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
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.
SOURCE Oxagen Limited