What is the anticipated timeline for patient enrollment and data read‑out from the EMBRACE trial in Ireland, Poland, and Greece?
Answer
The press release you referenced does not include specific dates or milestones for the patient‑enrollment period or the data‑read‑out timeline for the EMBRACE™ study in Ireland, Poland, and Greece. It only announces that the Irish Medicines Board has granted the Clinical Trial Application (CTA) approval, allowing the trial to be initiated in those three countries.
What this means for the timeline
| Item | Information from the release | Typical industry expectations (for context only) |
|---|---|---|
| Start of enrollment | Not dated – the release simply states that the CTA approval “allows the study to be initiated.” | Once a CTA is granted, sites usually open to enrollment within a few weeks to a couple of months, depending on site readiness and regulatory logistics. |
| Projected enrollment period | No timeline provided. | Multinational Phase 3 studies of this size often target 12–18 months to recruit the full patient cohort, but the exact period can vary widely based on the number of sites, inclusion criteria, and patient‑availability. |
| Data read‑out (primary endpoint analysis) | No date or timeframe mentioned. | After the last patient is enrolled, a follow‑up period (e.g., 6–12 months) is typical before a primary‑endpoint analysis, followed by a data‑read‑out that may occur 12–24 months after the first patient is dosed, depending on the study design. |
Bottom line:
Based solely on the information in the news release, there is no publicly disclosed timeline for either patient enrollment or the subsequent data read‑out for the EMBRACE™ trial in Ireland, Poland, and Greece. If you need precise milestones, you would have to wait for a follow‑up announcement from Cybin (or a detailed clinical‑trial registry entry) that outlines the enrollment start date, target enrollment duration, and expected timing of the primary‑endpoint data read‑out.