Biotie reports positive top-line data from clinical study with its third generation oral PDE4 inhibitor
ELB353 is well tolerated and shows clear pharmacological activity
Biotie reported that it has successfully completed a Phase I trial with its orally administered phosphodiesterase 4 (PDE4) inhibitor ELB353, intended for the treatment of chronic obstructive pulmonary disease (COPD).
The study evaluated the safety, tolerability, pharmacokinetic characteristics and pharmacodynamic effects of repeated oral doses of ELB353 in 48 healthy male volunteers. ELB353 was generally well tolerated, and no serious or severe adverse events were reported in any of the study subjects. The pharmacokinetic characteristics of ELB353 demonstrated its suitability for a once daily dosing regimen. Robust and statistically highly significant biomarker responses confirmed the pharmacological activity of well tolerated doses of ELB353 in man.
"We are very pleased with the properties of ELB353 seen in this study", said Timo Veromaa, President and CEO of Biotie Therapies Corp. "These data, combined with the recommendation for approval of the first PDE4 inhibitor in the EU last week, confirm our commitment to move forward with a Phase II program in COPD patients and may also provide an interesting entry point for a partner into the development program."
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