liquid tofacitinib delivered by DDS (BT-600) / Biora Therap - LARVOL DELTA

BT-600-101: BT-600 Single and Multiple Ascending Oral Doses in Healthy Adult Subjects (clinicaltrials.gov) - P1 | N=48 | Completed | Sponsor: Biora Therapeutics, Inc. | Recruiting ➔ Completed

Trial completion

Third Quarter 2024 and Recent Highlights (GlobeNewswire) - "Presented Phase 1 Clinical Trial Data at ACG 2024. Biora presented a summary of the Phase 1 clinical trial results for BT-600 at the American College of Gastroenterology Annual Meeting, receiving a Presidential Poster Award from ACG for high quality, novel research."

P1 data • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis

Single Ascending Dose Results From a Phase 1 Clinical Trial of BT-600, a Combination Product of the NaviCap Targeted Oral Delivery Platform and Tofacitinib (ACG 2024) - "Adverse events were mild, transient, and consistent with those expected in a healthy population. All 24 participants demonstrated systemic absorption following a single dose, with PK parameters consistent with colonic delivery, in distinction to delivery in the upper GI tract. Tofacitinib was first detected in plasma at ~6 hours following administration of BT-600."

Clinical • P1 data • Gastroenterology • Gastrointestinal Disorder • Inflammatory Bowel Disease • Ulcerative Colitis

Biora Therapeutics Announces Funding Agreement with Existing Investors (GlobeNewswire) - "Biora Therapeutics, Inc...announced the signing of financing agreements with its existing convertible notes holders....'Active pharma collaborator interest in our BioJet platform, and recent promising clinical trial results from our NaviCap platform, are drivers for this commitment.'"

Financing • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Biora Therapeutics Provides Corporate Update and Reports Second Quarter 2024 Financial Results (GlobeNewswire) - "Biora will present Phase 1 clinical trial data from the BT-600 program at the American College of Gastroenterology annual meeting in October, 2024. Initiation of a Phase 1B clinical study in active ulcerative colitis patients is anticipated toward the end of 2024."

New P1 trial • P1 data • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Biora Therapeutics Announces Supplemental Data from Phase 1 Clinical Trial of BT-600 as Presented at KOL Event (GlobeNewswire) - "Biora Therapeutics, Inc...presented supplemental data from the Phase 1 trial of BT-600 during the company’s virtual KOL event on Wednesday, July 17, 2024. BT-600, an orally administered drug-device combination, is in development for the treatment of patients with ulcerative colitis (UC). BT-600 leverages Biora’s ingestible NaviCap device to deliver a proprietary liquid formulation of tofacitinib directly to the colon."

P1 data • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Biora Therapeutics to Host Virtual KOL Event on NaviCap Targeted Oral Delivery Platform and Results from Phase 1 Clinical Trial of BT-600 on July 17, 2024 (GlobeNewswire) - "Biora Therapeutics, Inc...announced further details on its virtual event to be held on Wednesday, July 17, 2024. The event will feature Bruce Sands, MD, MS (Icahn School of Medicine at Mount Sinai) and Brian Feagan, MD, FRCPC (Schulich School of Medicine & Dentistry at the University of Western Ontario), who will discuss the unmet need and current treatment landscape for patients with ulcerative colitis (UC), as well as the value of colonic drug delivery for improving efficacy. Biora leadership will highlight key results from the Phase 1 clinical trial of BT-600, an orally administered drug-device combination in development for the treatment of patients with ulcerative colitis (UC)."

P1 data • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Biora Therapeutics Announces Positive Clinical Trial Results for BT-600 (GlobeNewswire) - P1 | N=48 | NCT06275464 | Sponsor: Biora Therapeutics, Inc. | "Biora Therapeutics, Inc...shared positive topline results from its clinical trial of BT-600, an orally administered drug-device combination in development for the potential treatment of patients with ulcerative colitis (UC)....Results from this Phase 1 clinical trial involving 48 healthy volunteers met all trial objectives, with demonstrated drug absorption in colonic tissue that extended to the distal colon, suggesting pan-colonic delivery. Daily dosing with BT-600 was well tolerated by all participants....Results from the Phase 1 clinical trial demonstrate a pharmacokinetic (PK) profile consistent with drug delivery and absorption in the colon for both single and multiple ascending dose (SAD/MAD) cohorts."

P1 data • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Biora Therapeutics Presents Clinical Data on Device Function of the NaviCap Platform at Digestive Disease Week 2024 (GlobeNewswire) - P=NA | N=NA | "Biora Therapeutics, Inc...presented a poster...at the Digestive Disease Week conference in Washington DC, on Sunday, May 19, 2024. 'In four separate clinical studies, we evaluated the functionality and safety of the NaviCap device in healthy participants and in patients with active ulcerative colitis (UC),'...'The NaviCap device was well-tolerated in 81 administrations to 47 participants, releasing its payload in the colon, regardless of variable GI transit time, the level of inflammation, or the presence of blood in stool. The NaviCap platform’s ability to function across variable GI conditions and eating schedules illustrates its potential to deliver therapeutics locally to the colon of patients with UC.'"

