Assembly’s microbiome therapeutics program is initially focusing on developing curative treatments for recurrent C. difficile infection (CDI). It aims to achieve the efficacy of fecal microbiota transplantation (FMT) using an orally-delivered biotherapeutic in a capsule that is developed, manufactured, prescribed and dosed in a way similar to a conventional pharmaceutical therapy.

Assembly’s first microbiome therapeutic, AB-M101, is designed to cure recurrent CDI using its orally-administered Gemicel® capsule to deliver systematically-selected cGMP-manufactured live bacteria strains to the regions of the lower GI tract where CDI pathogens reside. The company is planning to initiate clinical trials in recurrent CDI patients in the second half of 2016.

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CDI is an increasingly common disease of the GI tract caused by the overgrowth of Clostridium difficile (C. difficile) bacteria in the lower GI tract. C. difficile is a resident anaerobic gram-positive bacterium whose overgrowth is usually caused by the use of antibiotics for the treatment of common infections, often in hospitalized patients. The antibiotics used to treat the initial infection can result in disruption of the natural checks and balances of the beneficial bacteria that reside in the healthy gut. This can allow pathologic overgrowth of C. difficile. Under these conditions, C. difficile produces toxins that can lead to severe diarrhea, sepsis and even death.

Infections caused by C. difficile are at historically high levels. According to the Centers for Disease Control (CDC), there was more than a five-fold increase in CDI-associated deaths in the US in the first decade of the 21st century. An estimated half million new CDI cases occur in the US each year, resulting in a longer hospital stay in 55% of cases, a 77% higher chance of readmission to the hospital within 30 days, and a 13% higher risk of mortality. In addition to the human toll, C. difficile generates an estimated $1 billion or more in excess health care costs annually. FMT from healthy individuals have effectively eradicated recurrent CDI in some patients, but FMT involves logistical, production, safety, regulatory, medical and aesthetic issues that limit its use.