Updated on 1 June 2016
Fujifilm Group's Toyama Chemical Co Ltd has announced the result of its phase II clinical trial of 'T-4288' (solithromycin) on community-acquired pneumonia patients in Japan confirming its efficacy and safety.
The drug is a new macrolide antibiotic created by North Carolina's Cempra Inc. It shows strong antibacterial activity on bacterial pneumonia and mycoplasma resistant to existing macrolide agents, and demonstrates a relatively high level of immunoregulatory activity (anti-inflammatory activity). In the United States, Cempra submitted a New Drug Application for its approval with the US Food and Drug Administration (FDA) for the indication of community-acquired bacterial pneumonia in April 2016.
In May 2013, Toyama Chemical signed a license agreement with Cemprafor the exclusive rights to develop, manufacture and market T-4288 in Japan. The company completed Phase I clinical trial and commenced Phase II trial in January 2015, covering community-acquired pneumonia patients to examine T-4288's efficacy, pharmacokinetics and safety in repeated oral administration for 5 days.
T-4288 recipients received 800 mg on the first day, either as a single dose (QD group), or in divided doses (BID group), and 400 mg as a single dose on Days 2-5.