From the 10K- Filed on March 14th, so known before the Barclay's presentation on March 12th. Not sure if this was mentioned. Both extended from 48 to 96 weeks. So now Q2 19 will still report on Apex-2 at 24 weeks- with final results now at 96 weeks instead of 48? Another year in delayed final results and NDA filing? Or am I missing something?
Doubling the dosing period for 2 trials is something that should have been mentioned with reasoning behind it, yes?
Thanks map, appreciate your follow up comments on the win-win opinion.
APeX-2 Trial: APeX-2 is a Phase 3 double-blinded, placebo-controlled, three-arm clinical trial evaluating two dose levels of BCX7353 administered orally once-daily as a preventive treatment to reduce the frequency of attacks in patients with HAE. APeX-2 is testing once-daily BCX7353 at 110 mg and 150 mg for prevention of angioedema attacks. The trial enrolled patients with Type I and II HAE in the United States, Canada and Europe. The primary efficacy endpoint of APeX-2 is the rate of angioedema attacks over 24 weeks of study drug administration. On November 6, 2018, we announced we had completed enrollment in APeX-2 and had enrolled approximately 120 patients.
APeX-S Trial: APeX-S is a long-term safety trial evaluating two dose levels of BCX7353 administered orally once-daily as a preventive treatment in patients with HAE.APeX-S is an open label two-arm trial to evaluate the safety of once-daily BCX7353 at 110 mg and 150 mg over 48 weeks in patients with Type I and II HAE. The trial will enroll at least 160 patients. On November 6, 2018, we announced we have met the 100 subjects needed at each dose level (cumulative, summing APeX-2 and APeX-S) for regulatory requirements and expect to file a NDA in the fourth quarter of 2019.
The APeX-2 and APeX-S trials have both recently been amended to extend the duration of dosing through 96 weeks