US-based pharmaceutical firm Cempra has reported positive topline results from a global, pivotal Phase III clinical trial of solithromycin oral capsules (Solitaire-Oral) in the treatment of patients with community acquired bacterial pneumonia (CABP).
Cempra said that in the intent-to-treat population (ITT, all randomised patients), solithromycin met the primary objective of statistical non-inferiority of the early clinical response at 72 hours after the start of therapy, compared to moxifloxacin.
The drug also met secondary objectives of non-inferiority in clinical success at the short term follow up (SFU) visit, five to ten days after the end of therapy, both in the ITT and clinically evaluable populations.
Results were similar in the combined total patient population, while analysis of initial sub-groups by age, show that the difference in point estimates became larger with increasing age and favoured solithromycin in the ITT early clinical response groups.
According to the company, results for secondary efficacy endpoints supported results from the primary endpoint.
The trial was the first to be completed under proposed US Food and Drug Administration (FDA) CABP guidance, which allows evaluation of the new primary endpoint of early clinical response in the pooled mITT population (ITT population with microbial isolates) across two similar Phase III trials, using a 12.5% non-inferiority margin.
Cempra president Prabhavathi Fernandes said: "I congratulate Dr David Oldach, senior vice-president of Clinical Research, his clinical group and the entire Cempra team for running this landmark oral study, which has produced these positive efficacy results for the Solitaire-Oral clinical trial, the first of our two pivotal Phase III studies for solithromycin."
"The management of CABP remains a challenge for healthcare providers and I believe solithromycin has the potential to be a rational option for the treatment of this life threatening illness.
"Our Phase III Solitaire intravenous study continues to enroll patients as planned."
The double-blind, active-controlled global, multi-centre Phase III Solitaire-Oral trial enrolled 860 adult patients with moderate to moderately severe CABP (pneumonia of PORT Class II, III and IV severity classification).
In December 2013, the company started the second Phase III trial of solithromycin, Solitaire-IV, a randomised, double-blind, active-controlled, multi-centre global study that will enroll 800 patients with PORT Class II, III and IV CABP.