Arena believes that the issues raised by the FDA may be resolvable using available data, but the company does not rule out the possibility that additional data may need to be generated before the FDA will approve the trial.
If no additional data are required, Arena believes it will be able to initiate the trial around mid-year. If additional data are required, Arena expects the initiation of the trial will be delayed until the fourth quarter of this year. In either event, the company believes that the delay will not affect the company’s longer-term timeline of submitting an NDA in 2009.
“Even if we are ultimately required to submit data that is not currently available, any required studies should be relatively short in duration and should be completed in time for us to initiate the phase II trial later this year,” stated Dr William Shanahan, Arena’s vice president and chief medical officer.
In related news, Arena recently received results from its chronic twelve and six-month pre-clinical toxicology studies of APD356, its orally administered, internally discovered drug candidate for the treatment of obesity.
The toxicology studies did not demonstrate any apparent drug effect on heart valves or pulmonary vasculature, and Arena continues to expect to initiate the APD356 phase III program in the second half of 2006.