Sep 14 2009
Biotie starts clinical study with phosphodiesterase 4 inhibitor ELB353
Biotie has started a clinical trial with its phosphodiesterase 4 (PDE4) inhibitor ELB353, having received the prerequisite regulatory and ethical clearances for the clinical trial application.
The study will be conducted within the European Union and will evaluate the safety, tolerability, pharmacodynamics and pharmacokinetics of repeated doses of oral ELB353 in up to 48 healthy volunteers. The study is expected to provide proof of pharmacodynamic activity in humans, corroborate the safety profile and establish dose ranges for further therapeutic studies. Results are expected in the first half of 2010.
ELB353 is a once-daily, oral PDE4 inhibitor with therapeutic potential in chronic inflammatory disorders, particularly in chronic obstructive pulmonary disease (COPD), a serious disorder with major unmet medical need.
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