LAVAL, QC, April 1 /CNW Telbec/ - BELLUS Health Inc. (TSX: BLU) ("BELLUS Health" or the "Company") announced today that, on March 30, 2010, the Company initiated a Phase I clinical study for NRM8499, a prodrug of tramiprosate. NRM8499 is intended for the treatment of Alzheimer's disease. The randomized, double-blind, placebo-controlled study will investigate the safety, tolerability and pharmacokinetic profile of NRM8499 in a group of up to 84 young and elderly healthy subjects.
NRM8499 was previously identified by BELLUS Health as a compound which increases the brain exposure to tramiprosate. Preclinical studies conducted in rodents showed that NRM8499 increased plasma and brain exposure to tramiprosate by 1.5 to 3 fold. The Company believes that an increase in the exposure of tramiprosate to the brain may help improve the therapeutic effect on cognitive function and other clinical outcomes in Alzheimer's disease.
"We are very excited about the launch of the NRM8499 Phase I clinical study. The knowledge acquired through the tramiprosate development program concerning this compound, along with our enhanced understanding of Alzheimer's disease acquired through more than 15 years of preclinical and clinical research in this field, leads us to believe that the potential for NRM8499 is extremely promising," said Roberto Bellini, President and Chief Executive Officer of BELLUS Health. "We are looking forward to the results of the study which could eventually lead to the development of the first disease-modifying treatment for Alzheimer's disease," he concluded.
Entitled "A Phase I, Single-Center, Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Investigate the Safety, Tolerability and Pharmacokinetics of NRM8499 Administered as Single and Multiple Oral Doses to Healthy Young Males and Healthy Elderly Male and Female Subjects", the study will be divided in four parts:
- The first part will compare the safety, tolerability and
pharmacokinetic of NRM8499 following a single oral administration in
both young and elderly healthy subjects, to those of tramiprosate in
the same conditions.
- The second part will assess the safety, tolerability and
pharmacokinetic of up to four single ascending oral doses of NRM8499 in
healthy elderly subjects.
- The third part will investigate the effect of food on the safety,
tolerability and pharmacokinetics of NRM8499 following a single oral
administration in healthy elderly subjects.
- Finally, the fourth part of the study will evaluate the safety,
tolerability and pharmacokinetic profile of up to three multiple
ascending oral doses of NRM8499 in healthy elderly subjects.
NRM8499 has shown a benign safety profile in preclinical toxicity studies. The NRM8499 Phase I clinical study is expected to conclude in the second half of 2010.
About BELLUS Health
BELLUS Health is a global health company focused on the research and development of products to provide innovative health solutions to address critical unmet medical needs.
Forward Looking Statements
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.
SOURCE BELLUS Health Inc.
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