Cempra announced published results from the Phase 3 study of solithromycin, evaluating an intravenous-to-oral switch for the treatment of community-acquired bacterial pneumonia (CABP) in the journal Clinical Infectious Diseases.
The Phase 3 study, SOLITAIRE-IV, is a randomized, double-blind, multicenter trial comparing the efficacy and safety of the intravenous-to-oral switch of solithromycin vs. intravenous-to-oral moxifloxacin in patients with CABP. The primary endpoint was non-inferiority (10% margin) of solithromycin to moxifloxacin in achievement of early clinical response (ECR) 3 days after first dose.
The trial met its primary endpoint, demonstrating non-inferiority of solithromycin to moxifloxacin for the treatment of CABP. In patients treated with solithromycin, 79.3% achieved ECR vs. 79.7% in the moxifloxacin-treated group (treatment difference: –0.46; 95% CI: –6.1, 5.2). Overall adverse events were comparable between the treatment groups, however, solithromycin was found to have a higher incidence of mild to moderate infusion-related adverse events.
If approved, solithromycin has the potential to provide a new, potent monotherapy option for the treatment of CABP with the ability to transition from IV to oral formulation.
Solithromycin, the first fluoroketolide, is a highly potent next-generation macrolide with in vitro and in vivo activity against S. pneumonia, community-acquired methicillin resistant S. aureus (CA-MRSA), haemophilus, enterococci, Mycobacterium avium, gonococci, and atypical bacteria (eg, legionella, chlamydia, mycoplasma and ureaplasma). It is 8–16 times more potent than azithromycin against many bacteria and has activity against most macrolide-resistant strains.
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