Nabriva Therapeutics (NASDAQ:NBRV) has announced that it will embark on the second of the two phase III trials of the antibiotic lefamulin. This study will evaluate the safety and efficacy of the company’s lead product candidate intended for the treatment of the community-acquired bacterial pneumonia (CABP) in adults. The study, Lefamulin Evaluation against Pneumonia (LEAP) 2 is designed to assess oral lefamulin against oral moxifloxacin in moderate CABP cases.
Nabriva Therapeutics AG is a biopharmaceutical company that engages in research and development of the anti-infective agents designed to treat certain infections in humans. The company majors in pleuromutilin class of antibiotics.
Lefamulin is Nabriva’s top candidate product which has already undergone Phase II clinical trials focused on acute bacterial skin as well as skin structure infections. The company is now engaged in the development of intravenous and oral formulations of its lead product. Nabriva plans to develop lefamulin for other indication alongside pneumonia. The Pharmaceutical company also develops BC-7013, a topic pleuromutilin antibiotic which has successfully undergone phase 1 clinical trials. The company is based in Vienna, Austria.
Second phase III Clinical Trials
When initiating the second phase-3 trial, the company aims at meeting the drug development timeline it set after being listed on NASDAQ last September. The initial public (IPO) generated $92 million which was further boosted by a $120 million VC round setting the company aimed to get the trials underway by the first half of this year. With the deadline already met, Nabriva now plans to have the data from the two studies available by the first half of the next year, followed by filling of marketing applications 2018.
The second trial will meet FDA demands and broadens the list of patients whose data Nabriva holds. According to the company’s CEO, Colin Broom, the second study will cater to patients experiencing moderate to severe pneumonia thus broadening their data spectrum.
Should lefamulin hit the market, the company will first focus on the much sicker patients, a move designed to reflect the possible reticence to prescribe the original antibiotics as the last resort.