Key Points

  • The PGN-600 program utilizes the company's Targeted Therapeutics Platform, which aims to deliver drugs specifically to the tissue of the large intestine.
  • Previous studies have shown that achieving the appropriate concentration of the drug tofacitinib in the tissue of the large intestine is correlated with endoscopic improvement.
  • Biora believes that reducing systemic exposure to tofacitinib could be a paradigm shift in the ability to help a substantial percentage of patients with UC.
  • In addition to the PGN-600 program, the company has other promising programs planned for 2023, including a device performance study that could potentially enable non-fasted administration and a Systemic Therapeutics program that could lead to partnerships with pharmaceutical companies.

Biora Therapeutics, a biotech company that specializes in therapeutic delivery, recently received feedback from the United States Food and Drug Administration (FDA) on its clinical development plans for its PGN-600 program, which is focused on treating ulcerative colitis (UC).

The company is on track to file an Investigational New Drug (IND) application with the FDA, followed by clinical trial initiation in the first half of 2023.

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During the fourth quarter of 2022, Biora stock continued its engagement with the FDA by submitting a pre-IND supplemental Type C filing, which requested feedback on its proposed PGN-600 clinical development plans, including the company's proposed approach to toxicity studies and other aspects of its clinical plan. The FDA's recent Type C response further strengthened Biora's confidence in its plans to move forward with its PGN-600 program, as it strengthens the company's ability to initiate a clinical trial.

The PGN-600 program utilizes the company's Targeted Therapeutics Platform, which aims to deliver drugs specifically to the tissue of the large intestine. According to the company, previous studies have shown that achieving the appropriate concentration of the drug tofacitinib in the tissue of the large intestine is correlated with endoscopic improvement.

Biora believes that reducing systemic exposure to tofacitinib could be a paradigm shift in the ability to help a substantial percentage of patients with UC.

Biora Therapeutics also has other programs in the pipeline for 2023, including a device performance study for its Targeted Therapeutics program, which could potentially enable non-fasted administration in patients, and a Systemic Therapeutics program, which the company hopes to partner with next-phase pharmaceutical companies.

Biora Therapeutics is on track to move forward with its PGN-600 program for treating ulcerative colitis in 2023, following positive feedback from the FDA. The company also has other promising programs planned for the year, including a device performance study that could potentially enable non-fasted administration and a Systemic Therapeutics program that could lead to partnerships with pharmaceutical companies. The potential impact on patient care for ulcerative colitis from these program is expected to be significant.



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About BIORA THERAPEUTICS, INC.


  • Ticker BIOR
  • Exchange NASDAQ
  • Shares Outstandng 186,623,605
  • Market Cap $116M
  • Description
  • Biora Therapeutics, Inc., a biotechnology company, engages in developing oral biotherapeutics. The company's targeted therapeutics program uses an ingestible smart capsule for targeted delivery of therapeutics in the gastrointestinal (GI) tract to enhance the treatment of inflammatory bowel diseases; and systemic therapeutics program uses an ing...
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