Nabriva Therapeutics plc (NASDAQ:NBRV) has announced that XELENTA (lefamulin ) has shown significant efficacy in a posthoc analysis of LEAP 1and LEAP Phase 3 clinical trials by age. XELENTA also showed favorable tolerability and safety profiles in all patient groups that included people aged above 65 who are at risk of CABP morbidity and mortality.
XELENTA shows efficacy in CABP
CABP is among the common causes of infectious death in the US for people aged 65 years and above. The company’s chief medical officer Jennifer Schranz said that people above 65 are at a higher risk of developing CABP because of weakened immunity. Also, age-related comorbidities tend to increase hospitalization chances and CABP-linked complications resulting in functional impairment or mortality. Jennifer added that the post-hoc analysis shows that XELENTA offers an effective and safe empiric monotherapy option to fluoroquinolones for treating CABP in advanced age patients with comorbidities.
In the pooled analysis that considered 1289 participants from LEAP 1 and LEAP 2 trials by age, around 40% of the pooled patients were above 65. When compared to younger participants, the patients above 65 years showed higher pneumonia severity scores. This population was more likely to have cardiac disease, renal impairment, diabetes or asthma/COPD, and hypertension.
XELENTA attacks difficult to treat pathogens in CABP
According to the analysis, the early clinical responses and investigator assessment of clinical response for XALENTA were around 90%. This was the same as that of moxifloxacin, which is the standard of care of fluoroquinolone for CABP across all ages. Most importantly, study drug discontinuation rates and adverse event profiles were the same across all ages.
XELENTA is Nabriva’s first-in-class systemic pleuromutilin antibiotic whose mechanism of action is unique in attacking of difficult to treat pathogens in CABP. It also addresses antibiotic resistance challenges, and so far, it has FDA approval for oral and IV treatment of CABP in adult patients. XELENTA has been designed to inhibit bacterial protein synthesis, which is necessary for the growth of bacteria.