Teva Late-stage Trial Of Asthma Treatment Fails To Meet Primary Endpoint

(RTTNews) - Teva Pharmaceutical Industries Ltd. (TEVA) said Monday that a Phase III registration study evaluating subcutaneously administered reslizumab (110 mg) in a pre-filled syringe did not meet its primary endpoint of significantly reducing the frequency of clinical asthma exacerbations or CAEs in patients with uncontrolled asthma and elevated blood eosinophils >300/mcL.

A Phase III claim-support study evaluating subcutaneously administered reslizumab in patients with oral corticosteroid or OCS-dependent asthma did not meet its primary endpoint of reduction in daily OCS dose.

In the pre-market trade, TEVA is trading at $20.30, down $0.40 or 1.93%.

In the registration study, a pre-specified a priori-powered subgroup analysis of 80% of the total randomized severe asthma patient population with baseline blood eosinophil count of = 400/mcL showed significant reduction in CAE risk (p <0.025).

The patient population is similar to those studied in the Phase III clinical trials for CINQAIR/CINQAERO (reslizumab) injection, the currently approved intravenous formulation, which also used a blood eosinophil count of = 400/mcL.

Teva said no new safety concerns to the known safety profile of reslizumab were identified in review of the data from these studies and no cases of anaphylaxis related to reslizumab were reported.