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Launch of Phase III clinical trial for the new macrolide antibiotic “T-4288” in Japan
|December 5, 2016|
Fujifilm Group company Toyama Chemical Co., Ltd. (Head office in Shinjuku-ku, Tokyo; President: Junji Okada; hereinafter “Toyama Chemical”) has announced that it began Phase III clinical trials of the antibacterial agent (macrolide antibiotic) “T-4288” (Generic name: Solithromycin) in Japan.
The drug is a new macrolide antibiotic developed by Cempra, Inc. (Head office in North Carolina; CEO: Prabhavathi Fernandes; Nasdaq: CEMP; hereinafter “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 has submitted new drug applications to the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA), in April and June 2016 respectively, for the treatment of community-acquired bacterial pneumonia.
In May 2013, Toyama Chemical signed a license agreement with Cempra for the exclusive rights to develop, manufacture and market T-4288 in Japan. Following the completion of Phase I clinical trials in Japan, the company commenced Phase II trials in January 2015 and confirmed the efficacy and safety of the drug as a treatment for patients with community-acquired bacterial pneumonia as well as the ability of the drug to migrate to otorhinolaryngological tissues. It enters Phase III clinical trials for patients infected with community-acquired bacterial pneumonia and other respiratory conditions as well as otorhinolaryngological conditions.
With the number of oral antibacterial agent candidates dwindling, and a high level of antibiotic resistance to existing therapies, there is a strong market need for new macrolide antibiotics in Japan. Toyama Chemical is adding this macrolide antibiotic to its existing range of penicillin-type, cephem-type and quinolone-type antibiotics 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.