Clinical data • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Biora Therapeutics Provides Corporate Update and Reports First Quarter 2024 Financial Results (GlobeNewswire) - "NaviCap Targeted Oral Delivery Platform and BT-600 in ulcerative colitis: Biora expects to receive final SAD/MAD data during Q2 2024 and plans to present topline data from the clinical trial toward the end of the second quarter. The company will present clinical data on the function of the NaviCap device across four different studies in healthy human participants and active UC patients at the Digestive Disease Week (DDW) conference on May 19, 2024."

P1 data • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Biora Therapeutics Announces Completion of Multiple-Ascending Dose (MAD) Cohorts for Clinical Trial of BT-600 (GlobeNewswire) - "Biora Therapeutics, Inc...announced completion of dosing for the multiple-ascending dose cohorts for its clinical study of BT-600, a drug-device combination consisting of the orally administered NaviCap device that delivers a proprietary liquid formulation of tofacitinib to the colon. BT-600 is being developed for the potential treatment of patients with ulcerative colitis (UC). The MAD portion of the trial evaluated daily doses of BT-600 for seven days at 5 mg and 10 mg tofacitinib or placebo, in healthy adult participants....'We expect to receive data from the study, including all SAD and MAD cohorts, this quarter.'"

P1 data • Trial status • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Biora Therapeutics Achieves Positive Interim Results for Clinical Trial of BT-600, Advancing NaviCap Platform Development (GlobeNewswire) - P1 | N=48 | NCT06275464 | Sponsor: Biora Therapeutics, Inc. | "Biora Therapeutics, Inc...shared additional positive interim results from the single-ascending dose (SAD) clinical trial of BT-600, which is a drug-device combination consisting of the orally administered NaviCap device that delivers a proprietary liquid formulation of tofacitinib to the colon...According to the interim clinical data, all pharmacokinetic endpoints were met in all study participants. BT-600 was well tolerated with no serious adverse events. All devices performed as intended, with all participants receiving BT-600 showing systemic drug absorption...The mean time to reach maximum concentration (T_max) was 8–10 hours following administration of BT-600....The multiple-ascending dose (MAD) portion of the trial, currently underway, will evaluate daily doses of BT-600 for 7 days at 5 mg and 10 mg tofacitinib or placebo. Final results are expected to be available in late Q2 2024."

P1 data • PK/PD data • Trial status • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis

Biora Therapeutics Provides Corporate Update and Reports Fourth Quarter and Full-Year 2023 Financial Results (GlobeNewswire) - Anticipated Milestones: Conclusion of the Phase 1 clinical trial of BT-600 is anticipated. The company expects to receive final SAD/MAD data, including colon tissue biopsy results, during Q2 2024 and plans to present topline data from the trial shortly afterward. A clinical study in active ulcerative colitis patients is planned during the second half of 2024."

New trial • P1 data • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Biora Therapeutics Announces Successful Completion of Single-Ascending Dose (SAD) Cohorts of Phase 1 Clinical Study of BT-600 (GlobeNewswire) - "With SAD cohorts complete, MAD cohorts to begin dosing in March...Biora Therapeutics, Inc...announced completion of the single-ascending dose (SAD) cohorts for its phase 1, first-in-human clinical study of BT-600 in healthy adult volunteers....'We anticipate sharing data from the SAD portion of the study during our corporate update in March, and we plan to have final study data, which includes all SAD and MAD cohorts, in the second quarter...'"

P1 data • Trial status • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

BT-600 Single and Multiple Ascending Oral Doses in Healthy Adult Subjects (clinicaltrials.gov) - P1 | N=48 | Recruiting | Sponsor: Biora Therapeutics, Inc.

New P1 trial

Biora Therapeutics Provides Outlook for 2024 (GlobeNewswire) - "2024 Anticipated Milestones...Phase 1 SAD/MAD study data for BT-600 in healthy volunteers. Initial data from the SAD arm expected in 2-3 months, followed by MAD results including tissue data. Potential phase 1B study in UC patients. Developing study protocol with a goal to generate data for BT-600 in ulcerative colitis patients ahead of future phase 2 study. 56-day GLP tox study with BT-600. Planned to begin in 2H 2024; enabling requirement for larger and longer duration clinical studies."

P1 data • Preclinical • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Biora Therapeutics Announces Initiation of Phase 1 Clinical Study of BT-600 (GlobeNewswire) - "Biora Therapeutics, Inc...announced initiation of its phase 1, first-in-human clinical study of BT-600 in healthy adult volunteers. BT-600 is a drug-device combination program consisting of the orally administered NaviCap device which delivers a unique, liquid formulation of tofacitinib to the colon for the potential treatment of moderate to severe ulcerative colitis."

