BioVersys’ preclinical candidate BV100 has been granted the Qualified Infectious Disease Product (QIDP) designation from the U.S. FDA. The preclinical drug candidate BV100 is being developed for the treatment of various bacterial pneumonia and bloodstream infections. Under the QIDP program, BioVersys will receive preferential treatment for the development of BV100.
The Basel based BioVersys is multi-asset Swiss pharmaceutical company focusing on research and development of small molecules for multidrug-resistant bacterial infections with applications in Anti-Microbial Resistance (AMR) and targeted microbiome modulation.
One of its drug candidates is BV100, a narrow spectrum compound with exceptional in vitro and in vivo antimicrobial activity on Acinetobacter baumannii. The candidate is being developed for the treatment of multidrug-, extensively drug and pandrug-resistant (MDR, XDR & PDR) ventilator-associated bacterial pneumonia (VABP) and hospital-acquired bacterial pneumonia (HABP) infections.
Today, BioVersys announced the receipt of the QIDP Designation from the U.S. FDA for the development of BV100. Under the QIDP program, BioVersys will get certain incentives for the development of BV100, such as eligibility for priority FDA review, Fast Track designation, and a five-year extension of market exclusivity will be granted upon approval of the first QIDP indication for BV100.
The FDA’s QIDP designation brings BioVersys closer to the clinical stage. Acknowledging this regulatory milestone, the startup team now looks forward to working with the FDA to rapidly develop its potent antibiotic compound and make it available to people suffering from life-threatening multidrug-resistant Acinetobacter infections.
“The receipt of QIDP designation from the FDA is an important step forward and validation of BioVersys’ continued commitment to developing innovative and potentially life-saving AMR treatments, in a field where we have a lack of truly novel therapeutic options and an exceptionally high unmet medical need”, said Marc Gitzinger, CEO and co-founder of BioVersys.
In line with the latest announcement, BioVersy also revealed that its most advanced compounds for nosocomial infections and Tuberculosis will enter the first Phase I clinical trials in H1 2020. These compounds were developed in collaboration with GlaxoSmithKline (GSK) and a consortium of the University of Lille.
(Press release/ran)
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