With the FDA decision on Biogen's Aducanumab | IONS Message Board Posts

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Msg  61599 of 61606  at  6/14/2021 12:18:43 AM  by


 In response to msg 61597 by  Mabel
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Re: With the FDA decision on Biogen's Aducanumab

Not sure theres a reason to move forward with Tominersen based on the Phase 3 analysis.


From the article:

What the iDMC analysis found

In their analysis, iDMC members specifically looked at data covering patients in the GENERATION HD1 study for 69 weeks (about a year-and-a-half). This included approximately 60% of participants in each of the three study groups.

Among participants given placebo, scores on the cUHDRS as well as scores on its individual measures of functionality, mobility, and cognition tended to worsen over time. That is expected in a progressive disease like Huntingtons, where symptoms usually become worse as time goes on.

Among participants given the less-frequent dosing of tominersen (every 16 weeks), scores on the cUHDRS and its individual measures were generally comparable to placebo at all timepoints. There was no evidence that the active treatment was easing symptoms or improving participants ability to function, relative to the placebo.

For those given tominersen every eight weeks, cUHDRS and related scores worsen over time more quickly than they did for participants given placebo. By 69 weeks of treatment, individuals given this more frequent dosage of tominersen consistently had worse scores than those given placebo or tominersen once every 16 weeks.

The same trend was found for the Montreal Cognitive Assessment (another measure of cognition not included in the cUHDRS) and for clinician-rated assessments.

Collectively, these data illustrate, a very consistent pattern that weve observed across these multiple measures. We do not see any benefit or favorable outcome for tominersen treatment versus placebo, Boak said.

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Msg # Subject Author Recs Date Posted
61600 Re: With the FDA decision on Biogen's Aducanumab aaljack 0 6/14/2021 3:41:19 PM

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