Positive Topline Results for Novel Alzheimer's Drug

Megan Brooks

October 25, 2018

A novel drug is showing promise for helping improve cognition in patients with mild to moderate Alzheimer's disease (AD), according to new topline results.

A phase 3 trial of more than 800 patients showed that those who were randomly assigned to receive oral GV-971 (Green Valley Pharmaceutical Co, China) met the primary endpoint of significant change from baseline to week 36 on the 12-item cognitive subscale of the Alzheimer's Disease Assessment Scale (ADAS-Cog 12) compared with those who received placebo.

"GV-971 is a novel, marine-derived oligosaccharide, which has multi-targeting mechanisms, including inhibition of amyloid-β fibril formation, neuroinflammation, and recondition of dysbiosis of gut microbiota," Meiyu Geng, PhD, Shanghai Institute of Materia Medica, Chinese Academy of Sciences, said in a news release from the manufacturer.

"We are encouraged by our findings from this phase 3 clinical trial," added Geng.

The topline results were released at the 11th Clinical Trials on Alzheimer's Disease Conference in Barcelona, Spain.

Early Effects

In the double-blind, placebo-controlled trial, 818 patients across 34 sites in China were randomly assigned to receive oral GV-971 450 mg twice per day or matching placebo for 36 weeks. Participants (aged 50 to 85 years) met clinical criteria for mild to moderate AD and had scores of 11 to 26 on the Mini–Mental State Examination (MMSE).

Results showed that use of GV-971 was associated with significant improvement (P < .0001) on the primary endpoint. The mean difference between the treatment groups in ADAS-Cog 12 score at 36 weeks was 2.54.

"This statistically significant difference between GV-971 versus placebo was observed as early as week 4 and continued at each follow-up assessment visit," the company reported in their release.

The difference between GV-971 and placebo was also statistically significant in all three subgroups of patients, with MMSE scores ranging from 11 to 14, 15 to 19, and 20 to 26.

The secondary efficacy endpoints included change from baseline to week 36 on the Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC-Plus), the Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL), and the Neuropsychiatric Inventory (NPI).

Results showed a nonsignificant trend for greater improvement on the CIBIC-Plus (P = .059) for those receiving GV-971, but there were no statistically significant differences on the ADCS-ADL or the NPI.

The novel drug was well tolerated by patients; there were no significant group differences in the percentage of patients with adverse or severe adverse events, the company said.

Cautious Optimism?

GV-971 "consistently showed a cognitive benefit" and it has "promise as a new therapy for Alzheimer's disease," Jeffrey Cummings, MD, professor of neurology, Cleveland Clinic Lou Ruvo Center for Brain Health in Ohio, said in the release.

"We look forward to the future global development of GV-971," he added.

However, "additional studies are needed to further clarify and confirm its promising biological and clinical effects," Eric Reiman, MD, executive director of Banner Alzheimer's Institute, Tuscon, Arizona, cautioned in the same release.

Green Valley Pharmaceuticals reported that it has submitted marketing applications to the China drug regulator and plans to conduct global trials in the near future.

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