Biora Therapeutics has submitted an updated investigational new drug (IND) application with the US Food and Drug Administration (FDA) for further development of the company’s drug/device combination, BT-600.
The BT-600 is an ingestible device that contains a liquid formulation of tofacitinib for treating moderate to severe ulcerative colitis (UC). It is designed to deliver the medication directly into the colon.
In September, Biora first submitted the IND application with the FDA for starting a placebo-controlled Phase I trial in healthy volunteers to evaluate the drug/device combination’s safety, pharmacokinetics, and pharmacodynamics.
“Near the end of the review period, the FDA requested additional information on our IND for BT-600 and will need additional time to complete the review of our submission. We plan to address the agency’s questions and submit our updated filing, potentially as early as this week,” said Biora’s chief medical officer Ariella Kelman.
“We continue to have a constructive exchange with the FDA, and while we cannot predict their response, we anticipate remaining on track with our previously communicated execution timeline.”
The IND application contains information on manufacturing, preclinical, human device function, and toxicology data for BT-600.
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The drug delivery device was previously evaluated in an open-label trial and contained a radio-labelled tracer. After injection, Scintigraphy imaging was used to evaluate device localisation and payload delivery to the large intestine. The data from the trial was presented at the American College of Gastroenterology Annual Scientific Meeting in October 2022.
Another drug/device in Biora’s portfolio includes the BioJet biotherapeutic delivery platform, which contains glucagon-like peptide-1 (GLP-1) receptor agonists. It is currently being evaluated in porcine models and the data from these was presented at the 59th annual meeting of the European Association for the Study of Diabetes in Hamburg (Germany) in October 2023.