Next-generation Cempra antibiotic meets endpoints
pharmafile | January 5, 2015 | News story | Research and Development, Sales and Marketing | Antibiotics, FDA, cempra, moxifloxacin, solitaire-oral
Cempra Pharmaceuticals has become the first company to publish results from a Phase III study completed under FDA regulations governing how new antibiotics are developed.
The US company announced that its antibiotic Solitaire-Oral (solithromycin), a treatment for community-acquired bacterial pneumonia (CABP), met its primary and secondary endpoints in a trial comparing it with the antibiotic moxifloxacin.
This study was the first to be completed under the FDA’s proposed guidance for developing new CABP treatments, which allows pharma companies to conduct clinical trials for these drugs using more relaxed statistical margins.
The study included 860 adult patients with moderate to moderately severe CABP who received either Solitaire-Oral or oral moxifloxacin. The primary endpoint was statistical non-inferiority – a statistical way of demonstrating that a new drug is not clinically worse than an existing treatment – with respect to the number of people who responded to treatment in the first 72 hours.
The secondary endpoints included the clinical success rate at five to 10 days following the last dose of treatment.
After 72 hours 78.2% of patients on Solitaire-Oral and 77.9% of patients on moxifloxacin had shown a positive clinical response, with the lack of significant different between the two treatments demonstrating that Solitaire-Oral is statistically non-inferior to moxifloxacin.
The results for the secondary efficacy endpoints supported the results from the primary endpoint. Serious adverse events occurred with equal frequency in both arms (< 7% of patients). None were considered to be related to the treatments.
Solitaire-Oral is the first treatment in a new generation of macrolide antibiotics, called fluoroketolides, designed for use against most strains of bacteria that have already shown resistance to other macrolides and azithromycin. Its mode of action is expected to prevent the development of resistance to Solitaire-Oral, the company says.
Prior-generation macrolides have triggered safety concerns. In the past Sanofi’s Ketek (telithromycin) has been associated with liver toxicity, and azithromycin has been linked with an increased risk of heart problems.
North Carolina-based Cempra is an independent company focussed on developing new treatments to combat resistance to older antibiotics. While other specialist pharma companies have been acquired by industry giants, Cempra says it plans to remain a standalone company.
Along with additional ongoing studies with Solitaire-Oral, chief executive Prabha Fernandes has said the company may be open to acquiring other drugs after filing regulatory applications for Solitaire-Oral.
Lilian Anekwe
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