Revelation Biosciences Starts its PRIME Phase 1b Clinical Study of Gemini in CKD Patients
Revelation Biosciences (NASDAQ: REVB) has initiated its PRIME (PReconditioning IMmunostimulatory Evaluation) Phase 1b clinical study for Gemini in patients with Stage 3 and 4 Chronic Kidney Disease (CKD). The study will evaluate escalating doses of intravenously administered Gemini across five cohorts, enrolling up to forty patients in a US-based multi-site placebo-controlled trial.
Dosing is scheduled to begin in mid-February, with topline data expected by mid-year. The results will include safety, tolerability, and biomarkers of target activity. The data from this PRIME clinical study will support future development in both the GEM-CKD and GEM-AKI programs.
Revelation Biosciences (NASDAQ: REVB) ha avviato il suo studio clinico di fase 1b PRIME (PReconditioning IMmunostimulatory Evaluation) per Gemini in pazienti con malattia renale cronica (CKD) di fase 3 e 4. Lo studio valuterà dosi crescenti di Gemini somministrato per via endovenosa su cinque coorti, arruolando fino a quaranta pazienti in uno studio controllato con placebo multicentrico negli Stati Uniti.
Le somministrazioni sono programmate per iniziare a metà febbraio, con i dati preliminari attesi entro metà anno. I risultati includeranno la sicurezza, la tollerabilità e i biomarcatori di attività target. I dati di questo studio clinico PRIME supporteranno lo sviluppo futuro sia nei programmi GEM-CKD che GEM-AKI.
Revelation Biosciences (NASDAQ: REVB) ha iniciado su estudio clínico de fase 1b PRIME (PReconditioning IMmunostimulatory Evaluation) para Gemini en pacientes con enfermedad renal crónica (CKD) en etapa 3 y 4. El estudio evaluará dosis crecientes de Gemini administrado por vía intravenosa en cinco cohortes, reclutando hasta cuarenta pacientes en un ensayo controlado con placebo multicéntrico en EE. UU.
Las dosis están programadas para comenzar a mediados de febrero, con datos preliminares esperados para mediados de año. Los resultados incluirán seguridad, tolerabilidad y biomarcadores de actividad objetivo. Los datos de este estudio clínico PRIME apoyarán el desarrollo futuro en los programas GEM-CKD y GEM-AKI.
레벨레이션 바이오사이언스(REVB, NASDAQ)는 3단계 및 4단계 만성 신장 질환(CKD) 환자들을 대상으로 Gemini의 PRIME(PReconditioning IMmunostimulatory Evaluation) 1b 임상 연구를 시작했습니다. 이 연구에서는 정맥 주사로 투여되는 Gemini의 용량을 단계적으로 평가하며, 5개의 집단에 걸쳐 최대 40명의 환자를 등록할 예정입니다. 이 연구는 미국 내 다기관 위약 대조 연구입니다.
투약은 2월 중순에 시작할 예정이며, 중간 데이터는 연중반에 예상됩니다. 결과에는 안전성, 내약성 및 목표 활성의 바이오마커가 포함될 것입니다. 이 PRIME 임상 연구의 데이터는 GEM-CKD 및 GEM-AKI 프로그램의 향후 개발을 지원할 것입니다.
Revelation Biosciences (NASDAQ: REVB) a lancé son étude clinique de phase 1b PRIME (PReconditioning IMmunostimulatory Evaluation) pour Gemini chez des patients atteints de maladie rénale chronique (CKD) de stade 3 et 4. L'étude évaluera des doses croissantes de Gemini administrées par voie intraveineuse à travers cinq cohortes, en recrutant jusqu'à quarante patients dans un essai contrôlé par placebo multisitulaire basé aux États-Unis.
L'administration devrait débuter à la mi-février, avec des données préliminaires attendues d'ici le milieu de l'année. Les résultats comprendront la sécurité, la tolérabilité et les biomarqueurs de l'activité cible. Les données de cette étude clinique PRIME soutiendront le développement futur des programmes GEM-CKD et GEM-AKI.
Revelation Biosciences (NASDAQ: REVB) hat seine PRIME (PReconditioning IMmunostimulatory Evaluation) Phase 1b-Studie für Gemini bei Patienten mit chronischer Nierenerkrankung (CKD) im Stadium 3 und 4 gestartet. Die Studie wird steigende Dosen von intravenös verabreichtem Gemini in fünf Kohorten bewerten und bis zu vierzig Patienten in einer US-basierten multizentrischen placebokontrollierten Studie einschließen.
Die Dosierung soll Mitte Februar beginnen, wobei die vorläufigen Daten bis zur Jahresmitte erwartet werden. Die Ergebnisse umfassen Sicherheit, Verträglichkeit und Biomarker der Zielaktivität. Die Daten aus dieser PRIME-Studie unterstützen die zukünftige Entwicklung sowohl in den GEM-CKD- als auch in den GEM-AKI-Programmen.
- Advancement to Phase 1b clinical trial stage
- Multi-site study design strengthens data validity
- Results expected within 6 months showing quick timeline to data
- Early-stage clinical trial with no guarantee of success
- patient enrollment size of only 40 participants
Insights
The initiation of the PRIME Phase 1b study for Gemini represents a critical developmental milestone for Revelation Biosciences' CKD program. The study design is particularly noteworthy - utilizing five cohorts with escalating doses and incorporating up to 40 patients with Stage 3 and 4 CKD will provide robust preliminary safety and biomarker data.
The multi-site, placebo-controlled nature of the trial strengthens its scientific validity. The focus on both Stage 3 and 4 CKD patients is strategically important, as these represent progressive disease states where therapeutic intervention could be most impactful. The planned biomarker analysis will be important for understanding Gemini's mechanism of action and potential efficacy signals.
