Cempra Inc (NASDAQ:CEMP) has announced positive results from the third phase study of the oral fusidic acid that was conducted in 716 patients suffering from acute bacterial skin and skin structure infections (ABSSSI). Cempra Inc is a clinical-stage medical company mainly engaged in development of anti-infectives to meet acute medical and cure of infectious diseases.
Patients examined in the study tolerated the Fusidic acid and achieved the primary endpoint. This shows the non-inferiority of the acid in comparison to linezolid for early clinical response.
The research involved 62 sites in the U.S. Randomly selected patients were subjected to the oral fusidic acid received. The patient were given a dose of 1500 mg for every 12 hours.
From the study, primary endpoint was the number of patients alive less the baseline in size of lesion for a period of between 48 to 72 hours. 87.2 percent of ITT undergoing fusidic acid treatment showed ECR as compared to 86.6 percent of ITT undergoing linezolid treatment. This shows the non-inferiority of the linezolid
Fusidic acid also showed high levels of efficacy compared to linezolid. Both treatments showed high Microbiological response rates in microbiologically-evaluable patients and microbiological ITT. Staphylococcus aureus, Streptococcus anginosus was the most identified pathogen. Fusidic acid showed a 100% success rate in all patients with methicillin-resistant S. aureus (MRSA) infection. All treatment groups showed a comparable treatment-emergent adverse events (TEAE) rate. The most prevalent TEAEs in both groups were gastrointestinal with 22.8 percent fusidic acid and 18.2 percent linezolid. Serious adverse events (SAEs) were reported in six patients administered with fusidic acid and eight patients administered with linezolid. These adverse occurrences let to discontuation in study drug in 2.2% of patients administered with fusidic acid and 2% percent of patients administered with linezolid. 1.0% of patients on administered with fusidic acid and 0.7 of patients administered with linezolid showed rates of treatment elevation. One patient died during the study due to overuse of illicit drugs and aspiration which was reported in a patient receiving linezolid.