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Teva Pharmaceutical Industries: Teva Presents New Data For Sd-809 In Huntington Disease At 68

The following excerpt is from the company's SEC filing.

American Academy of

Neurology (AAN) Annual Meeting in Vancouver, B.C.

First-HD Study shows improvements in Total Motor Score and Swallowing Function in Huntington

disease patients treated with SD-809

Jerusalem, April 18, 2016

Teva Pharmaceutical Industries Ltd., (NYSE and TASE: TEVA) today announced new data from the Phase III placebo-controlled and randomized

Time Use of SD-809 in

untington

isease (First-HD) study evaluating the efficacy, safety and tolerability of SD-809 (deutetrabenazine) for the treatment of chorea associated with Huntington dise ase (HD). The data will be featured during two Platform Sessions at the 68

American Academy of Neurology (AAN) meeting in Vancouver, B.C.

With limited options for patients living with Huntington disease, there is a great need for therapies, said Michael Hayden, MD, PhD, President of Global R&D and Chief Scientific Officer at Teva. We are proud to present this data as part of Tevas commitment to research in HD.

A total of 90 patients were enrolled in the First-HD study for evaluation over 13 weeks. Patients underwent dose titration over the initial 8 weeks of treatment followed by 4 weeks of maintenance therapy. The overall treatment period was 12 weeks, followed by a 1-week washout period. The Phase III First-HD study data showed that deutetrabenazine improved chorea. The most common adverse reactions reported (5% and greater than placebo) were: somnolence, dry mouth, diarrhea, insomnia, and fatigue.

Platform Session details follow:

Presentation: Rating Swallowing Function in Patients with Huntington Disease Enrolled in the First-HD Study

Monday, April 18, 2016; 4:45 to 5:00 p.m. PST

In the Phase III First-HD study, data showed deutetrabenazine significantly improved swallowing as measured by the Swallowing Disturbance Questionnaire (SDQ).

Presentation: Deutetrabenazine Effect on Total Motor Score in Patients with Huntington Disease (First-HD)

Tuesday, April 19, 2016; 8:15 to 8:30 a.m. PST

This additional data set shows significant improvement in total motor score (TMS) with contributions from improved dystonia.

About Huntington Disease

Huntington disease (HD) is a fatal neurodegenerative disease characterized by uncoordinated and uncontrollable movements, cognitive deterioration and behavioral and/or psychological problems. Onset of HD symptoms typically occurs in middle age, but the disease also manifests in children and the elderly. HD is the most common genetic cause of abnormal involuntary writhing movements called chorea.

About SD-809

SD-809 (deutetrabenazine) is an investigational, oral, small-molecule inhibitor of vesicular monoamine 2 transporter, or VMAT2, that is being developed for the treatment of chorea associated with Huntington disease (HD). Deutetrabenazine has been granted Orphan Drug Designation for the treatment of HD by the U.S. Food and Drug Administration (FDA)...


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