Nabriva Raises $120 Million, Headed to Phase III for New Antibiotic
April 7, 2015
By Mark Terry, BioSpace.com Breaking News Staff
The development of new antibiotics is quite rare. Nabriva Therapeutics AG, with headquarters in Vienna, Austria and King of Prussia, Penn., announced today that it had completed a $120 million Series B financing round. The initial tranche of $50 million will be used to take the company’s lead product, lefamulin, into Phase III clinical trials.
Nabriva Therapeutics focuses on pleuromutilin antibiotics. The company’s lead product, lefamulin (BC-3781), is the first systemic pleuromutilin available for human use. It is entering a Phase III trial for the treatment of community-acquired bacterial pneumonia (CAPB).
Pleuromutilins were discovered in 1950 and were first approved for veterinary use in 1979. The first pleuromutilin approved for humans was retapamulin in 2007, but was limited to topical application. Pleuromutilins inhibit bacterial protein synthesis by binding to unique sites on part of the ribosome. They are noted to have two advantages: low potential for cross-resistance with other antibacterial classes, and low potential for bacteria to develop resistance.
“We are delighted to have attracted investment from some of the world’s leading healthcare investors,” said Colin Broom, chief executive officer of Nabriva in a statement. “It is validation of Nabriva’s approach in developing the pleuromutilin antibiotic class, which has a unique mechanism of action thereby helping to combat the current and evolving emergence of resistance to currently available antibiotics.”
On Oct. 8, 2014, the company announced that the U.S. Food and Drug Administration (FDA) had granted Qualified Infectious Disease Product (QIDP) and Fast Track status to lefamulin for the treatment of CAPB and acute bacterial skin and skin structure infections (ABSSSI). The Fast Track program provides expedited review. The QIDP designation gives an additional five years of market exclusivity for antimicrobials that are developed to treat serious and life-threatening infections.
Nabriva has at least five pleuromutilin compounds in its pipeline that range from preclinical to Phase II studies. In addition to CABP, lefamulin is being looked at for hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP), and ABSSSI. Others are being looked at for eye and wound infections, SSSI, complicated urinary tract infections (cUTI), and complicated intra-abdominal infections (cIAI).
“The rapid spread of multi-drug resistance is a growing public health threat recognized by global policy makers as governments commit resources and funding to tackle this problem,” said Denise Pollard-Knight, chair of the supervisory board of Nabriva in a statement. “The development of novel antibiotics with a unique mechanism of action against these pathogens is critically important in developing a new generation of drugs. This Series B is a strong financial and scientific endorsement and provides Nabriva with a solid foundation to build a patient-centric global biopharmaceutical company.”
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