Roche Holdings (RHHBY - Free Report) announced disappointing results from a phase II/III study on pipeline candidate, gantenerumab, in patients with a rare inherited form of Alzheimer’s disease (AD).
The phase II/III study, DIAN-TU-001, is sponsored by the Washington University School of Medicine in St. Louis. The study tested two investigational therapies, Roche’s gantenerumab and Eli Lilly’s solanezumab as compared to placebo to determine if either of these treatments could slow down the rate of cognitive decline and improve disease-related biomarkers in people who are known to have a genetic mutation for inherited AD.
The primary outcome measure for the study — the DIAN Multivariate Cognitive Endpoint — is a novel outcome measure designed to assess cognitive performance in patients with autosomal dominant AD (ADAD).
Results showed that the gantenerumab arm of the DIAN-TU-001 study did not meet its primary endpoint as patients did not show a significant slowdown in the rate of cognitive decline.
Additional analyses are ongoing to understand the totality of the data.
However, the results do not impact Roche's two other ongoing phase III studies (GRADUATE 1 and 2) of gantenerumab in patients with the common form of Alzheimer’s disease that is not directly caused by gene mutations (sporadic AD).
Roche’s AD pipeline includes investigational medicines for different targets, types and stages of AD. In addition to the gantenerumab program, Roche is evaluating semorinemab in phase II studies in sporadic AD. Crenezumab also continues to be studied in the Alzheimer’s Prevention Initiative Phase II trial in ADAD, even though two other studies on this candidate were discontinued in people with early (prodromal or mild) sporadic AD.
Roche’s stock has gained 28.8% in the past year compared with the industry’s growth of 13.8%.
We note that developing drugs for AD has been quite challenging for pharma/biotech majors and there have been quite a few failures.
In July 2019, Novartis (NVS - Free Report) and Amgen (AMGN - Free Report) decided to discontinue the investigation of the BACE1 inhibitor, CNP520 (umibecestat), in two pivotal phase II/III studies in the Alzheimer's Prevention Initiative Generation Program.
Nevertheless, Biogen (BIIB - Free Report) is progressing well with its candidate, aducanumab, for AD.
Roche currently carries a Zacks Rank #3 (Hold).You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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