June 30, 2008
Teva and ANP’s Phase IIa Multiple Sclerosis Drug Meets Study End Point
Teva Pharmaceutical Industries and Antisense Therapeutics have announced that ATL/TV1102, a novel, anti-sense drug, significantly reduced disease activity in patients with relapsing-remitting multiple sclerosis.
ATL/TV1102 Phase IIa trial was a randomized, double-blind, placebo-controlled clinical trial of ATL/TV1102. The goal of the trial was to obtain preliminary evidence of ATL/TV1102's effectiveness in reducing multiple sclerosis (MS)-related magnetic resonance images (MRI) brain lesions and assess its safety profile.
In the primary endpoint of the study, ATL/TV1102 showed a significant 54.4% reduction in cumulative number of new active MRI lesions on weeks four, eight and 12 (p=0.01). In addition, patients taking ATL/TV1102 experienced a 65% reduced cumulative number of Gadolinium (Gd)-enhancing lesions on weeks four, eight and 12 (p=0.0053). ATL/TV1102 was also effective in significantly reducing T1-enhancing lesion volume by 84% at week 12. Data from this study demonstrated that in general, ATL/TV1102 was well-tolerated.
Based on these encouraging results, Teva intends to conduct additional pre-clinical and clinical research before continuing to a Phase III study with this unique and promising molecule. This decision by Teva to move forward with the development of ATL/TV1102 triggers a $4 million milestone payment in accordance with the license agreement between Teva and Antisense Therapeutics (ANP).