tranexamic acid (LB1148) / Palisade Bio - LARVOL DELTA

A Study to Evaluate LB1148 for Return of Gastrointestinal Function and Adhesions in Subjects Undergoing Bowel Resection (clinicaltrials.gov) - P2 | N=112 | Completed | Sponsor: Palisade Bio | Recruiting ➔ Completed | N=200 ➔ 112 | Trial primary completion date: Jun 2023 ➔ Sep 2023

Enrollment change • Trial completion • Trial primary completion date • Gastrointestinal Disorder

INTEGRITY: A Study to Evaluate LB1148 for Return of Bowel Function in Subjects Undergoing Bowel Resection (clinicaltrials.gov) - P3 | N=23 | Terminated | Sponsor: Palisade Bio | N=600 ➔ 23 | Trial completion date: Sep 2024 ➔ Aug 2023 | Active, not recruiting ➔ Terminated; Company decision

Enrollment change • Trial completion date • Trial termination • Gastroenterology • Gastrointestinal Disorder

Margaret Ragni, MD, MPH: Tranexamic Acid in VWD-Related Heavy Menstrual Bleeding (YouTube) - "Dr. Aaron Gerds interviews...to discuss her abstract on tranexamic acid compared to recombinant von Willebrand factor for the reduction of heavy menstrual bleeding among women with von Willebrand disease, the results of which were presented at the 64th ASH Annual Meeting and Exposition in New Orleans, Louisiana."

Interview • Video

"$PALI Palisade Bio Releases In-Depth Explanation of Scientific Approach of Lead Product Candidate LB1148 Through Animated Video https://t.co/bMk8xNuyGx" (@stock_titan)

Video

INTEGRITY: A Study to Evaluate LB1148 for Return of Bowel Function in Subjects Undergoing Bowel Resection (clinicaltrials.gov) - P3 | N=600 | Active, not recruiting | Sponsor: Palisade Bio | Recruiting ➔ Active, not recruiting

Enrollment closed • Gastroenterology • Gastrointestinal Disorder

LB1148 An Enteral Protease Inhibitor Significantly Accelerated the Return of Bowel Function after Bowel Resection (ACS-CLINCON 2022) - "The aim of this study was to determine if a novel enteral formulation of tranexamic acid, LB1148, could accelerate return of GI function in patients undergoing bowel resection surgery. We conducted a phase 2 multicenter, randomized, double-blind, placebo-controlled study of LB1148 for the restoration of post-operative bowel function in patients undergoing elective bowel resection. For patients undergoing elective bowel resection surgery, LB1148 was safe and well-tolerated and significantly accelerated the return of bowel function."

Gastrointestinal Disorder

"$PALI Palisade Bio Streamlines Operations and Identifies Capital Efficiencies to Focus All Resources on Advancement of Lead Clinical Program, LB1148 https://t.co/igQyrhrwZP" (@stock_titan)

Clinical

INTEGRITY: A Study to Evaluate LB1148 for Return of Bowel Function in Subjects Undergoing Bowel Resection (clinicaltrials.gov) - P3 | N=600 | Recruiting | Sponsor: Palisade Bio

New P3 trial • Gastroenterology • Gastrointestinal Disorder

Palisade Bio (BIO 2022) - "Plans are underway to commence a pivotal, Phase 3 study of LB1148 in the second half of 2022. Palisade Bio believes that its investigational therapies have the potential to address the myriad health conditions and complications associated with the chronic disruption to the gastrointestinal epithelial barrier."

Gastrointestinal Disorder

Leading BioSciences announces top line P2 data demonstrating LB1148 achieves primary endpoint (GlobeNewswire) - P2, N=120; PROFILE (NCT02836470); Sponsor: Leading BioSciences, Inc; “Leading BioSciences…today announced top line Phase 2 data demonstrating its lead compound, LB1148, provided a 30% improvement in the time to normal bowel function following cardiovascular surgery (p<0.001) compared to placebo. This improvement resulted in a 1.1-day reduction in average length of stay in the ICU and a 1.2-day reduction in average hospital length of stay. One of the primary factors in discharging patients from the hospital following surgery is the return of bowel function….LB1148 was also shown to be safe and well-tolerated in the study.”

