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Launch of Phase II clinical trial for the new antibacterial agent (macrolide antibiotic) “T-4288” in Japan
|January 14, 2015|
Fujifilm Group company Toyama Chemical Co., Ltd. (Head office in Shinjuku-ku, Tokyo; President: Masuji Sugata; “Toyama Chemical”) has announced that it began Phase II clinical trial of the antibacterial agent (macrolide antibiotic) “T-4288” (Solithromycin) in Japan.
The drug is a new antibacterial agent (macrolide antibiotic) created by Cempra, Inc. (Head office in North Carolina; CEO: Prabhavathi Fernandes; “Cempra”). 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). Cempra’s Global Phase III clinical trial in moderate to moderately-severe community-acquired pneumonia patients began in December 2012. Cempra has also completed a Phase 1a pediatric trial.
On May 8, 2013, Toyama Chemical signed a license agreement with Cempra for the exclusive rights to develop, manufacture and market “T-4288” in Japan. The company began Phase I clinical trial in Japan in September 2013 to confirm the drug’s safety and tolerability. Phase II clinical trial, announced today, is carried out on patients with community-acquired pneumonia to examine the efficacy, pharmacokinetics and safety of “T-4288” in repeated oral use.
With the number of oral antibacterial agent candidates dwindling, there is a strong market need for new antibacterial agent (macrolide antibiotic) in Japan. Toyama Chemical is adding the antibacterial agent (macrolide antibiotic) to the existing range of penicillin type, cephem type and quinolone type antibacterial agent 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”.