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Efficacy and safety of the new macrolide antibiotic “T-4288” confirmed in Phase II clinical trial in Japan
|May 26, 2016|
Fujifilm Group company Toyama Chemical Co., Ltd. (Head office in Tokyo; President: Masuji Sugata; “Toyama Chemical”) 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 Cempra, Inc. (Head office in North Carolina; CEO: Prabhavathi Fernandes; “Cempra”; Nasdaq: CEMP). 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 U.S. 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 Cempra for 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.
【Result】・The clinical success rate of the ITT population *1 was 77.3% (34 out of 44 cases) and 72.7%(32 out of 44 cases) for T-4288 recipients of QD and BID group respectively. The clinical success rate of the PPS population *2 was 85% (34 out of 40 cases) and 77.5% (31 out of 40 cases) for T-4288 recipients of QD and BID group respectively.
[The clinical success rate of the ITT and PPS population with levofloxacin, the reference drug*3, was 61.7% (29 out of 47 cases) and 67.4% (29 out of 43 cases) respectively. Levofloxacin recipients received 500 mg once a day for 5 days. ]
・No serious side effect with clinically significant concern was observed.
This Phase II clinical trial has confirmed T-4288’s efficacy and safety. The company will start preparing for the Phase III trial.
With the number of oral antibacterial agent candidates dwindling, there is a strong market need for new macrolide antibiotic in Japan. Toyama Chemical is adding the macrolide antibiotic to the existing range of penicillin type, cephem type and quinolone type antibiotic to enhance its lineup in the field of infectious diseases.
Toyama Chemical, a subsidiary of FUJIFILM Holdings Corporation, specializes in pharmaceutical research and development, and strives to “contribute to the further development of global health care through new drug development”.
*1In the population of patients with community-acquired pneumonia who were given the study drug or the reference drug, the percentage have shown clinical response at Test of Cure