Assembly Biosciences Reports Successful Clinical Study on Gemicel

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Assembly Biosciences reported a successful clinical study validating the use of the Gemicel technology platform for the oral delivery of biologic medications.

On Dec. 9, 2015, Assembly Biosciences, Inc., a biotechnology company focused on developing treatments for hepatitis B virus and Clostridium difficile infections (CDI), reported a successful clinical study validating the utility of the oral Gemicel technology platform.

The study demonstrated that Gemicel effectively released a bolus therapeutic payload to specific portions of the lower gastrointestinal (GI) tract. The data were generated in three clinical cohorts that used radioisotope-based scintigraphy to precisely image the drug delivery properties of Gemicel in healthy volunteers. Detailed study results will be presented at a scientific meeting early next year.

Gemicel is a dual-release system designed to enable oral targeted delivery of biologics-including microbiota such as vegetative bacteria and bacterial spores, vaccines, genetic materials, and small molecules-to the lower gastrointestinal (GI) tract. Assembly is initially developing Gemicel as a delivery platform for selected bacteria strains to replace fecal microbiota transplants (FMT) as a treatment for resistant C. difficile infections. The company is planning to initiate a Phase lb clinical trial for the treatment of recurrent CDI in the second half of 2016.

“For microbiome-modifying CDI therapies to achieve their potential, the intended dose needs to be reliably delivered to the specific portion of the GI tract where CDI occurs. Yet the GI tract poses many challenges for drug delivery, especially for large and complex molecules such as therapeutic microbes and other biologics,” said Mohan Kabadi, PhD, vice-president of Pharmaceutical Development at Assembly, and co-creator of Gemicel. “Our Gemicel technology was designed to overcome these barriers in an orally-administered drug product format. These clinical scintigraphy studies confirm that our oral capsule approach works as planned, delivering its therapeutic payload to the sites in the GI tract most relevant to the treatment of CDI.”


The company will present data from the study at the 5th Drug Formulation, Solubility and Bioavailability Summit in Philadelphia, PA from January 25-27, 2016. 

Source: Assembly Biosciences