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Phase II/III trials of gantenerumab fail to reach primary endpoint

Author : Saipriya Iyer | Published Date : 2020-02-10 

Genentech, a subsidiary of the Roche group, has recently announced that the Phase II/III DIAN-TU-001 clinical trial for gantenerumab failed to achieve the primary endpoint. The trial of this late-stage investigational medicine was conducted for treatment of patients suffering from early onset and inherited form of AD (Alzheimer’s disease), also known as ADAD (autosomal dominant AD), which accounts for less than 1% of AD cases. The Washington University School of Medicine has sponsored the clinical study.

In the trial, no significant slowdown in the rate of cognitive decline among patients provided with gantenerumab was observed as compared to placebo, measured using the DIAN Multivariate Cognitive Endpoint. The investigational medicine has been maintaining a safety profile consistent with other trials with no new issues being identified.

Roche and Genentech, in collaboration with the Washington University School of Medicine are currently focused on understanding and interpreting the gantenerumab data through additional analyses. In April 2020, the companies are expected to present the collected data at the AAT-AD/PD™ Focus meeting.

The companies’ AD pipelines consist of investigational drugs for various types, targets, and stages of Alzheimer’s disease. Apart from the gantenerumab trials, they are currently examining semorinemab in Phase II trials for sporadic AD. The Alzheimer’s Prevention Initiative Phase II trial in ADAD also includes the study of crenezumab.

Levi Garraway, Global Product Development’s chief medical officer and head, as well as others involved in the clinical study expressed their anticipation of data’s contribution towards understanding the complexities of AD. The study marks the bold undertaking towards treating AD, despite inability to reach primary endpoint. Dr. Garraway also commented on the team’s unwavering confidence in the ongoing Phase III clinical program.

Gantenerumab, is also being studied in GRADUATE 1 and 2, two large global Phase III trials among populations with sporadic AD, which is not caused by gene mutations. ADAD patients in the DIAN-TU-001 trial were initially treated with a lower dose of gantenerumab and started titrating to a 5x higher target dose only around midway through the study period.

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Saipriya Iyer

Saipriya Iyer

Saipriya Iyer presently works as a content developer for fractovia.org. Having dabbled with the domain of content creation for nearly half a decade, she now boasts of an enviable portfolio, holding substantial experience in penning down pieces related to technology, finance, and a wide spectrum of other industry verticals. A qualified computer engineering graduate from the University of Pune, Saipriya can often be found leveraging her knowledge of software technology and electronics in her write-ups. She can be contacted at- [email protected] | https://twitter.com/saipriya_i

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