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
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.
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.
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