CARB-X Funds BioVersys
BioVersys’ new medicine would be used as a stand-alone to treat uncomplicated skin and skin structure infections (SSSI) or in combination with antibiotics for more severe infections.
“Drug-resistant bacteria represent one of the greatest threats to public health globally. New approaches, like the BioVersys’ project, are urgently needed to help save lives and to curb the spread of drug-resistant bacteria,” said Kevin Outterson, executive director of CARB-X, which is based at the Boston University School of Law. “This project is in early stages of development but if successful and approved for use in patients, it would represent tremendous progress in the fight against drug resistance, by offering an alternative therapy to traditional antibiotics and also restoring the effectiveness of existing antibiotics.”
Dr. Marc Gitzinger, CEO and cofounder of BioVersys: “We are delighted that CARB-X recognizes the immense potential of BioVersys’ anti-virulence program (BV200) through this funding award. The diversity in the challenge of antimicrobial resistance (AMR) diseases, requires us to broaden our approach beyond classical antibiotics, and further R&D investment in novel paradigm shifting approaches such as anti-virulence is vitally important. BioVersys is committed to continue its development of novel targeted antimicrobials and deliver new treatment options to AMR patients worldwide.”
The BV200 series of molecules has been developed using the company’s TRIC technology (Transcriptional Regulator Inhibitory Compounds). These are not direct acting antibiotics, but rather a new class of molecules, capable of disarming bacteria of their harmful virulence factors. Molecules of the BV200 class inhibit the transcriptional regulator AgrA which controls the production of harmful virulence factors including -toxin, phenol-soluble-modulin (PSM) and Panton-Valentine leucocidin (PVL) toxins that are directly linked to the severity of S. aureus-mediated skin and skin structure infections( SSSIs) and pneumonia. By preventing the expression of toxins, the molecules have the potential to reduce tissue damage, disease progression and, consequently, reduce infection severity and mortality rates in patients. The BV200 series will initially be developed for skin and skin structure infections (SSSI) and pneumonia caused by S. aureus, including Methicillin-resistant S. aureus (MRSA).
MRSA is identified by the World Health Organization (WHO) as Priority drug-resistant bacteria, and as a Serious Threat to public health by the Centers for Disease Control and Prevention (CDC).
Supporting antibacterial innovation
According to the WHO, an estimated 700,000 people die each year worldwide from bacterial infections. In the US, according to the CDC, an estimated 23,000 people die each year from drug-resistant bacterial infections. In Europe, the number of deaths yearly is estimated at 33,000.
CARB-X is investing up to $500 million in antibacterial R&D between 2016-2021, exclusively targeting drug-resistant bacteria identified by the WHO and CDC as posing the greatest health threats. The goal is to support projects through the early phases of development, through Phase 1 for therapeutics, so that they will attract additional private or public support for further clinical development and approval for use in patients. The CARB-X portfolio, the world’s largest antibacterial development portfolio with 30 projects in five countries. Since its inception in 2016, CARB-X has announced 49 awards exceeding $155 million, with the potential of additional funds if project milestones are met, to accelerate the development of antibacterial products. These funds are in addition to investments made by the companies themselves. The CARB-X pipeline will continuously evolve, as projects progress and others fail for a variety of reasons.
CARB-X is led by Boston University and funding is provided by the Biomedical Advanced Research and Development Authority (BARDA), the Wellcome Trust, Germany’s Federal Ministry of Education and Research (BMBF), the UK Department of Health and Social Care’s Global Antimicrobial Resistance Innovation Fund (GAMRIF), the Bill & Melinda Gates Foundation, and with in-kind support from National Institute of Allergy and Infectious Diseases (NIAID).