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Announcing new Phase II clinical study, GENERATION HD 2


ANNOUNCING GENERATION HD2 – 21 September 2022

Dear HD community,

We are pleased to share that Roche and Genentech have announced plans for a new Phase II clinical study, GENERATION HD2.

This study will evaluate the safety, biomarkers and efficacy of tominersen in people aged 25 to 50 with prodromal (very early, subtle signs of Huntington disease [HD]) or early manifest HD. This study follows GENERATION HD1, a previously conducted Phase III trial that tested two different doses of tominersen in adults with manifest HD. That trial was stopped in March 2021 following the evaluation of the overall benefits and risks of study participants.

An analysis done on the data available to Roche suggests that a lower exposure to the drug may benefit younger adult patients with earlier stages of HD. The new Phase II GENERATION HD2 study aims to assess lower doses of tominersen in these younger adults at an earlier stage of HD than those involved in the previous trial.

We expect study participant enrollment to begin early next year, and information will be shared with you as the planning continues and more details become available.

Sincerely,

Shelly Redman


 

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