Revelation Biosciences Inc. Announces FDA Acceptance of Gemini IND
Revelation Biosciences (NASDAQ: REVB) announced FDA acceptance of its investigational new drug (IND) application for Gemini. The company will initiate a US-based Phase 1b clinical study to evaluate Gemini as a preconditioning treatment in chronic kidney disease (CKD) patients. The study will enroll up to 40 subjects across 5 cohorts, focusing on safety and tolerability of a single Gemini dose. Positive results would enable a Phase 2 study targeting the reduction of acute kidney injury in patients undergoing coronary artery bypass graft and cardiac valve surgery.
Revelation Biosciences (NASDAQ: REVB) ha annunciato l'accettazione da parte della FDA della sua domanda di nuovo farmaco investigativo (IND) per Gemini. L'azienda avvierà uno studio clinico di Fase 1b negli Stati Uniti per valutare Gemini come trattamento precondizionante nei pazienti con malattia renale cronica (CKD). Lo studio recluterà fino a 40 soggetti distribuiti in 5 coorti, concentrandosi sulla sicurezza e tollerabilità di una singola dose di Gemini. Risultati positivi consentirebbero l'avvio di uno studio di Fase 2 mirato alla riduzione dell'infortunio renale acuto nei pazienti sottoposti a bypass coronarico e interventi di sostituzione valvolare cardiaca.
Revelation Biosciences (NASDAQ: REVB) anunció la aceptación por parte de la FDA de su solicitud de nuevo fármaco en investigación (IND) para Gemini. La compañía iniciará un estudio clínico de Fase 1b en EE.UU. para evaluar a Gemini como tratamiento de precondicionamiento en pacientes con enfermedad renal crónica (CKD). El estudio incluirá hasta 40 sujetos distribuidos en 5 cohortes, enfocándose en la seguridad y tolerabilidad de una sola dosis de Gemini. Resultados positivos permitirían el lanzamiento de un estudio de Fase 2 enfocado en la reducción de lesiones renales agudas en pacientes que se someten a cirugía de bypass de arteria coronaria y cirugía de válvula cardíaca.
레벨레이션 바이오사이언스 (NASDAQ: REVB)는 제미니에 대한 FDA의 신약 임상시험 승인(IND) 수락을 발표했습니다. 이 회사는 만성 신장 질환(CKD) 환자에서 제미니를 전처치 치료로 평가하기 위해 미국에서 1b상 임상 연구를 시작할 예정입니다. 이 연구는 5개의 집단에서 최대 40명을 포함하여 단일 제미니 투여량의 안전성과 내약성을 중점적으로 조사합니다. 긍정적인 결과는 관상 동맥 우회 수술 및 심장 판막 수술을 받는 환자에서 급성 신손상을 줄이는 것을 목표로 하는 2상 연구 진행을 가능하게 할 것입니다.
Revelation Biosciences (NASDAQ: REVB) a annoncé l'acceptation par la FDA de sa demande de nouveau médicament expérimental (IND) pour Gemini. L'entreprise va lancer une étude clinique de Phase 1b basée aux États-Unis pour évaluer Gemini en tant que traitement de préconditionnement chez les patients atteints de maladie rénale chronique (CKD). L'étude recrutera jusqu'à 40 sujets répartis en 5 cohortes, en se concentrant sur la sécurité et la tolérance d'une seule dose de Gemini. Des résultats positifs permettraient de mener une étude de Phase 2 visant à réduire les lésions rénales aiguës chez les patients subissant une chirurgie de pontage coronarien et une chirurgie de remplacement de valve cardiaque.
Revelation Biosciences (NASDAQ: REVB) hat die Akzeptanz des FDA-Antrags für ein neues investigational Medikament (IND) für Gemini bekannt gegeben. Das Unternehmen wird eine Phase 1b klinische Studie in den USA starten, um Gemini als Vorbehandlung bei Patienten mit chronischer Nierenerkrankung (CKD) zu evaluieren. Die Studie wird bis zu 40 Teilnehmer in 5 Kohorten einschließen, wobei der Fokus auf der Sicherheit und Verträglichkeit einer einzigen Dosis von Gemini liegt. Positive Ergebnisse würden eine Phase 2 Studie ermöglichen, die auf die Verringerung akuter Nierenverletzungen bei Patienten abzielt, die sich einer koronaren Bypass-Operation und Herzklappenoperation unterziehen.
- FDA acceptance of IND application for Gemini
- Advancement to Phase 1b clinical trials
- Clear pathway to Phase 2 studies pending positive results
- Study not expected to begin until early 2025
- initial study size of only 40 subjects
Insights
The FDA's acceptance of the IND for Gemini represents a significant regulatory milestone, enabling clinical trials in CKD patients. The Phase 1b study design with 40 subjects across 5 cohorts is relatively small but appropriate for initial safety assessment. The focus on preconditioning treatment for CKD patients undergoing cardiac surgery addresses a significant unmet medical need, as AKI is a common complication in this population.
The study's biomarker-driven approach to measure immune response modulation shows scientific rigor, though actual efficacy signals won't be clear until Phase 2. With a
-Phase 1b Study in CKD Patients to begin early 2025-
The multi-site, placebo-controlled Phase 1b clinical study will enroll up to 40 subjects in up to 5 cohorts. The primary endpoint is evaluation of the safety and tolerability of a single dose of Gemini in patients with CKD. Secondary and exploratory endpoints will assess the pharmacokinetics, and the potential of Gemini to mobilize and attenuate the innate immune response to stress by measuring several predictive biomarkers of efficacy.
Positive data from the Phase 1b study will enable a Phase 2 study of Gemini as a preconditioning treatment in patients with CKD to reduce the incidence, duration, and severity of acute kidney injury (AKI) in patients undergoing coronary artery bypass graft (CABG) and/or cardiac valve surgery.
“We are proud to receive acceptance of our IND for Gemini, marking our most important milestone to date for Revelation,” said James Rolke, Chief Executive Officer of Revelation. “By leveraging the unique properties of trained immunity, we are exploring new ways to improve patient outcomes. We will continue to move swiftly to initiate our Phase 1b clinical study in the near future.”
For more information on Revelation, please visit www.RevBiosciences.com.
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 (surgery, 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 has potential as 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 acute kidney injury, as a prevention for post-surgical infection, 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.
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Company Contacts
Chester Zygmont, III
Chief Financial Officer
Revelation Biosciences Inc.
Email: czygmont@revbiosciences.com
Source: Revelation Biosciences, Inc.
FAQ
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