Roche to stop studies of gantenerumab in early Alzheimer's after trials fail
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Roche (OTCQX:RHHBY) (OTCQX:RHHBF) said it would stop studies of its medicine gantenerumab in early Alzheimer's disease after the drug did not meet the main goal of slowing clinical decline in two phase 3 studies in November.
A spokesperson for Roche said in an email statement to Seeking Alpha that, "Based on the GRADUATE topline results, it was clear that gantenerumab was not able to provide sufficient evidence of clinical benefit in people with early Alzheimerâs disease. Given the Phase III GRADUATE results, we stop all of the gantenerumab studies in early Alzheimerâs disease. This includes the GRADUATE I China extension, GRADUATION, Open RoAD and PostGRADUATE open label studies. We expect the same, lower effect in the SKYLINE population, and consider this insufficient to continue."
The spokesperson added that the company will also not start a planned study in historically underrepresented populations with early Alzheimerâs disease, previously announced at the AAIC congress 2022.
The Swiss drugmaker presented full data from the studies GRADUATE 1 and 2 on Wednesday at the Clinical Trials in Alzheimerâs Disease (CTAD) 2022 conference, after having reported initial data from the studies on Nov. 14.
Gantenerumab, which was discovered in collaboration with MorphoSys (MOR), did not show a statistically significant benefit in people with mild cognitive impairment (MCI) due to Alzheimerâs and mild Alzheimerâs dementia.
The drug had showed a reduction in clinical decline of 8% in GRADUATE 1 and 6% in GRADUATE 2 compared with placebo.
Roche noted in a separate emailed statement that, while the company expected to see a 50% lowering of amyloid levels in participants at 2 years, only 28% of people in GRADUATE I and 25% in GRADUATE II reached a centiloid reduction below the positivity threshold at this time point.
The Alzheimer's disease space has been of high stakes but the companies have been eyeing to make their dominance presence felt.
Earlier today, Eli Lilly (LLY) reported data from a phase 3 trial for its Alzheimer's drug donanemab, compared to Biogen (BIIB) and Eisai's (OTCPK:ESALF) (OTCPK:ESALY) Aduhelm. In the study, 37.9% of donanemab-treated participants (25 of 66) achieved brain amyloid plaque clearance, compared to 1.6% of those on Aduhelm (1 of 64).
Donanemab had also reduced brain amyloid levels vs. baseline by 65.2%.
Biogen and Eisai also shared full data from a phase 3 study for a new Alzheimer's candidate called lecanemab.