Oxagen Completes Recruitment for Phase IIb Clinical Trial in Asthma

Strategic Insights -

Oxagen Limited, a drug discovery and development company, has announced the completion of recruitment for its double-blind, randomized, placebo-controlled Phase IIb clinical trial in asthma with OC000459, its lead oral CRTH2 (DP2) antagonist. The study, initiated in mid-May 2009, involves 440 asthmatic patients with moderate persistent asthma who will be randomized to one of three possible dose levels of OC000459 or placebo for a 12-week dosing period. The primary end point is lung function improvement, as measured by clinic FEV1. The trial aims 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.

Key Takeaways:

  • The Phase IIb trial involves 440 asthmatic patients with moderate persistent asthma, making it one of the largest clinical trials in the field of asthma research.
  • The study aims to evaluate the efficacy and safety of OC000459, a potent, selective, and orally active CRTH2 antagonist, in improving lung function and reducing asthma symptoms.
  • The primary end point of the trial is lung function improvement, as measured by clinic FEV1, which is a well-established indicator of asthma severity.
  • The trial follows the successful completion of a Phase IIa programme, which demonstrated efficacy of OC000459 in asthma and allergic rhinoconjunctivitis, and involved the treatment of over 600 subjects.
  • Oxagen's CRTH2 antagonist programme has received significant investment, including a £16 million Series C financing led by Novartis Venture Funds.
  • The company's pipeline of novel small molecule drugs is based on targets validated in man, and Oxagen is established as a leading player in the field of inflammatory and respiratory diseases.

Statistics:

  • 440 asthmatic patients with moderate persistent asthma will be involved in the Phase IIb trial.
  • The trial aims to evaluate the efficacy and safety of OC000459 in improving lung function and reducing asthma symptoms in patients with moderate persistent asthma.
  • Over 600 subjects have been treated with OC000459 to date, indicating a significant progress in the development of this compound.
  • The trial is expected to complete by the end of Q2 2010.
  • Oxagen has received £16 million ($26.7 million) in funding from Novartis Venture Funds for its CRTH2 antagonist programme.

Sources:

  • Oxagen Limited: Press Release: Oxagen Completes Recruitment for Phase IIb Clinical Trial in Asthma.
  • About Oxagen: Oxagen Limited: About Us.
  • About CRTH2 and OC000459: Oxagen Limited: CRTH2 and OC000459.