Tramiprosate North American Phase III Clinical Study Results
Published in Journal of Nutrition, Health and Aging
LAVAL, QC, July 6 /CNW Telbec/ - BELLUS Health Inc. (TSX: BLU) announces that the Journal of Nutrition, Health and Aging, the journal of the European Union Geriatric Medicine Society, has published results showing that tramiprosate (homotaurine) slows the loss of volume in the hippocampus, a region of the brain associated with memory. These analyses also suggest that tramiprosate (homotaurine) has a beneficial effect on cognition. These analyses were conducted on a subgroup of 312 patients that underwent Magnetic Resonance Imaging (MRI) of the brain in the North American Phase III clinical trial for tramiprosate for Alzheimer's disease (AD).
The Journal of Nutrition, Health and Aging is a peer-reviewed journal whose aim is to contribute to the improvement of knowledge regarding the relationships between nutrition and the aging process from birth to old age. The article entitled, "Effect of Tramiprosate in Patients with Mild-to-Moderate Alzheimer's Disease: Exploratory Analyses of the MRI Sub-group of the Alphase Study," was published in the n 6, June 2009 issue of the journal. An online version of the publication will be available at http://www.springerlink.com/content/1760-4788 in the next few days.
The efficacy, safety and disease-modification of tramiprosate (homotaurine) was investigated in a large-scale multi-center, double-blind, randomized, placebo-controlled Phase III clinical study in 1,052 patients with mild-to-moderate AD. A subset of 508 patients underwent volumetric MRI measurements. Of these, 312 completed the 78-week trial and provided paired scans of their hippocampus volume changes at study entry and final visits, and were included in these analyses. Patients were randomized to receive placebo BID, tramiprosate 100 mg BID, or tramiprosate 150 mg BID for 78 weeks. Multi-variable statistical models using accepted methods for covariate selection were developed to assess the treatment effect on standardized Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog) and Clinical Dementia Rating-Sum-of-boxes (CDR-SB) assessments.
Results
The analyses describe the hippocampal volume change and cognitive and clinical results in this subgroup of 312 patients. While study design issues and the complexity of the nature of the disease and its progression must be considered taken together, the imaging and cognitive analyses in this subgroup are consistent with the hypothesis that tramiprosate (homotaurine) reduces the atrophy of the hippocampus over 78 weeks of treatment and reduces the rate of cognitive decline while revealing a benign safety profile.
- Analysis on cognition using ADAS-cog scores showed less decline from baseline to each visit in tramiprosate-treated patients relative to placebo, including statistically significant differences in favor of the tramiprosate 150 mg BID group at the 26- and 52-week time points. - With respect to the hippocampal volume changes, the analysis showed dose-dependent and statistically significant lower reduction of hippocampus volume in the tramiprosate 100 mg BID (68%) and 150 mg BID (no loss) groups, when compared to placebo. - Slope analyses of ADAS-cog score changes showed significant differences in favor of the 150 mg BID group, and when both active groups were combined, in comparison to the placebo group. - No between-group differences with respect to changes to each visit in the CDR-SB were observed with either modeling approach.
"BELLUS Health's accumulated knowledge generated by the tramiprosate Phase III clinical trials and the experience it has gained in developing tramiprosate is invaluable to the field of neurology. The publication of this work by a peer-reviewed journal is testimony of its credibility and importance," said Dr. John Sampalis, Acting Chief Science Officer of BELLUS Health, Professor of Medicine and Surgery at McGill University, and President of JSS Medical Research. "These results support the development of tramiprosate-based treatments for Alzheimer's disease," he concluded.
Safety Results
Tramiprosate (homotaurine) was generally safe and well tolerated. The incidence of serious adverse events reported in patients treated with tramiprosate (homotaurine) was comparable to the incidence for patients in the placebo group. The most common adverse events reported slightly more frequently for tramiprosate (homotaurine) than placebo were nausea, fainting, dizziness, and body weight decrease.
NRM8499
Based on these revealing results, BELLUS Health is advancing the development of its tramiprosate prodrug candidate, NRM8499.
With respect to the clinical development of NRM8499, BELLUS Health is forging ahead with the NRM8499 Phase I study this year, and expects to initiate a Phase II study next year. When compared to the parent compound, NRM8499 exhibits an increase in brain and plasma exposure. Patent protection for NRM8499 will extend to 2030.
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