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."
Organizations
Other news from the department research and development

Get the life science industry in your inbox
By submitting this form you agree that LUMITOS AG will send you the newsletter(s) selected above by email. Your data will not be passed on to third parties. Your data will be stored and processed in accordance with our data protection regulations. LUMITOS may contact you by email for the purpose of advertising or market and opinion surveys. You can revoke your consent at any time without giving reasons to LUMITOS AG, Ernst-Augustin-Str. 2, 12489 Berlin, Germany or by e-mail at revoke@lumitos.com with effect for the future. In addition, each email contains a link to unsubscribe from the corresponding newsletter.