Nabriva closes in on bringing new class of antibiotic to market
pharmafile | May 22, 2018 | News story | Manufacturing and Production, Sales and Marketing | Antibiotics, Nabriva Therapeutics, biotech, drugs, pharma, pharmaceutical
Nabriva Therapeutics, a biotech based in Dublin, Ireland, has announced positive Phase 3 data for its antibiotic, lefamulin, which could result in a newly approved antibiotic for doctors to utilise – a type of approval that are few and far between.
The trial was able to show that, on a five-day course of treatment, the antibiotic was non-inferior to current treatment, moxifloxacin. It is the second Phase 3 clinical trial that has shown this result, standing the biotech in good stead for taking the antibiotic through to approval.
The major public health benefit of bringing through a new class of antibiotic is the potential to evade antibiotic-resistance bacteria – a problem that is regarded to be a growing threat to global health at present and in the years to come.
In addition, the five-day treatment cycle is also shorter than the seven-day course recommended for the use of moxifloxacin – meaning that there may be interest in using the antibiotic immediately rather than holding it back for future use.
This has meant that analysts have been happy to suggest that the treatment may well go on to reap peak sales of $500 million to $700 million.
“Coupled with our successful Leap 1 trial, the positive results from Leap 2 suggest lefamulin could be an excellent empiric treatment option for patients with CABP and help address the problem of antibiotic resistance. With these Leap 2 results, we believe there is a significant opportunity for oral lefamulin as a 5-day treatment option for CABP in the community,” said Dr Colin Broom, Chief Executive Officer of Nabriva Therapeutics.
Broom revealed that the company is planning on submitting an NDA in the fourth quarter of this year.
The only minor hiccup in the trial data was the high incidence of diarrhoea suffered by those receiving the antibiotic, with 12% experiencing this side-effect of treatment – only 1% of those on moxifloxacin endured the same side-effects.
However, when speaking on the issue previously, Broom had stressed that diarrhoea is a common side effect of most antibiotics and doesn’t anticipate this to hinder uptake.
Ben Hargreaves
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