BELLUS HEALTH ANNOUNCES PHASE I RESULTS OF PRODRUG NRM8499 INTENDED FOR THE TREATMENT OF ALZHEIMER'S DISEASE

Prodrug demonstrates improved gastrointestinal tolerability and pharmacokinetic profile over tramiprosate

LAVAL, QUEBEC, Jan. 31 /CNW Telbec/ - BELLUS Health Inc. (TSX: BLU) ("BELLUS Health" or the "Company") announced today the results of the phase I clinical study for NRM8499, a prodrug of tramiprosate, intended for the treatment of Alzheimer's disease (the "Phase I Study"). The Phase I Study investigated the safety, tolerability and pharmacokinetic profile of NRM8499 as compared to tramiprosate in a group of 67 young and elderly healthy subjects. Results of the Phase I Study indicated that NRM8499 was safe and well tolerated at the intended therapeutic dose. Moreover, the gastrointestinal tolerability and pharmacokinetic profile of tramiprosate, with regards to the inter-individual variability in drug systemic exposure, were meaningfully improved with NRM8499 when compared to the administration of an equivalent dose of tramiprosate.

"We are pleased with the results of the NRM8499 phase I clinical study," said Roberto Bellini, President and Chief Executive Officer of BELLUS Health. "The results show a solid potential for pursuing NRM8499 for the treatment of Alzheimer's disease."

About the Phase I Study

This randomized, double-blind, placebo-controlled Phase I Study was divided into three parts:

  • Part one, designed as a two-way crossover, compared the safety, tolerability and pharmacokinetic profile of NRM8499 to tramiprosate following a single oral administration in loose-fill capsule in eight young and eight elderly healthy subjects.
  • Part two assessed the safety, tolerability and pharmacokinetic profile of a single oral dose of NRM8499 (300 mg) or placebo administered as a loose-fill capsule in 15 healthy elderly subjects.
  • Part three compared the safety, tolerability and pharmacokinetic profile of NRM8499 in a loose-fill capsule in 36 healthy elderly subjects, to tramiprosate in a loose-fill capsule ("Tramiprosate LF") and a modified-release tablet form of tramiprosate ("Tramiprosate MR"). Subjects were divided into three groups of 12 subjects each who received NRM8499, Tramiprosate LF and Tramiprosate MR, respectively. Single equivalent doses of NRM8499 (172 mg), Tramiprosate LF (100 mg) and Tramiprosate MR (100 mg) were administered.

Safety evaluations conducted during the Phase I Study included reporting of adverse events, clinical laboratory testing, electrocardiogram and monitoring for vital signs. Drug systemic exposure was assessed over 48 hours following the administration of NRM8499, Tramiprosate LF and Tramiprosate MR.

Results showed an improved gastrointestinal tolerability with the prodrug NRM8499 as compared to Tramiprosate LF and Tramiprosate MR. The pharmacokinetic profile of tramiprosate following the administration of the prodrug was also improved in NRM8499 with regards to the inter-individual variability in drug systemic exposure as compared to Tramiprosate LF and Tramiprosate MR.

About NRM8499

NRM8499 is a prodrug of tramiprosate being developed by BELLUS Health for the treatment of Alzheimer's disease. Results from preclinical animal studies showed that NRM8499 provided a better pharmacokinetic profile for tramiprosate in plasma and the brain when compared to the administration of tramiprosate alone. The Company believes that an improved pharmacokinetic profile and better gastrointestinal tolerability may help improve the therapeutic effect on cognitive function and other clinical outcomes in Alzheimer's disease. 

About BELLUS Health

BELLUS Health is a development-focused health company concentrating on research and development of products that provide innovative health solutions and address critical unmet medical needs. For further information, please visit www.bellushealth.com.

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.

For further information:


Anne-Marie Durand
514-843-2319
amdurand@national.ca

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BELLUS HEALTH INC.

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