Trial status • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Biora Therapeutics Announces FDA Clearance of IND Application for Drug/Device Combination BT-600 Targeting Treatment of Ulcerative Colitis (GlobeNewswire) - "Biora Therapeutics...announced that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application for BT-600, a drug/device combination for the treatment of moderate to severe ulcerative colitis....'We look forward to completing the activities required by FDA and the trial site prior to enrolling the first subject in our phase 1 clinical trial in the United States in the coming weeks'....The phase 1 trial of BT-600 is planned as a randomized, double-blind, placebo-controlled, single and multiple ascending dose study to evaluate safety, pharmacokinetics and pharmacodynamics, including effects on colon tissue, in healthy volunteers receiving BT-600 with tofacitinib at 5 mg and 10 mg doses."

IND • New P1 trial • Ulcerative Colitis

Biora Therapeutics Provides Corporate Update and Reports Third Quarter 2023 Financial Results (Streetinsider.com) - "NaviCa Targeted Oral Delivery Platform and BT-600 in ulcerative colitis: FDA response to IND application for BT-600 is anticipated, with Phase 1 trial initiation expected before the end of 2023, followed by execution in Q1 2024, and final data assessment in Q2 2024."

New P1 trial • P1 data • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Biora Therapeutics to Submit Updated IND Application for BT-600 (BioSpace) - "Biora Therapeutics, Inc...announced an update regarding its Investigational New Drug (IND) application. The IND application supports the next phase of development of BT-600, a drug/device combination designed to use Biora’s NaviCap ingestible drug delivery device with a proprietary liquid formulation of tofacitinib, for the treatment of moderate to severe ulcerative colitis....The phase 1 trial of BT-600 is expected to be a randomized, double-blind, placebo-controlled study to evaluate safety, pharmacokinetics and pharmacodynamics, including effects on colon tissue, in healthy volunteers receiving the NaviCap device filled with a novel liquid formulation of tofacitinib at 5 mg and 10 mg doses."

IND • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Biora Therapeutics Submits Updated IND Application for BT-600 (GlobeNewswire) - "Biora Therapeutics, Inc...today announced that it submitted an updated Investigational New Drug (IND) application for BT-600 to the U.S. Food and Drug Administration (FDA) as planned. The update includes additional clarifying information and provides additional time for regulatory review of the company’s IND filing....The IND application for BT-600 includes extensive manufacturing, preclinical, human device function, and toxicology data to support a first-in-human clinical trial for BT-600, a drug/device combination designed to use Biora’s NaviCap™ ingestible drug delivery device with a proprietary liquid formulation of tofacitinib for the treatment of moderate to severe ulcerative colitis."

IND • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Biora Therapeutics Announces Submission of IND Application to the U.S. FDA for BT-600 Program (GlobeNewswire) - "Biora Therapeutics, Inc...today announced submission of an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA). The IND application supports the next phase of development of BT-600, a drug/device combination designed to use Biora’s NaviCap™ ingestible drug delivery device with a proprietary liquid formulation of tofacitinib, for the treatment of moderate to severe ulcerative colitis....The IND application for BT-600 includes extensive manufacturing, preclinical, human device function, and toxicology data to support a first-in-human clinical trial for BT-600....The phase 1 trial of BT-600 is expected to be a randomized, double-blind, placebo-controlled study to evaluate safety, pharmacokinetics and pharmacodynamics, including effects on colon tissue, in healthy volunteers..."

IND • New P1 trial • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Biora Therapeutics Provides Corporate Update and Reports Second Quarter 2023 Financial Results (GlobeNewswire) - "Second Quarter 2023 and Other Recent Corporate Highlights...The company remains on track for a September 2023 IND filing for the BT-600 program."

IND • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Biora Therapeutics to Participate in Crohn’s & Colitis Foundation’s IBD Innovate Conference (GlobeNewswire) - "Biora Therapeutics, Inc...announced that it will participate in IBD Innovate: Product Development for Crohn’s & Colitis, an event hosted by the Crohn’s & Colitis Foundation to showcase innovative product development programs in inflammatory bowel disease (IBD), which will take place in New York City on April 26, 2023. Biora’s Head of Strategy and Business Development, Chris Wahl, MD, MBA, will present a session titled 'Colonic Delivery of Therapies by a Novel Ingestible Medical Device.' The presentation will focus on Biora’s NaviCap™ targeted oral delivery platform currently under development, which is designed to improve patient outcomes in ulcerative colitis by increasing the available dose at the site of disease while reducing systemic toxicity."

Clinical • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Biora Therapeutics Presents Data from Device Performance Study with Repeat Doses in Both Fasted and Fed States at Crohn’s & Colitis Congress (GlobeNewswire) - P=NA | N=12 | "Biora Therapeutics, Inc...today presented detailed results from its PM-611 study...during the Crohn’s & Colitis Congress in Denver, CO, being held January 19-21, 2023....A total of 46 devices were ingested by 12 participants. All devices were safely ingested and exited the body naturally, with no serious adverse events reported. No investigational drug was administered during the study....Biora remains on track for an IND filing during the first half of 2023, followed by clinical trial initiation."

Clinical data • IND • New trial • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis