Biora Therapeurics is preparing an ulcerative colitis therapy. Credit: Emily frost via Shutterstock.

The US Food and Drug Administration (FDA) cleared Biora Therapeutics’s investigational new drug (IND) application for its ulcerative colitis (UC) combination therapy BT-600.

The company submitted an updated IND application for the upcoming Phase I trial in October, providing supplemental information.

Following this announcement, the US-headquartered company will proceed with a Phase I trial to investigate the drug. The randomised, double-blind, placebo-controlled will test the drug at 5mg and 10mg doses.

BT-600 is a Janus kinase (JAK) inhibitor to treat moderate to severe UC. The therapy uses a liquid formulation of Pfizer’s Xeljanz (tofacitinib) with Biora’s NaviCap ingestible drug delivery device. NaviCap is an oral administration that uses an ingestible smart capsule to deliver therapeutics to the large intestine to treat inflammatory bowel disease (IBD), first focusing on UC.

The biotech is also currently using NaviCap in its clinical development programme for BT-001, another UC therapy. This drug combines the NaviCap technology with an adalimumab variant. Additionally, Biora Therapeutics is also developing its BioJet platform for “oral systemic delivery of biotherapeutics”, as per the company’s website. The system can be ingested, so it can then deliver drugs to the small intestine via liquid jet delivery.

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UC is an autoimmune condition that causes the rectum to become inflamed, causing symptoms such as recurring diarrhoea and stomach pain. In 2023, it is estimated that five million individuals are affected by the disorder worldwide.

In October 2023, the FDA approved Eli Lilly’s Omvoh (mirikizumab) to treat moderately to severely active UC in adults, after a previous rejection in April. The agency cited its reason for withholding approval as manufacturing concerns, as per a 13 April press release.

In a 30 November press release, Dr. Ariella Kelman, chief medical officer at Biora Therapeutics said: “We look forward to completing the activities required by FDA and the trial site prior to enrolling the first subject in our Phase I clinical trial in the United States in the coming weeks.”