BELLUS Health Announces Exploratory Results in Peer-Reviewed Publication Reveal Tramiprosate Slows Atrophy of Brain Hippocampus with Preliminary Evidence of Beneficial Effect on Cognition
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.
About BELLUS Health
BELLUS Health is a global health company focused on the development and
commercialization of products to provide innovative health solutions to
address critical unmet needs.
To Contact BELLUS Health
For additional information on BELLUS Health and its drug development
programs, please call the Canada and United States toll-free number
1-877-680-4500 or visit the Web Site at www.bellushealth.com.
Certain statements contained in this news release, other than statements
of fact that are independently verifiable at the date hereof, may constitute
forward-looking statements. Such statements, based as they are on the current
expectations of management, inherently involve numerous risks and
uncertainties, known and unknown, many of which are beyond BELLUS Health
Inc.'s control. Such risks include but are not limited to: the impact of
general economic conditions, general conditions in the pharmaceutical and/or
nutraceutical industry, changes in the regulatory environment in the
jurisdictions in which the BELLUS Health Group does business, stock market
volatility, fluctuations in costs, and changes to the competitive environment
due to consolidation, that actual results may vary once the final and
quality-controlled verification of data and analyses has been completed, as
well as other risks disclosed in public filings of BELLUS Health Inc.
Consequently, actual future results may differ materially from the anticipated
results expressed in the forward-looking statements. The reader should not
place undue reliance, if any, on any forward-looking statements included in
this news release. These statements speak only as of the date made and BELLUS
Health Inc. is under no obligation and disavows any intention to update or
revise such statements as a result of any event, circumstances or otherwise,
unless required by applicable legislation or regulation. Please see the Annual
Information Form of BELLUS Health Inc. for further risk factors that might
affect the BELLUS Health Group and its business.
For further information: Michelle Stein, Specialist, Corporate Communications, (450) 680-4573, mstein@bellushealth.com
Index of Releases