Physician Views: Can Nabriva carve out an opportunity for its novel antibiotic lefamulin?

Despite positive data from a second Phase III study announced this week, investors in Nabriva Therapeutics are sceptical (see ViewPoints: Nabriva loses ground, even with a second Phase III win). The main concern is that gastrointestinal side effects could limit commercial opportunity for lefamulin as a first-line treatment for community-acquired bacterial pneumonia (CABP), assuming it is approved by regulators.

We are snap-polling infectious disease specialists (in the US and EU5) to get a better idea of whether these fears are founded or not, with the following questions…

Are you based in a hospital or community setting?

Hospital

Community

In the Phase III LEAP 2 trial, 783 adults with CABP were randomly assigned to treatment with twice-daily oral lefamulin for five days or once-daily oral moxifloxacin for seven days.

Early clinical response between 72 hours and 120 hours after study initiation in the ITT population was 90.8 percent for both lefamulin and moxifloxacin. In addition, the IACR rates in the modified ITT population were 87.5 percent for lefamulin and 89.1 percent for moxifloxacin, while the rates in the clinically evaluable at test of cure patient population were 89.7 percent and 93.6 percent, respectively.  

How do you rate this efficacy data for lefamulin?

Poor

Fair

Good

Very good

Excellent

In the Phase III LEAP2 trial, 12.2 percent of patients given lefamulin suffered from diarrhoea/loose stools, versus 1.1 percent for moxifloxacin, while rates of nausea in the two groups were 5.2 percent and 1.9 percent, respectively. In addition, 3.3 percent of patients given lefamulin experienced vomiting, compared to 0.8 percent for moxifloxacin.

How do you rate this safety data for lefamulin?

Poor

Fair

Good

Very good

Excellent

Taking onto account these data and positive results from an earlier Phase III trial, in which intravenous (IV) to oral lefamulin was found to be non-inferior to IV to oral moxifloxacin with or without linezolid, do you think lefamulin is well suited as a first-line therapy for CABP and will help address the problem of antibiotic resistance?

Strongly disagree

Disagree

Neither agree or disagree

Agree

Strongly agree

And if approved speed of adoption of lefamulin would be…

Very slow

Slow

Moderate

Fast

Very fast

Results and related analysis will shortly be published for FirstWord Pharma PLUS subscribers to read, with the opportunity for non-FirstWord Pharma PLUS subscribers to purchase these findings. To be notified when poll results and analysis become available, please click here.

As always, FirstWord would very much like to receive your feedback and suggestions. Note: FirstWord Polls are powered by Medefield MedePolls, a fast-turnaround service to conduct instant polls of up to five questions with guaranteed samples that include physicians from dozens of specialties and over 100 markets. To conduct this poll with a different audience, or an entirely different poll, contact us at info@firstwordpharma.com.

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