stannous protoporphyrin (RBT-9) / Renibus Therap - LARVOL DELTA

SnPP: A Study of RBT-9 in Healthy Volunteers and Volunteers With Stage 3/4 Chronic Kidney Disease (clinicaltrials.gov) - P1 | N=42 | Completed | Sponsor: Renibus Therapeutics, Inc. | Phase classification: P1b ➔ P1

Phase classification • Chronic Kidney Disease • Nephrology • Renal Disease • IL10

A Study to Evaluate the Effect of RBT-9 on Progression of COVID-19 in High-Risk Individuals (The PREVENT Study) (clinicaltrials.gov) - P2 | N=42 | Terminated | Sponsor: Renibus Therapeutics, Inc. | N=252 ➔ 42 | Trial completion date: Jun 2022 ➔ Sep 2021 | Active, not recruiting ➔ Terminated | Trial primary completion date: Dec 2021 ➔ Sep 2021; Enrollment feasibility

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Infectious Disease • Novel Coronavirus Disease

A Study to Evaluate the Effect of RBT-9 on Progression of COVID-19 in High-Risk Individuals (The PREVENT Study) (clinicaltrials.gov) - P2; N=252; Active, not recruiting; Sponsor: Renibus Therapeutics, Inc.; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Infectious Disease • Novel Coronavirus Disease

A Study to Evaluate the Effect of RBT-9 on Progression of COVID-19 in High-Risk Individuals (The PREVENT Study) (clinicaltrials.gov) - P2; N=252; Recruiting; Sponsor: Renibus Therapeutics, Inc.; Trial completion date: Dec 2021 ➔ Jun 2022; Trial primary completion date: Jun 2021 ➔ Dec 2021

Clinical • Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease

[VIRTUAL] RBT-9 Antiviral Activity Against BK Virus (KIDNEY WEEK 2021) - "The 50% cytotoxic concentration (CC 50 ) in the in vitro studies averaged 89.2 µM, indicating RBT-9 did not adversely affect host cell viability at concentrations 16.5 times higher than its effective concentration. Conclusion Given the antiviral activity of RBT-9 against BK virus in vitro and the safety profile of RBT-9 in Phase 1 human studies, a clinical study assessing the efficacy of RBT-9 is warranted in patients who are at risk of developing BK virus-induced nephropathy."

Acute Kidney Injury • Infectious Disease • Nephrology • Transplantation

[VIRTUAL] Design of PREVENT: A Phase 2 Study of the Effect of RBT-9 on Progression of COVID-19 Infection in High-Risk Individuals, Including Those with Advanced CKD (KIDNEY WEEK 2020) - "The organ protective and antiviral effects of RBT-9 warrant conduct of this clinical study, which is aimed at preventing progression to severe COVID-19 and organ failure. The first patient is expected to be enrolled in June 2020. Funding: Commercial Support"

Clinical • P2 data • Acute Kidney Injury • Cardiovascular • Chronic Kidney Disease • Congestive Heart Failure • Dengue Fever • Diabetes • Diabetic Nephropathy • Genetic Disorders • Heart Failure • Infectious Disease • Metabolic Disorders • Nephrology • Novel Coronavirus Disease • Obesity • Renal Disease • Respiratory Diseases

[VIRTUAL] Biomarker and Safety Results from a Phase 1b Study of RBT-9 in Healthy Volunteers and Subjects with CKD Stage 3/4 (KIDNEY WEEK 2020) - "We conclude that RBT-9 was safe and well tolerated in healthy volunteers and subjects with CKD. Adverse events were generally mild and related to photosensitivity reactions. Dose-dependent cytoprotective protein responses were observed that have previously corresponded with AKI protection in experimental animals."

