RIV-CARE

The RIV-CARE Trial (NCT07431307) is an international, multicentre Phase IIb clinical trial evaluating BV100 plus low dose polymyxin B as a therapy for severe infections caused by carbapenem-resistant Acinetobacter baumannii-calcoaceticus complex (CRABC).

CRABC is a major cause of healthcare-associated infections and is recognised as one of the most challenging multidrug-resistant pathogens to treat, with mortality rates reaching 50% globally.  CRABC infections, including ventilator-associated bacterial pneumonia (VABP), hospital-acquired bacterial pneumonia (HABP) and bloodstream infections (BSIs), are serious life-threatening conditions associated with rapid clinical deterioration, high mortality, and substantial morbidity.  

There remains a clear unmet medical need globally, where CRABC continues to be highly prevalent in critically ill hospitalised patients. Currently available regimens are limited by toxicity, inconsistent efficacy, and the increasing occurrence of resistance to available treatments.

BV100 is developed for this high unmet medical need and to overcome these limitations.

BV100 is a novel intravenous formulation of the antibiotic rifabutin developed to target severe CRABC infections. Its novel mode of action allows the drug to specifically enter into CRABC and kill these pathogens effectively.  The addition of a low dose of polymyxin B to BV100 aims to potentiate the activity of BV100 while decreasing the likelihood of treatment-emergent resistance development.

Mode of action innovation: BV100 uses the siderophore receptor FhuE in CRABC to actively penetrate into the bacterium, achieving very high intracellular levels and potent killing, including multidrug resistant strains to which available therapies are ineffective. 

Novel formulation BV100: Rifabutin is only slightly soluble in aqueous solutions and is currently only available as an oral drug. BioVersys has developed a novel intravenous formulation, which enables us to deliver BV100 as an infusion. This allows BV100 to reach higher and predictable drug levels in the body, which are required to clear serious infections by CRABC.

In vitro, the combination of BV100 with polymyxin B and cefiderocol showed synergy and a reduction in the emergence of resistance, suggesting improved treatment outcomes in patients.

The RIV-CARE trial follows the successful completion of a Phase II study that showed that BV100 plus polymyxin B halved all-cause mortality compared with best available therapy, meaning 28-day mortality of 25% compared to 28-day mortality of 60% in best available therapy.

Study Design & Objectives

Primary Objective

• To evaluate the safety of BV100 in combination with low-dose polymyxin B plus ceftazidime-avibactam or cefiderocol.

Secondary Objectives

• To compare the efficacy of BV100-based combination therapy with best available therapy.
• To evaluate the pharmacokinetic profile of BV100 in blood plasma and cerebrospinal fluid.
• To evaluate clinical and microbiological outcomes following treatment.

Trial Organisation

The RIV-CARE Trial is partially funded by the Wellcome Trust. The study is coordinated by the Advancing Clinical Evidence in Infectious Diseases (ADVANCE-ID) network that is part of the National University of Singapore (NUS). BioVersys, the developer of BV100, is acting as sponsor of the clinical trial.

Communication Notice

Investigational product notice.
BV100 is an investigational medicinal product. It has not been approved or authorised by any regulatory authority, including Swissmedic, the European Medicines Agency, the U.S. Food and Drug Administration, or the Health Sciences Authority of Singapore, and its safety and efficacy have not been established. The RIV‑CARE trial (NCT07431307) is ongoing to evaluate BV100 in combination with low‑dose polymyxin B plus ceftazidime‑avibactam or cefiderocol.

Information only — not medical advice.
This page is provided for scientific and informational purposes only. It is not intended to constitute medical advice, diagnosis, or treatment recommendations, and should not be relied upon as such. Patients should always consult a qualified healthcare professional regarding any medical condition or treatment.

Not a recruitment communication.
This content is not intended to recruit patients into the RIV‑CARE trial. Trial participation occurs only at authorised investigational sites in accordance with the approved protocol and applicable laws; eligibility cannot be assessed through this website.

Forward‑looking statements.
Certain statements in this content relate to future events or expectations regarding BV100 and the RIV‑CARE trial. Such statements are based on current assumptions and are subject to known and unknown risks and uncertainties; actual results may differ materially. Readers should not place undue reliance on these statements.