liquid adalimumab delivered by DDS (BT-001) / Biora Therap - LARVOL DELTA

Biora Therapeutics Announces Two Poster Presentations at the Crohn’s & Colitis Congress (GlobeNewswire) - "Biora Therapeutics, Inc...announced acceptance of two abstracts presenting patient data on its targeted therapeutics delivery system for presentation at the Crohn’s & Colitis Congress, which will take place January 19-21, 2023, in Denver, Colorado. This annual conference, a partnership of the Crohn’s & Colitis Foundation and the American Gastroenterological Association, is focused on bringing together a multidisciplinary community of health care practitioners and researchers to transform inflammatory bowel disease care."

Clinical data • Crohn's disease • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Evaluation of the Pharmacokinetics of PGN-OB1 Following Oral Administration of an Oral Biotherapeutics Delivery System (OBDS) in Yucatan Swine (ACG 2022) - "All OBDS capsules were successfully advanced through the pyloric sphincter via endoscopic placement, without early deployment, and released in the proximal duodenum to naturally transit and deploy in vivo . Out of 13 animals dosed, 8 animals showed detectable drug levels (Figure 1), and an oral bioavailability average of 22% or 25% (range from 7-55%) excluding an animal showing a late deployment at 72hr post-dose. The variability in the swine model is believed to be due to physiologic variability that may not directly translate to humans including variability in small intestinal transit time, and more frequent and larger, gas and fluid pockets in the swine."

PK/PD data • Gastrointestinal Disorder

Biora Therapeutics Announces Five Abstracts Accepted at American College of Gastroenterology Annual Scientific Meeting 2022 (Yahoo Finance) - "Biora Therapeutics, Inc...announced the acceptance of five abstracts for presentation at the American College of Gastroenterology (ACG) 2022 Annual Scientific Meeting....The 2022 ACG Annual Scientific Meeting will be held in Charlotte, NC and virtually from October 21–26, 2022....Biora will be presenting results of its device performance studies in healthy volunteers and active UC patients, as well as PK/PD data on enema dosing with adalimumab in active UC patients."

Clinical data • PK/PD data • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Progenity Provides Results from Key Study for Its Targeted Therapeutics Program (GlobeNewswire) - "Progenity, Inc...announced results from a further study for the company’s Targeted Therapeutics program. The study evaluated delivery of Progenity’s PGN-001 (adalimumab) drug substance directly to the colon in a preclinical model of colitis...There was also a significant reduction in TNF-α, the proinflammatory cytokine target of adalimumab, at each of 24 and 48 hours following repeat IC doses when compared with the induced colitis control group that did not receive treatment....'Not only does this support the potential use of PGN-001 as monotherapy but also as combination therapy given the minimal systemic levels and associated safety margin,' said William Sandborn..."

Media quote • Preclinical • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis