HD Clinical Trials

Community Statement From Roche Regarding Clinical Trial on Tominersen Drug

Author Therese Crutcher-Marin

Unfortunately, I have to share sad news on the promising clinical trial on the drug Tominersen.

This statement is from Roche/Genentech on March 22, 2021.  From David West, on behalf of the Roche/Genentech HD team Senior Director, Global Patient Partnership

Dear global HD partners,

As part of our ongoing partnership and following your request to receive important and timely updates about Roche’s HD clinical programme, we wanted to share an important update with you. 

We have tough news to share, and we recognise that it will be even more difficult to receive.

Throughout the Phase III GENERATION HD1 study of tominersen in manifest Huntington’s disease (HD), an independent data monitoring committee (iDMC) has been in place. This committee is separate from Roche and Genentech and regularly reviews incoming clinical study data (that Roche and Genentech do not have access to) to review patient safety and assess the balance of potential risk versus potential benefit for study participants. The committee recently met for a pre-planned review of the latest safety and efficacy data from GENERATION HD1 and made a recommendation about the investigational therapy’s potential benefit/risk profile. Based on the committee’s recommendation, we will permanently stop dosing with tominersen and placebo in the GENERATION HD1 study. It is important to note that the recommendation is not based on any new emergent safety concern, but on a broad assessment of the benefit/risk of the treatment arms compared to the placebo arm over time.

Unfortunately, whilst this will raise questions in the community, we do not yet have access to the data from this study. What we can share with you at this time is provided in this letter and in our press release. Please find our press release here.

To read the full press release, visit:  https://hdsa.org/wp-content/uploads/2021/03/Tominersen-programme-update-Community-letter.pdf

or on https://en.hdbuzz.net/

HDSA had a webinar this morning explaining the “why” of stopping the clinical trial.  The recording will be available in a few days

REMEMBER, We Can Never Lose HOPE……

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