The OLE was already completed in June according to the latest 10Q. Since Phase 2b/3 was not able to confirm the dose dependency, the OLE becomes the last opportunity (without a new trial) to confirm the dose dependency (aka 50mg halting the AD progression) shown in Phase 2a. Hopefully, there were enough patients enrolled and completed the OLE but the company's downplay of OLE and change of wording in 10Q make one wonder about the OLE efficacy and participation.
Only the p2b/3 completers can join the OLE, which was 313. Assuming an extremely high 90% OLE participation, a maximum of 280 patients enrolled in OLE. Recall only 20 patients completed PDD OLE. There is a chance the number of patients completing OLE can be as low as 44 if COVID-19 had the same impact.
A subsequent long-term open label extension study of ANAVEX®2-73, referred to as the ATTENTION-AD trial, was initiated for patients who completed the 48-week Phase 2b/3 placebo-controlled trial referenced above. This trial extension for a duration of up to 96 additional weeks was completed in June 2024. The trial will provide additional longer-term safety and efficacy data of ANAVEX®2-73 in persons with Alzheimer’s disease.
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