The mid-year timeline for topline data suggests a relatively rapid execution, which could accelerate the development pathway if positive results are obtained. The dual application potential for both CKD and Acute Kidney Injury (AKI) programs demonstrates efficient pipeline development strategy, as positive safety and biomarker data could support multiple therapeutic directions.
From a market perspective, this clinical trial initiation is strategically significant. The global CKD treatment market represents a substantial opportunity, with the chronic kidney disease therapeutics market projected to reach $16.7 billion by 2025. Specifically targeting Stage 3 and 4 CKD patients positions Gemini in a critical intervention window where effective treatments are desperately needed.
The potential dual application for both CKD and AKI creates multiple commercialization pathways, effectively expanding the total addressable market. With REVB's current market cap of
– Dosing to Commence Mid-February –
– Topline data expected Mid-Year –
“I am delighted to see the Revelation teams’ hard work culminating with the start of the PRIME study.” said James Rolke, Chief Executive Officer of Revelation. “We look forward to the results and plan to educate the public over the next few months on the importance of the planned biomarkers as it relates to CKD treatment and prevention of AKI.”
Top-line data including safety, tolerability, and biomarkers of target activity are expected by mid-year. Data from the PRIME clinical study will support future development in both the GEM-CKD and GEM-AKI programs.
About AKI
AKI, also known as acute renal failure, is defined as a rapid loss of kidney function. AKI causes a build-up of waste products in blood and makes it more difficult for kidneys to maintain the correct balance of fluid in the body. AKI can also have a significant impact on other organs such as the brain, heart, and lungs.
About CKD
Chronic kidney disease is a pervasive problem in
About Gemini
Gemini is an intravenously administrated, proprietary formulation of phosphorylated hexaacyl disaccharide (PHAD®) that reduces the damage associated with inflammation by reprograming the innate immune system to respond to stress (trauma, infection, etc.) in an attenuated manner. Revelation has conducted multiple preclinical studies demonstrating the therapeutic potential of Gemini in the target indications. Earlier this year Revelation announced positive Phase 1 clinical data for intravenous treatment with Gemini. The primary safety endpoint was met in the Phase 1 study, and results demonstrated statistically significant pharmacodynamic activity as observed through expected changes in multiple biomarkers including upregulation of IL-10.
Gemini is being developed for multiple indications including as a pretreatment to prevent or reduce the severity and duration of acute kidney injury (GEMINI-AKI program), and as pretreatment to prevent or reduce the severity and duration of post-surgical infection (GEMINI-PSI program). In addition, Gemini may be a treatment to stop or slow the progression of chronic kidney disease (GEMINI-CKD program).
About Revelation Biosciences, Inc.
Revelation Biosciences, Inc. is a clinical stage life sciences company focused on harnessing the power of trained immunity for the prevention and treatment of disease using its proprietary formulation Gemini. Revelation has multiple ongoing programs to evaluate Gemini, including as a prevention for post-surgical infection, as a prevention for acute kidney injury, and for the treatment of chronic kidney disease.
For more information on Revelation, please visit www.RevBiosciences.com.
Forward-Looking Statements
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These forward-looking statements are generally identified by the words "anticipate", "believe", "expect", "estimate", "plan", "outlook", and "project" and other similar expressions. We caution investors that forward-looking statements are based on management’s expectations and are only predictions or statements of current expectations and involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from those anticipated by the forward-looking statements. Revelation cautions readers not to place undue reliance on any such forward looking statements, which speak only as of the date they were made. The following factors, among others, could cause actual results to differ materially from those described in these forward-looking statements: the ability of Revelation to meet its financial and strategic goals, due to, among other things, competition; the ability of Revelation to grow and manage growth profitability and retain its key employees; the possibility that the Revelation may be adversely affected by other economic, business, and/or competitive factors; risks relating to the successful development of Revelation’s product candidates; the ability to successfully complete planned clinical studies of its product candidates; the risk that we may not fully enroll our clinical studies or enrollment will take longer than expected; risks relating to the occurrence of adverse safety events and/or unexpected concerns that may arise from data or analysis from our clinical studies; changes in applicable laws or regulations; expected initiation of the clinical studies, the timing of clinical data; the outcome of the clinical data, including whether the results of such study is positive or whether it can be replicated; the outcome of data collected, including whether the results of such data and/or correlation can be replicated; the timing, costs, conduct and outcome of our other clinical studies; the anticipated treatment of future clinical data by the FDA, the EMA or other regulatory authorities, including whether such data will be sufficient for approval; the success of future development activities for its product candidates; potential indications for which product candidates may be developed; the ability of Revelation to maintain the listing of its securities on NASDAQ; the expected duration over which Revelation’s balances will fund its operations; and other risks and uncertainties described herein, as well as those risks and uncertainties discussed from time to time in other reports and other public filings with the SEC by Revelation.
View source version on businesswire.com: https://www.businesswire.com/news/home/20250121688279/en/
Mike Porter
Investor Relations
Porter LeVay & Rose Inc.
Email: mike@plrinvest.com
Chester Zygmont, III
Chief Financial Officer
Revelation Biosciences Inc.
Email: czygmont@revbiosciences.com
Source: Revelation Biosciences, Inc.
FAQ
When will Revelation Biosciences (REVB) release topline data for the PRIME Phase 1b study?
How many patients will be enrolled in REVB's PRIME Phase 1b study for Gemini?
What type of patients are eligible for REVB's Gemini PRIME study?
What programs will benefit from REVB's PRIME clinical study data?
When will dosing begin in REVB's PRIME Phase 1b study?
