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

m 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 Fibros
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