Biomarker • Clinical • P1 data • Acute Kidney Injury • Cardiovascular • Chronic Kidney Disease • Nephrology • Renal Disease • Reperfusion Injury • CST3 • HMOX1 • IL10 • KIM1 • NQO1

Renibus Therapeutics’ COVID-19 Treatment, RBT-9, Shows Antiviral Activity Against SARS-CoV-2 In Vitro (GlobeNewswire) - "Renibus Therapeutics, Inc., a clinical-stage biotechnology company, announced today that its investigational treatment for COVID-19, RBT-9, has demonstrated antiviral activity in vitro against SARS-CoV-2, the virus that causes COVID-19....'The inhibition of viral replication supports the potential of RBT-9 in treating patients with COVID-19'....Renibus is currently enrolling patients in a randomized, placebo-controlled Phase 2 clinical trial with RBT-9 in non-critically ill adults with COVID-19 who are at high risk of disease progression."

Enrollment status • Preclinical • Infectious Disease • Novel Coronavirus Disease

A Study to Evaluate the Effect of RBT-9 on Progression of COVID-19 in High-Risk Individuals (The PREVENT Study) (clinicaltrials.gov) - P2; N=252; Recruiting; Sponsor: Renibus Therapeutics, Inc.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Chronic Kidney Disease • Infectious Disease • Novel Coronavirus Disease

Renibus Therapeutics Receives FDA Fast Track Designation for RBT-9 Treatment in COVID-19 (GlobeNewswire) - "Renibus Therapeutics, Inc....announced today that it has been granted Fast Track designation by the FDA for RBT-9 treatment in COVID-19....RBT-9 has demonstrated antiviral activity in several enveloped viruses and inhibits a key mediator of viral replication in coronaviruses, including SARS-CoV-2 – the virus that causes COVID-19."

Fast track designation • Infectious Disease • Novel Coronavirus Disease

Frontier Scientific Develops and Provides Process to Produce Active Pharmaceutical Ingredient for Clinical Trial of COVID-19 Therapeutic Investigational Drug RBT-9 (Businesswire) - "Renibus Therapeutics Will Conduct Phase 2 Trial of Compound with Antiviral and Immune-Modulating Activity to treat effects of COVID-19; Frontier Scientific...today announced their collaboration with Renibus Therapuetics to develop a therapeutic for COVID-19....Frontier Scientific continues to provide technical consultation and problem-solving expertise to Renibus Therapeutics with regards to production of SnPP and support the continued development of RBT-9..."

Licensing / partnership • Trial initiation date • Infectious Disease • Novel Coronavirus Disease

Cascade Chemistry Selected to Produce Active Pharmaceutical Ingredient for Clinical Trial Supplies of COVID-19 Investigational Drug RBT-9 (Businesswire) - "Renibus Therapeutics Will Conduct Phase 2 Trial of Compound With Antiviral and Immune-Modulating Activity; Cascade Chemistry...today announced that it has been selected to produce the active pharmaceutical ingredient (API) for clinical trial supplies of RBT-9, an investigational therapy entering a Phase 2 trial for the treatment of COVID-19 patients....Renibus scientists moved quickly to plan and initiate a clinical trial of RBT-9 in COVID-19 patients."

Clinical • New P2 trial • Infectious Disease • Novel Coronavirus Disease

Datatrak International, Inc. Partners with Renibus Therapeutics, Inc. for Upcoming COVID-19 Clinical Trial (GlobeNewswire, Datatrak International) - "Datatrak International, Inc....announces a new partnership with Renibus Therapeutics, Inc. for their COVID-19 clinical trial....Renibus has been fast tracked by the FDA to begin a Phase 2 study to evaluate the effects of their drug, RBT-9 in COVID-19 patients who are at high-risk of deteriorating health due to age or comorbid conditions such as kidney or cardiovascular disease."

FDA event • Licensing / partnership • New P2 trial • Infectious Disease • Novel Coronavirus Disease

Effect of RBT-9 on Preventing Progression of COVID-19 in High-Risk Individuals (clinicaltrials.gov) - P2; N=252; Not yet recruiting; Sponsor: Renibus Therapuetics, Inc.

Clinical • New P2 trial • Infectious Disease • Novel Coronavirus Disease