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TRADING SYMBOL: MBI (TSE/CDNX)
MGIXF (US over the counter)
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Investor Relations Contacts:
Art Ayres
Micrologix Biotech Inc.
Telephone: 604.221.9666
Toll-Free: 1.800.665.1968
aayres@mbiotech.com
Website
www.mbiotech.com
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Marla Gale
Fleishman-Hillard Canada Inc.
Telephone: 416.214.0701
Fax: 416.214.0720
galem@fleishman.com
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Micrologix Announces Results of Phase Ib Trial for MBI 853NL
Releases New Anti-Inflammatory Data Promising for Acne
Program
Vancouver, CANADA, July 16, 2001 –
Micrologix Biotech Inc. today announced that based on the analysis of data
from the Phase Ib trial of MBI 853NL for preventing hospital-acquired
Staphylococcus aureus (S. aureus) infections and projected future clinical
trial requirements, the Company has decided not to proceed to a Phase II
efficacy study. Micrologix will instead focus its resources on other products
in its pipeline, including two more clinically advanced and promising
products: MBI 594AN for the treatment of acne (Phase II) and MBI 226 for the
treatment of catheter-related bloodstream infections (Phase III). Micrologix
also announced new preclinical data that shows significant anti-inflammatory
activity for its peptides, which further supports MBI 594AN in the treatment
of acne.
MBI 853NL Phase Ib Results
The Phase Ib trial was a randomized, double-blind, placebo-controlled study
to assess the safety and tolerability of MBI 853NL applied intranasally
to healthy volunteers who were persistent carriers of nasal S. aureus. Data
from the study found that MBI 853NL was safe, well tolerated and resulted in a
decreased number of S. aureus organisms in all MBI 853NL-treated groups.
"While the suspension of the MBI 853NL program comes as a
disappointment, the data confirms that the product is safe and reduces the
number of S. aureus organisms following treatment," said
William (Bud) Foran, Chairman and Chief Executive Officer of
Micrologix. "Based on the level of reduction seen and our experience in
screening subjects for this trial, we believe that the future clinical
development program for MBI 853NL would involve greater risk, time and costs
than we can justify. We will now focus our resources on our later-stage
products that are more promising and carry greater near-term market potential.
We will also accelerate the development of additional pre-clinical compounds
based on our proprietary platform technology."
Anti-Inflammatory Properties of MBI Peptides Promising for Acne Program and
Other Dermatological Applications
Acne is the most common inflammatory skin disease of adolescence and early
adulthood. New preclinical data demonstrate that Micrologix’s peptides have
significant anti-inflammatory properties. In an in vivo animal model of
hypersensitivity (allergic reaction), MBI’s peptides showed a marked
reduction in the inflammatory response, similar to that of hydrocortisone,
which is acknowledged to be a potent anti-inflammatory agent. This important
property strengthens the data to support that MBI 594AN, currently in a Phase
II clinical trial, will be effective in treating acne. Previously, the Company
has reported preclinical and clinical data on the antibacterial properties of
MBI 594AN, including activity against antibiotic-resistant strains of
Propionibacterium acnes – the most important bacterium associated with acne.
In addition to acne, this data suggests that MBI’s peptides hold promise for
treating other dermatological conditions.
About Micrologix
Micrologix develops novel drugs targeted at severe and life-threatening
diseases — particularly those caused by antibiotic-resistant bacteria. The
Company’s portfolio of antibiotic drug candidates is based on improved
analogs of naturally occurring cationic peptides found in the host defense
systems of most life forms. Micrologix currently has two drugs in clinical
trials in the United States: MBI 226 for preventing catheter-related
bloodstream infections in Phase III clinical trials and MBI 594AN for treating
acne in Phase II. The Company’s common shares are included in the TSE 300
Composite Index.
William J. (Bud) Foran
Chairman, President & CEO
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The foregoing news release
contains forward-looking statements within the meaning of the United States
Private Securities Litigation Reform Act of 1995. All statements other than
statements of historical fact may be deemed to be forward-looking statements.
Forward-looking statements frequently, but not always use the words
"expects", "anticipates", "suggests",
"plans", "believes" or "intends", or similar words
and/or include statements concerning the Company’s strategies, goals and
plans, or state that certain actions, events or results "will" be
taken, occur or be achieved. These forward-looking statements involve known and
unknown risks, uncertainties and other factors which may cause the actual
results, performance or achievement of the company, or industry results, to be
materially different from any future results, performance or achievements
expressed or implied by such statements. Such factors include, among others,
those described in the Company’s annual report on Form 20-F, including
the following: uncertainties related to early stage of development, technology
and product development; dependence on future corporate collaborations;
dependence on proprietary technology and uncertainty of patent protection;
management of growth; future capital needs and uncertainty of additional
funding; intense competition; manufacturing and market uncertainties; government
regulation; product liability exposure and insurability.
The Toronto Stock Exchange and the Canadian Venture Exchange have not
reviewed and do not accept responsibility for the adequacy or accuracy of this
release.
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