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|September 08, 2014 8:01 a.m.|
|Successful Completion of Phase III Program for Teva’s Reslizumab Two More Phase Iii Studies Support the Benefits of Reslizumab Treatment in Asthma Patients with Eosinophilia|
New Phase III data presented at
Reslizumab treatment (3.0 mg/kg and 0.3 mg/kg IV injection every four weeks) resulted in significant improvements in lung function versus placebo when administered to patients, with moderate to severe asthma with elevated eosinophils. Improvement was measured by overall change in Forced Expiratory Volume in 1 second (FEV1), a standard measure of the degree of airway obstruction in asthma. Improvements were noted as early as four weeks after initial dose administration and were maintained at the end of the 16 week treatment period. Furthermore, reslizumab produced significant improvements in patient reported asthma control, assessed by using the Asthma Control Questionnaire (ACQ), which includes questions on symptoms, activity limitation, and the use of non-steroidal rescue medication. Improvements in FEV1 and ACQ for the 0.3 mg/kg dose were numerically smaller than for the 3 mg/kgdose.
The majority of reported adverse events (AEs) were mild to moderate and comparable across the treatment groups. The most common AEs in any treatment group were asthma, headache, nasopharyngitis, and upper respiratory tract infection.
"Uncontrolled asthma with eosinophilia is in desperate need of novel
targeted therapies. The key aspects to the success of a treatment for
these patients is the confidence and reduced impact on quality of life
that comes from reduced exacerbations and the sense of normality that
comes with better disease control. Reslizumab fulfills an important
unmet need and has the potential to deliver on both counts," said Dr.
Leif Bjermer, principal investigator of the study and professor of
respiratory medicine and allergology at
Results from a second study, utilizing only the 3 mg/kg dose of reslizumab, in an asthma population that was not selected for elevated blood eosinophils, demonstrated minimal improvements in asthma control, and provides support for the eosinophil threshold of ≥400/µL set for the reslizumab phase III program.
"Teva has conducted an extensive and robust phase III clinical trial
program that has clearly demonstrated the potential utility of
reslizumab for patients who face a very challenging asthmatic condition.
Reduced exacerbation, improved lung function and better asthma control
positions reslizumab as a potential new targeted therapy for patients
with uncontrolled asthma associated with elevated eosinophils,” said Dr.
Teva-Sponsored Data Highlights Include:
The full abstracts can be found at: https://www.ersnetsecure.org/public/prg_congres.entree?ww_i_congres=149
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. Recently announced results from two pivotal Phase III studies demonstrated that reslizumab treatment (3.0 mg/kg IV injection every four weeks) resulted in statistically significant reductions in the frequency of clinical asthma exarcebations compared to placebo (50% and 60% respectively, P<0.0001 for both) with an adverse event profile comparable to placebo.
About the Studies
Study NCT01270464 was a 16-week, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of reslizumab (0.3 or 3.0 mg/kg) as treatment for patients (12-75 years of age, n=311) with eosinophilic asthma.
The primary objective was is to determine whether reslizumab administered once every 4 weeks for a total of 4 doses, is more effective than placebo in improving lung function in patients with eosinophilic asthma.
Study NCT01508936 was a 16-week, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of reslizumab (3.0 mg/kg IV injection every four weeks) treatment in patients (18-65 years of age, n= 492) with moderate to severe asthma.
The primary objective of the study was to assess reslizumab effect on FEV1 in relation to baseline blood eosinophils in subjects with moderate to severe asthma.
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.