glucopyranosyl lipid A (REVTx-99) / Revelation BioSci - LARVOL DELTA

PRIME: Evaluation of the Safety and Tolerability of Gemini in Subjects With Stage 3-4 Chronic Kidney Disease. (clinicaltrials.gov) - P1/2 | N=40 | Completed | Sponsor: Revelation Biosciences, Inc | Recruiting ➔ Completed

Trial completion • Chronic Kidney Disease • Nephrology • Renal Disease

Gemini Priming Attenuates Inflammation in Human Peripheral Blood Mononuclear Cells (Businesswire) - "Priming with Gemini significantly decreased proinflammatory cytokines and significantly increased anti-inflammatory cytokines, relative to placebo....Two relevant measures following HMGB-1 and LPS challenge. This fundamental change in responsiveness at the cellular level demonstrates how Gemini will protect against inflammation-mediated damage. Revelation intends to share the full results from this study in a future publication....As a part of the PRIME (PReconditioning IMmunostimulatory Evaluation) Phase 1b clinical study in patients with Stage 3 and 4 Chronic Kidney Disease (CKD), Revelation is collecting PBMCs from dosed patients and anticipates demonstration of the attenuated response to HMGB-1 and LPS ex vivo relative to placebo subjects. Top-line data comprising safety, tolerability, and this demonstration of protection from relevant promotors of inflammation at a cellular level are expected by mid 2025."

P1/2 data • Preclinical • Chronic Kidney Disease

PRIME: Evaluation of the Safety and Tolerability of Gemini in Subjects With Stage 3-4 Chronic Kidney Disease. (clinicaltrials.gov) - P1/2 | N=40 | Recruiting | Sponsor: Revelation Biosciences, Inc

New P1/2 trial • Chronic Kidney Disease • Nephrology • Renal Disease • CRP • IL1B • IL6 • TNFA

Effect of REVTx-99 on alleviating or preventing allergy symptoms (ANZCTR) - P1 | N=28 | Completed | Sponsor: Linear Clinical Research Ltd | Not yet recruiting ➔ Completed

Trial completion • Allergic Rhinitis • Allergy • Immunology • Inflammation

Revelation Biosciences Doses First Patient in PRIME Phase 1b Clinical Study of Gemini in CKD Patients (Businesswire) - "Revelation Biosciences, Inc...announced dosing of the first patient in the PRIME (PReconditioning IMmunostimulatory Evaluation) Phase 1b clinical study of intravenous single ascending doses of Gemini in patients with Stage 3 and 4 Chronic Kidney Disease (CKD). The US-based, multi-site, placebo-controlled study will enroll up to forty patients in up to five cohorts...Top-line data comprising safety, tolerability, and key biomarkers of activity including attenuation of the inflammatory response are expected by mid-year."

P1 data • Trial status • Chronic Kidney Disease

Effect of REVTx-99 on alleviating or preventing allergy symptoms (ANZCTR) - P1; N=28; Not yet recruiting; Sponsor: Linear Clinical Research Ltd

Clinical • New P1 trial • Allergic Rhinitis • Allergy • Immunology

[VIRTUAL] Revelation Biosciences (BIO 2021) - "REVTx‑200 is based on the same technology used in REVTx‑99. In addition to the Company’s therapeutic pipeline, Revelation is also developing REVDx‑501, a rapid point of care diagnostic that can be used to detect any respiratory viral infection, regardless of virus type or strain, without the need for specialized instrumentation."

Immune Modulation • Immunology • Infectious Disease • Inflammation • Novel Coronavirus Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

Revelation Biosciences Inc. Completes Dosing of Five Single Dose Cohorts and Receives Approval to Initiate a Multiple Dose Cohort to Phase 1 Clinical Study of REVTx-99, an Experimental Treatment for Respiratory Viral Infection, Including COVID-19 (Businesswire) - "...it has been granted approval by the Bellberry Human Research Ethics Committee (HREC) in Australia to add a multiple dose cohort to its Phase 1 clinical study of REVTx-99 in healthy volunteers...The Phase 1 study single dose escalation portion of the study was completed in January 2021, in which 40 study participants were dosed...Revelation expects the multiple dose cohort enrollment of RVL-NHV01 to be completed in February 2021, followed by the announcement of topline data by the end of the first quarter of 2021. Revelation plans to initiate a Phase 1/2 study during the first half of 2021 in early stage COVID-19 patients at risk for hospitalization."

Enrollment status • New P1/2 trial • P1 data • Trial status • Infectious Disease • Novel Coronavirus Disease

Revelation Biosciences Inc. Announces the Start of a Phase 1 Clinical Study for REVTx‑99, an Experimental Treatment for Respiratory Viral Infection, Including COVID‑19 (Businesswire) - "Revelation Biosciences Inc....announced today that the first cohort of its Phase 1 clinical study of REVTx‑99 in healthy volunteers (RVL‑NHV01 study) has completed dosing. Eight study participants were dosed with REVTx-99 (n=6) or placebo (n=2) in Australia starting November 12, 2020....Revelation expects to announce the topline data early in the first quarter of 2021....After completion of this study, Revelation plans to initiate a Phase 2 study during the first half of 2021 in early stage COVID‑19 patients at risk for hospitalization."

New P2 trial • P1 data • Trial status • Infectious Disease • Novel Coronavirus Disease

Revelation Biosciences Inc. Receives Approval to Start a Phase 1 Clinical Study of REVTx-99 an Experimental Treatment for COVID-19 (Streetinsider.com) - "Revelation Biosciences Inc....announced today that it has been granted approval by the Bellberry Human Research Ethics Committee (HREC) in Australia to conduct a Phase 1 clinical study of REVTx-99 in healthy volunteers....RVL-HV01 is a single site, placebo-controlled, single dose, escalating dose study....RVL-HV01 will enroll up to 32 participants....Revelation expects enrollment of RVL-HV01 to begin during the fourth quarter of 2020, with topline data early in the first quarter of 2021. After completion of this study, Revelation plans to initiate a Phase 2 study during the first half of 2021 in early stage COVID-19 patients..."

New P1 trial • New P2 trial • P1 data • Infectious Disease • Novel Coronavirus Disease