The Infectious Disease Research Institute (IDRI) said today it has partnered with Zhejiang Hisun Pharmaceutical (Hisun) to continue development of a late preclinical tuberculosis (TB) drug candidate that has shown potential for treating antibiotic-resistant TB.

The value of the partnership was not disclosed.

CPZEN-45 is an inhalable nucleoside antibiotic that according to IDRI has shown efficacy against both drug-sensitive and multidrug-resistant (MDR) TB and extensively drug-resistant (XDR) TB. CPZEN-45 was discovered by the Institute of Microbial Chemistry (IMC), a nonprofit research institute located in Tokyo, Japan. CPZEN-45 is designed to work by inhibiting cell wall synthesis in Mycobacterium tuberculosis (Mtb), the bacterium that causes TB. 

“In 2003, when we were exploring derivatives of the caprazamycin family, which are liponucleoside antibiotics, we were surprised to find that the mode of action of CPZEN-45 was different from the parent compounds, and thus we were quite excited about this compound,” Masakatsu Shibasaki, Ph.D., director of IMC and former president of the Pharmaceutical Society of Japan, said in a statement.

Five years later, IMC teamed up with The Lilly TB Drug Discovery Initiative to collaborate on further studies for developing this candidate drug. The Lilly TB Drug Discovery Initiative is a public–private partnership founded in 2007 by IDRI, Eli Lilly and Company, and the NIH’s National Institute of Allergy and Infectious Diseases (NIAID).

According to the Working Group on New TB Drugs, data generated by NIAID using the interferon-γ gene-disrupted mouse model of acute tuberculosis—in which infection was achieved by aerosol exposure to Mtb—has shown the efficacy of CPZEN-45 with 1–1.5 log colony-forming units (cfu) reduction in lungs of infected mice. CPZEN-45 has also shown efficacy against both MDR and XDR Mtb in a mouse model of acute TB in which animals were infected by intravenous injection and treated with subcutaneous administration of CPZEN-45.

IDRI and Hisum said they plan to continue developing CPZEN-45 alone and in combination with capreomycin, a drug often used to treat TB infections.

“Critical research and development milestones have already been achieved with CPZEN-45, making it a late-stage preclinical candidate with enormous potential, due to the outstanding expertise of our scientific colleagues at IMC and RTI International and resources provided by NIAID,” added Steve Reed, Ph.D., IDRI’s president, CEO, and founder.

Anthony Hickey, Ph.D., distinguished fellow of RTI International, whose research has specialized in delivery of inhaled pharmaceuticals, stated that a combination of capreomycin and CPZEN-45 has been prepared as a spray-dried powder for delivery as an aerosol using a commercially available device.

“The product is designed to meet regulatory standards to support a Phase I clinical trial,” Dr. Hickey said. “We believe that the use of aerosols offers a new and effective way of modifying the current approach to treat TB and can potentially shorten the time of treatment.”








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