Wellcome awards CHF 14 million for BioVersys’ BV100 Phase 2b study

As a lead candidate in BioVersys’ portfolio, BV100 is a novel formulation of rifabutin suitable for intravenous administration, with a recently discovered novel mode of action showing an active uptake of rifabutin into the Gram-negative bacterial species, Acinetobacter baumannii. For the first time, BV100 allows for the targeting of the RNA-polymerase enzyme in Gram-negative bacteria with a human-suitable dose. 

BioVersys had announced its plan to conduct a Phase 2b study in parallel to the upcoming Phase 3 study in order to generate additional clinical data to support the future BV100 new drug application, collect additional clinical evidence in real world settings in countries with very high drug resistance levels and allow the comparison with some of the newest approved drugs. 

BV100 has been selected by an independent expert panel out of 24 applications to receive support for the Phase 2b. The study has obtained SGD 22 million (approximately c. USD 17m or CHF 14m) from the Wellcome who strengthened the ADVANCE-ID (ADVANcing Clinical Evidence in Infectious Diseases) network, enabling the first sponsor driven clinical trial run by ADVANCE-ID, has its hub at the Saw Swee Hock School of Public Health, National University of Singapore, in close collaboration with an industry sponsor, BioVersys. 

This Phase 2b will be conducted by the ADVANCE-ID clinical trial network in several countries in Southeast Asia, in settings with very high levels of drug-resistant infections and in close collaboration with BioVersys. In addition to significantly reducing the financial cost to BioVersys, conducting the Phase 2b in partnership with the ADVANCE-ID clinical trial network increases the number of treatment arms from two to three treatment arms, including two arms for BV100 combined with either Ceftazidime/avibactam or with Cefiderocol, and one arm for Best Available Therapy. 

Consequently, the total number of evaluable patients increases from 60 patients to 90 patients in Part A, compared to the initial Phase 2b development plan. This Phase 2b will enroll patients with VABP/HABP and BSI suffering from CRAB (Part A), and patients with CRAB ventriculitis and meningitis (Part B, additional 10 patients).

Professor David Paterson, Director of ADVANCE-ID said, “Carbapenem-resistant Acinetobacter baumannii (CRAB) has been classified as a “Critical” priority pathogen by WHO since 2017. BV100 is an attractive anti-infective which has already delivered very promising results in a Phase 2 VABP trial, and we are very happy with the choice made by our independent expert panel. We look forward to collaborating with BioVersys, with our clinical trial network providing the infrastructure, expertise and access to a large population of patients with life-threatening CRAB infections. These are exactly the patients who need the kind of innovative anti-infective potential that BV100 represents.”

This Phase 2b open label randomized trial is expected to dose the first patient in H1 2026 and to include an interim data read-out in H2 2026. The data generated are expected to contribute to the BV100 Phase 3 program aimed at regulatory submission in the US, Europe and China.

The mission of ADVANCE-ID is to conduct high-quality clinical trials that globally impact the management of infections. The network has already conducted clinical research in over 10,000 patients including over 3,000 in Ventilator Associated Bacterial Pneumonia (VABP) and Hospital Acquired Bacterial Pneumonia (HABP) and over 7,000 in Blood Stream Infections (BSI), finding that carbapenem-resistant Acinetobacter baumannii was the most common cause of these life-threatening infections across Asia. Wellcome originally supported the ADVANCED-ID set-up with funding in 2022 and has now provided a further 22 million SGD contribution to build clinical trial capacity and support this first Sponsor driven Phase 2 trial.

(Press release/RAN)
Picture: Jlievano