Basic and clinical studies on NM441 in respiratory infection

We performed basic and clinical studies on a new quinolone antibiotic, NM441, and the following results were obtained. 1) Antimicrobial activity: The minimum inhibitory concentrations (MICs) of NM394, an active form of NM441, against a total of 362 clinical isolated strains of 13 species were measured and compared with those of other 4 drugs (ofloxacin, ciprofloxacin, tosufloxacin and sparfloxacin). 2) Concentrations in serum and sputum: NM441 was administered to 1 patient with pneumonia at a dose of 200mg once, and the serum and sputum concentrations of NM394 were measured by HPLC method. The maximum serum concentration was 0.61μg/ml at 2h and 4h after administration, and the maximum sputum concentration was 1.21μg/ml at 4~6h after administration. These results suggested the favorable penetration of NM441 into lungs. 3) Clinical study results: NM441 was administered to 16 patients with respiratory infections, and its clinical efficacy, bacteriological efficacy and side effects were investigated. Clinical response was excellent in 3 cases, good in 12 and poor in 1, and the efficacy rate was 93.8%, showing a favorable response. As for side effects and abnormal laboratory findings, eruption in 1 case, nausea in 1 and increase of eosinophil in 1 were observed. However, all of these cases improved immediately after termination of NM441 treatment, and the safety of NM441 was confirmed.