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IDRI to continue development of inhalable TB drug candidate

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IDRI (Infectious Disease Research Institute), on behalf of the Lilly TB Drug Discovery Initiative, announces it has entered into an agreement with Zhejiang Hisun Pharmaceutical Co., Ltd., a China-based leading biopharmaceutical company, to continue development of inhalable CPZEN-45, a tuberculosis (TB) drug candidate that could potentially treat the growing problem of antibiotic-resistant TB. Burdening its victims with increased health concerns and a high cost of treatment, drug-resistant TB occurs when Mycobacterium tuberculosis (Mtb), the bacterium that causes TB, becomes resistant to the drugs used to treat it, underscoring the need for the development of new drugs.

The Lilly TB Drug Discovery Initiative is a unique public-private partnership founded in 2007 by IDRI, Eli Lilly and Company and the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). Its focus is on the discovery of new anti-tuberculosis drugs.

Hisun and IDRI will work together to further develop CPZEN-45, an antibiotic that has a new mechanism of action that inhibits cell wall synthesis — the 'Achilles Heel' of Mtb — and has shown efficacy against both drug sensitive and multidrug (MDRTB) and extensively drug resistant (XDRTB) TB. CPZEN-45 was discovered by the Institute of Microbial Chemistry (IMC), a nonprofit research institute located in Tokyo, Japan.

"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," said Masakatsu Shibasaki, Director of IMC and former President of the Pharmaceutical Society of Japan.

In 2008, IMC joined The Lilly TB Drug Discovery Initiative to collaborate on further studies for developing this candidate drug.

"Critical research and development milestones have already been achieved with CPZEN-45, making it a late-stage pre-clinical candidate with enormous potential, due to the outstanding expertise of our scientific colleagues at IMC and the RTI International (RTI) and resources provided by NIAID," said Steve Reed, President, CEO and Founder of IDRI.

"IMC has made important contributions to scale up the production of this molecule," said Gail Cassell, Executive Vice President of TB Drug Development, IDRI. "Now, we are pleased to partner with Hisun, which is one of the few companies in the world that has the expertise to scale this drug to commercial level and provide us with GMP quality material for further development and clinical trials. The real value of this relationship is clinical data with the sought-after result being a validated drug that can improve health and stop the tide of drug-resistant TB."

Bai Hua, Chairman of Hisun and Vice Chairman, China Pharmaceutical Industry Association, added, "We are excited to team up with world-class scientists to combat drug-resistant TB. I hope CPZEN-45 will soon be added to Hisun's portfolio of other anti-TB drugs, including WHO approved capreomycin."

Through its relationship with Hisun, IDRI will continue developing CPZEN-45 alone and in combination with capreomycin, a drug discovered in 1960 that is frequently used to treat TB infections.

"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," said Anthony Hickey, Distinguished Fellow of RTI International and an expert on delivery of inhaled pharmaceuticals. "The product is designed to meet regulatory standards to support a Phase I clinical trial. 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."

In 2015, an estimated 10.4 million people worldwide developed TB and TB surpassed HIV as the leading infectious cause of death worldwide, with 1.8 million deaths, more than HIV/AIDS and malaria combined. MDR-TB as well as a growing number of XDR-TB cases have been reported in nearly all countries. Worldwide emergence of MDR/XDR-TB threatens global eradication of TB.

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About IDRI: As a nonprofit global health organization, IDRI (Infectious Disease Research Institute) takes a comprehensive approach to combat infectious diseases, combining the high-quality science of a research organization with the product development capabilities of a biotech company to create new diagnostics, drugs and vaccines. Founded in 1993, IDRI has 125 employees headquartered in Seattle with nearly 100 partners/collaborators around the world. For more information, visit http://www.idri.org.

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Lee Schoentrup
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http://www.idri.org

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