Biopharmaceutical company BioVersys has announced the grant of key patent claims in China for BV100, the intravenous formulation of rifabutin.
The technology is being developed to combat resistant hospital infections caused by the Acinetobacter baumannii-calcoaceticus complex, including carbapenem-resistant strains (CRAB).
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BioVersys highlighted the urgent need for safe treatments for CRAB infections, which can have death rates in hospitals as high as 50%.
According to recent epidemiology data, the company estimates that more than one million individuals in China suffer from severe CRAB-related pneumonia and bloodstream infections every year.
BV100’s mode of action enables rifabutin’s “active uptake” into the Gram-negative bacterial species Acinetobacter baumannii, targeting the ribonucleic acid (RNA)-polymerase enzyme.
It is under development for treating ventilator-associated bacterial pneumonia (VABP), hospital-acquired bacterial pneumonia (HABP), and bloodstream infections (BSI).
BioVersys CEO Dr Marc Gitzinger said: “With the addition of China, we now have patents protecting BV100 granted in all the major markets, covering more than 25 countries. In our commitment to bring BV100 as a life-saving medicine to patients as fast as possible, this addition to our patent coverage is key due to the absolute number of patients affected by Acinetobacter infections in China.
“We are preparing to start a Phase I clinical trial in China soon, which will enable us to include China in our BV100 Phase III registration trial, which is planned to start in H2 2025.”
In May 2019, the US Food and Drug Administration (FDA) granted the candidate qualified infectious disease product (QIDP) designation for VABP, BSI, and HABP, which paved the way for fast-track designation, priority review, and a five-year market exclusivity extension on approval of the initial QIDP indication.
Last May, BioVersys and GSK announced the expansion of their strategic collaboration to expedite the clinical development of alpibectir (BVL-GSK098) for tuberculosis treatment.
