Teva Pharmaceutical Industries Ltd (ADR) ADR (NYSE:TEVA) has announced that its pipeline asthma treatment has failed to achieve primary endpoints in two late-stage trials.
The company made the announcement on Monday revealing that the two studies involving subcutaneous doses of its pipeline treatment called reslizumab. Teva has been testing the drug for treating patients with elevated blood eosinophils and uncontrolled asthma. The drug has already received regulatory approval for treating patients suffering from severe asthma.
The phase 3 registration study involved the administration of reslizumab (110 mg) using a pre-filled syringe. Unfortunately, the dosage failed to reach the primary endpoint which was to clinically bring down the number of clinical asthma exacerbations (CAEs) in patients suffering from elevated blood eosinophils and uncontrolled asthma.
“We are disappointed that these trials of the reslizumab formulation administered subcutaneously at a fixed-dose of 110 mg did not meet their primary endpoints. However, these results reinforce the role of eosinophils in severe asthma disease biology and the importance of defining the right blood eosinophil cutoff point for patient selection,” stated ushar Shah, Teva’s Senior Vice President of Medical affairs and Specialty Clinical Development.
Shah also added that the company has continued to observe positive performance from the intravenous formulation. It is a 3mg/kg weight-based dosage alternative that is administered to asthma patients that have a high level of blood eosinophils and who do not have proper therapy. There have been no new safety concerns identified during the trial period involving reslizumab based on the data that was collected.
The registration treatment trial involved a priori-powered pre-specified the randomized severe asthma patient population of which 80 percent of the patients with more than 400/mcL baseline blood eosinophil count demonstrated a significant drop in CAE risk. The patient population was also similar to the patient population involved in the Phase 3 clinical trial of the CINQAIR/CINQAERO. Teva revealed that it has continued to see the effects of the treatment using the intravenous formulation.
Teva stock closed the latest trading session on Monday at $21.02 after a 1.55 percent gain compared to the value of the stock during the previous close.