Recruitment complete in Oxagen's OC000459 IIb clinical trial for asthma

Dec 9 2009

Oxagen Limited, a drug discovery and development company specializing in inflammation, today announced that the recruitment for its double blind, randomised, placebo controlled Phase IIb clinical trial in asthma with OC000459, its lead oral CRTH2 (DP2) antagonist, has now been completed.

The study, which was initiated in mid May 2009, is expected to complete by the end of Q2 2010. It involves 440 asthmatic patients with moderate persistent asthma who will be randomised to one of three possible dose levels of OC000459 or placebo by oral tablet for a 12 week dosing period, with lung function (improvement in clinic FEV₁) being the primary end point.

The purpose of the study is to determine the magnitude of further improvement in lung function and asthma symptoms on longer term therapy and to define the optimal once daily oral dose of OC000459.

Mark Payton PhD, Oxagen’s Chief Executive Officer said ”This represents an exciting time for Oxagen and a key phase in the clinical development of this compound following our recent successful proof-of–concept studies in both asthma and allergic rhinitis. We believe oral CRTH2 antagonists offer a valuable contribution to respiratory medicine and this study maintains Oxagen’s position as one of the leading players in this field.”

The Phase IIb trial follows the successful completion of a Phase IIa programme in which four Phase IIa trials were completed with efficacy demonstrated in asthma and allergic rhinoconjunctivitis. Over 600 subjects have been treated with OC000459 to date and results so far indicate the drug to be well tolerated.

Oxagen recently completed a £16 Million ($26.7 Million) Series C financing led by Novartis Venture Funds. The proceeds of the funding are being used primarily to advance the Company’s CRTH2 antagonist programme in inflammatory and respiratory diseases, including the completion of this Phase IIb clinical study of OC000459 in moderate persistent asthma.