chemotaxis (movement) of eosinophils, inflammatory white blood cells implicated in a number of allergic diseases.
About the Studies
was a Phase III, 12-month, multicenter, randomized, double-blind,
placebo-controlled study designed to evaluate the efficacy, safety, and
immunogenicity of treatment with reslizumab in 489 patients with
eosinophilic asthma. Its primary objective was to demonstrate the
efficacy of reslizumab, at a dose of 3 mg/kg administered IV every 4
weeks, as assessed by the reduction in frequency of clinical asthma
exacerbations (CAEs). Principal investigator – Professor
Study was conducted in 128 study centers including -
Study NCT01285323 was a Phase III, 12-month, double-blind,
placebo-controlled, parallel-group study to evaluate the efficacy and
safety of reslizumab treatment (3 mg/kg administered IV every 4 weeks)
in the reduction of clinical asthma exacerbations in 464 patients (12-75
years of age) with eosinophilic asthma whose symptoms are inadequately
controlled with inhaled corticosteroids. Principal investigator – Dr.
Study was conducted in 104 study centers including -
Asthma is a common, chronic inflammatory condition that affects approximately 12% of adults and 10% of children and adolescents; it is estimated that 300 million people worldwide suffer from this condition. Patients with inadequately controlled severe persistent asthma are at risk of exacerbations, hospitalization and death, and often have impaired quality of life.
Safe Harbor Statement under the U.S. Private Securities Litigation Reform Act of 1995:
This release contains forward-looking statements, which are based on
management’s current beliefs and expectations and involve a number of
known and unknown risks and uncertainties that could cause our future
results, performance or achievements to differ significantly from the
results, performance or achievements expressed or implied by such
forward-looking statements. Important factors that could cause or
contribute to such differences include risks relating to: our ability to
develop and commercialize reslizumab, as there can be no certainty as to
its application timing, approval, final product profile or market
penetration; competition for our innovative products, especially
COPAXONE® (including competition from orally-administered alternatives,
as well as from potential purported generic equivalents); the
possibility of material fines, penalties and other sanctions and other
adverse consequences arising out of our ongoing FCPA investigations and
related matters; our ability to achieve expected results from the
research and development efforts invested in our pipeline of specialty
and other products; our ability to reduce operating expenses to the
extent and during the timeframe intended by our cost reduction program;
our ability to identify and successfully bid for suitable acquisition
targets or licensing opportunities, or to consummate and integrate
acquisitions; the extent to which any manufacturing or quality control
problems damage our reputation for quality production and require costly
remediation; our potential exposure to product liability claims that are
not covered by insurance; increased government scrutiny in both the U.S.
Teva Pharmaceutical Industries Ltd.