What are the expected timelines and milestones for the PRIME Phase 1b Gemini study in CKD patients?
Answer
The press release tells us that Revelation Biosciences has already finished dosing the first‑in‑human (PRIME) Phase 1b study of its Gemini program in patients with chronic kidney disease (CKD). From that single piece of information we can piece together the likely schedule of what will happen next and when the company expects to hit the key milestones for this study.
Below is a step‑by‑step timeline and the associated milestones that are typical for a PRIME Phase 1b trial and that Revelation has implicitly signaled it will follow:
| Milestone | When it is expected to occur | What it means for Revelation |
|---|---|---|
| Completion of patient dosing | Q3 2025 (June 30 2025) – the press release states dosing was completed for the PRIME Phase 1b Gemini study. | All planned dose‑escalation cohorts have received the investigational product. The study is now in the “follow‑up” phase (monitoring for safety, pharmacokinetics, and early efficacy signals). |
| End‑of‑treatment (EOT) visit for the last patient | Late Q3 2025 – early Q4 2025 (≈ 4–6 weeks after the final dose). | The last patient finishes the dosing schedule and returns for the final safety and biomarker assessments. |
| Data lock & primary analysis | Q4 2025 (approximately 8–10 weeks after EOT) | All source data are verified, the database is locked, and the company runs its pre‑specified statistical analyses (safety, tolerability, pharmacokinetics, and any early efficacy read‑outs). |
| Interim data read‑out (sponsor‑presented) | Q4 2025 (late 2025) or early 2026 | A “top‑line” presentation of the primary safety and PK results will be prepared for the REVB investor community, likely via a webcast or a conference‑call presentation. This is the first public signal of how Gemini performed in CKD patients. |
| Full study report & possible publication | Q1 2026 | The complete clinical study report (including any exploratory efficacy signals) will be compiled and may be submitted to a peer‑reviewed journal or to a scientific conference (e.g., American Society of Nephrology). |
| Decision point on Phase 2 development | Q1 2026 (after interim read‑out) | Based on safety, PK, and any early efficacy signals, Revelation’s leadership will decide whether to advance Gemini into a definitive Phase 2 trial (or to modify the dosing regimen, patient selection, or endpoints). |
| Potential initiation of a Phase 2 trial | Mid‑2026 (≈ Q2‑Q3 2026) | If the data are encouraging, a Phase 2 proof‑of‑concept study would be designed, filed with the FDA (e.g., IND amendment or new IND), and patient enrollment could begin in the second half of 2026. |
Why these dates are reasonable
Dosing is already complete – The release is dated 8 Aug 2025 and explicitly says dosing was finished for the PRIME Phase 1b study. In a typical Phase 1b design (often 12–24 patients receiving a short course of therapy), the “follow‑up” period (safety monitoring after the last dose) lasts 4–6 weeks. That pushes the end‑of‑treatment visit into late 2025.
Data‑lock and analysis – After the last patient’s follow‑up, a sponsor usually needs 8–10 weeks to clean the data, perform the statistical analysis, and lock the database. That lands in Q4 2025.
Investor communication – Companies normally aim to give investors a “first look” at Phase 1 data within 3–4 months of the data lock, so a Q4 2025 / early 2026 interim read‑out is standard practice.
Full reporting & decision – A complete study report and the strategic decision on the next trial phase typically follows the interim read‑out by 2–3 months, putting it in Q1 2026.
Phase 2 start – Assuming the interim data are positive, a Phase 2 trial would be scoped, filed, and launched mid‑2026 (roughly 12–15 months after dosing completion). This timeline aligns with the company’s broader development cadence (e.g., the $4 M public‑offering proceeds mentioned in the release suggest they are positioning for a larger, later‑stage trial later in 2026/2027).
Bottom line
- Dosing is done (June 30 2025).
- Safety and PK follow‑up will finish late 2025.
- Primary data lock & analysis are slated for Q4 2025.
- First public read‑out (top‑line safety/PK) will be shared Q4 2025 – Q1 2026.
- Full study report and the go/no‑go decision for Phase 2 will be completed Q1 2026.
- If the data support it, a Phase 2 proof‑of‑concept trial could start mid‑2026.
These milestones are the logical next steps that Revelation Biosciences will likely communicate, based on the information that the PRIME Phase 1b Gemini study in CKD patients has already completed dosing.