AOP Orphan Pharmaceuticals and Lantibio Announce Positive Phase II Study with Novel Cystic Fibrosis Therapy



    VIENNA, Austria and CHAPEL HILL, N.C., US, March 6 /CNW/ -- AOP Orphan
Pharmaceuticals AG ("AOP Orphan") and Lantibio, Inc. ("Lantibio") today
announced positive final results from their placebo controlled, double-blinded
Phase II clinical study of Moli1901, an experimental compound to treat cystic
fibrosis ("CF").  Moli1901 is being developed by AOP Orphan in Europe under a
licensing and commercialization agreement with Lantibio.  The study, performed
at multiple centers in Europe, was designed to investigate safety and
tolerability of aerosolized Moli1901 in adolescents (12 years of age or older)
and adults with CF.
    The study was first populated with 9 subjects aged 16 years and older
(Phase I), followed with 9 subjects aged 12-16 years (Phase II).  Safety and
tolerability were assessed by spirometric evaluation of pulmonary function,
vital signs, pulse oximetry, physical examinations, clinical laboratory tests,
electrocardiogram (ECG), and by monitoring adverse events. Efficacy was
assessed by pre-treatment and post-treatment pulmonary function evaluation
measuring forced expiratory volume in one second (FEV1), forced vital capacity
(FVC), and forced expiratory flow 25-75% of FVC. Exercise tolerance and
quality of life were also assessed.
    Results of the study demonstrated that subjects ages 12 and older
tolerated daily administration of Moli1901 over 28 days of daily dosing by the
inhalation route and analysis of the data did not reveal unexpected safety
concerns.  Furthermore, no traces of Moli1901 were detected in the plasma of
subjects indicating that the drug has limited or no systemic absorption.
Notably, although the study was not powered to demonstrate efficacy, patients
who received 2.5 mg Moli1901 per day demonstrated a statistically significant
improvement of lung function as demonstrated by FEV1, a standard measure of
lung capacity in CF patients. The median FEV1 change from day 1 to the final
evaluation on day 56 amounted to -3% in the placebo group and 2% in the
Moli1901 group (Wilcoxon test, p=0.0217).  Further statistically significant
improvements of the patients receiving Moli1901 were observed in the patients'
subjective health perception as measured by the CF-validated Quality of Life
Questionnaire.
    "These early indications of efficacy of a Moli1901-based therapy are
extremely encouraging to both cystic fibrosis patients and AOP Orphan," said
Dr. Rudolf Widmann, CEO of AOP Orphan Pharmaceuticals AG. "We are pleased with
the fast progress of our development program that has already entered the next
stage with trials designed for confirmatory proof of efficacy and safety."
    "We are pleased with the outcome of this study.  We are looking forward
to the results of the next studies of AOP Orphan and regulatory steps toward
registration in key territories, including the United States," said Dr. Luis
Molina, CEO of Lantibio, Inc.

    
    About Moli1901
    
    In CF, absence or dysfunction of the chloride channel CFTR causes reduced
chloride ion and water transport in respiratory epithelial cells. This results
in an altered water content in the airway surface liquid (ASL), leading to
thick mucus secretion, inflammation and infection in the CF lung.  Moli1901 is
a stable 19-residue polycyclic peptide produced by fermentation of
Streptomyces cinnamoneum.  In previous published studies, Moli1901 has been
shown to increase chloride transport and fluid secretions when applied to
airway epithelium in-vitro, and increases chloride permeability in nasal
epithelium of healthy individuals and subjects with CF. In addition, animal
experiments have shown that Moli1901 increased the volume of ASL, was slowly
eliminated from the lung, and did not accumulate substantially in other
tissues. Results of a previous clinical study performed by AOP Orphan in
Europe presented in oral and poster format at the 20th Annual North American
Cystic Fibrosis Conference, Denver, Colorado, November 2-5, 2006, indicated
that dosing of Moli1901 for 5 consecutive days by the inhalation route
improved lung function in a dose-dependent manner.

    
    About AOP Orphan
    
    AOP Orphan Pharmaceuticals AG is a privately held corporation founded in
Vienna in 1997. The company is dedicated to developing, marketing and
distributing medicines in niche indications on a Pan-European level with
special focus on Central and Eastern Europe, Middle East and Southern Asia.

    
    About Lantibio
    
    Lantibio, Inc. is a development pharmaceutical company focused on
discovery, development, and marketing of products for the treatment of ocular
disease and serious respiratory conditions. Lantibio's lead product, Moli1901
holds an IND in CF in the US as well as Orphan Drug status in that indication.

    This press release might contain forward-looking statements as defined in
the Private Securities Litigation Reform Act of 1995. These statements are
based on current expectations of future events. If underlying assumptions
prove inaccurate or unknown risks or uncertainties materialize, actual results
could vary materially from AOP Orphan's and/or Lantibio's expectations and
projections. Risks and uncertainties include success of clinical trials for
AOP Orphan's and/or Lantibio's products, intellectual property risks, need for
additional financing or capital, ability to develop and successfully
commercialize our products, ability to enter into licensing agreements, and
the ability of the competition to render AOP Orphan's and/or Lantibio's
product candidates or technologies obsolete or noncompetitive. AOP Orphan and
Lantibio assume no obligation to update any forward-looking statements as a
result of new information or future events or developments, except as required
by law.





For further information:

For further information: Luis Molina, President-CEO of Lantibio, 
+1-919-960-0217, or lmolina@lantibio.com; Rudolf S. Widmann, CEO of AOP 
Orphan Pharmaceuticals, +43 1 503 72 44, or rudolf.widmann@aoporphan.com; 
Copy Editing & Distribution: PR&D - Public Relations for Research &
Development,  +43 1 505 70 44, or contact@prd.at Web Site:
http://www.lantibio.com

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LANTIBIO, INC.

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