Lefamulin acetate by Nabriva Therapeutics for Cystic Fibrosis: Likelihood of Approval

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Lefamulin acetate is under clinical development by Nabriva Therapeutics and currently in Phase I for Cystic Fibrosis. According to GlobalData, Phase I drugs for Cystic Fibrosis have a 74% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. GlobalData’s report assesses how Lefamulin acetate’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Lefamulin acetate overview

Lefamulin Acetate (Xenleta) belongs to pleuromutilin and derivatives is an antibiotic drug. It is formulated as film coated tablets for oral and solution for intravenous route of administration. Xenleta is indicated for the treatment of adults with community-acquired bacterial pneumonia (CABP) caused by the following susceptible microorganisms such as Streptococcus pneumoniae, Staphylococcus aureus (methicillin-susceptible isolates), Haemophilus influenzae,Legionella pneumophila, Mycoplasma pneumoniae, Chlamydophila pneumoniae and cystic fibrosis.

Lefamulin (BC-3781) is under development for the treatment of community-acquired bacterial pneumonia (CABP), acute bacterial skin and skin structure infections (ABSSSI) in adults and pediatrics and and LPS induced lung neutrophilia. BC-3781 is a semi-synthetic pleuromutilin antimicrobial agent which is developed as an intravenous and oral therapy. The drug candidate targets 23S rRNA of the 50S bacterial ribosome subunit. The drug candidate was also under development for multi-drug resistant sexually transmitted infections (STIs), including N. gonorrhoeae and M. genitalium, ventilator-associated bacterial pneumonia (VABP), hospital-acquired bacterial pneumonia (HABP), osteomyelitis and prosthetic joint infections.

Nabriva Therapeutics overview

Nabriva Therapeutics (Nabriva) is a biopharmaceutical company that researches and develops antibiotics for the treatment of infections. The company offers product candidates such as Xenleta (lefamulin), CONTEPO (fosfomycin), being developed in both intravenous and oral formulations for the treatment of community-acquired bacterial pneumonia. Its other pipeline products comprise BC-7013 for the topical treatment of a variety of gram-positive infections including uncomplicated skin and skin structure infections and Contepo to treat urinary tract infections. It partners with pharmaceutical and biotechnology companies. It has an operational presence in Austria and the US. Nabriva is headquartered in Dublin, Ireland.

For a complete picture of Lefamulin acetate’s drug-specific PTSR and LoA scores, buy the report here.


GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.

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