P2 data

LB1148 for Pulmonary Dysfunction Associated With COVID-19 Pneumonia (clinicaltrials.gov) - P2 | N=0 | Withdrawn | Sponsor: Leading BioSciences, Inc | N=120 ➔ 0 | Not yet recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal • Infectious Disease • Novel Coronavirus Disease • Pneumonia • Pulmonary Disease • Respiratory Diseases

A Study to Evaluate LB1148 for Return of Gastrointestinal Function and Adhesions in Subjects Undergoing Bowel Resection (clinicaltrials.gov) - P2 | N=200 | Recruiting | Sponsor: Palisade Bio | Trial primary completion date: Dec 2021 ➔ Jun 2023 | N=120 ➔ 200 | Trial completion date: Mar 2022 ➔ Dec 2023

Enrollment change • Trial completion date • Trial primary completion date • Gastrointestinal Disorder

"$PALI Palisade Bio (Nasdaq: PALI) Announces Analysis Demonstrating LB1148 Reduced the Extent and Severity of Post-Surgical Intraabdominal Adhesions by 93% https://t.co/FWoGWkxnf9" (@stock_titan)

Study to Evaluate LB1148 for Return of Gastrointestinal Function, Decrease Post-Operative Ileus (clinicaltrials.gov) - P2; N=131; Completed; Sponsor: Newsoara Biopharma Co., Ltd.

Clinical • New P2 trial • Gastrointestinal Disorder

Seattle Cancer Care Alliance to Present New Research at 62nd Annual Meeting of the American Society of Hematology (Businesswire) - "Seattle Cancer Care Alliance...announced that its clinicians will present new research at the 62nd Annual Meeting of the American Society of Hematology, which is being held virtually December 5-8, 2020...This includes outcomes and utilization of various therapies in multiple myeloma, results from immunotherapy clinical trials and perspectives from patient-reported outcomes in CAR-T cell therapy. Other findings being presented are related to treating refractory follicular lymphoma, liso-cel vs. axi-cel in large B-cell lymphoma (LBCL), and personalized cancer care across hematology....Incidence of and Risk Factors for Venous Thromboembolism Among Hospitalized Patients with Cancer and COVID-19: Report from the COVID-19 and Cancer Consortium (CCC19) Registry...Nicole Kuderer, MD."

P1 data • P1/2 data • P2 data • Preclinical • Retrospective data • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Chronic Myeloid Leukemia • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology

"$PALI Palisade Bio Hosting Key Opinion Leader Webinar on LB1148, an Oral Serine Protease Inhibitor for Postoperative GI Dysfunction https://t.co/51NshMCXp7" (@stock_titan)

Gastrointestinal Disorder

A Study to Evaluate LB1148 for Return of Gastrointestinal Function and Adhesions in Subjects Undergoing Bowel Resection (clinicaltrials.gov) - P2; N=120; Recruiting; Sponsor: Leading BioSciences, Inc; Trial completion date: Mar 2021 ➔ Mar 2022; Trial primary completion date: Sep 2020 ➔ Dec 2021

Clinical • Trial completion date • Trial primary completion date • Gastrointestinal Disorder

LB1148 for Pulmonary Dysfunction Associated With COVID-19 Pneumonia (clinicaltrials.gov) - P2; N=120; Not yet recruiting; Sponsor: Leading BioSciences, Inc; Trial completion date: Mar 2021 ➔ Mar 2022; Initiation date: Oct 2020 ➔ Oct 2021; Trial primary completion date: Dec 2020 ➔ Dec 2021

Trial completion date • Trial initiation date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases • PCR

A Study to Evaluate the Safety, Tolerability and Efficacy of LB1148 for Subjects Undergoing Elective Bowel Resection (clinicaltrials.gov) - P1; N=11; Completed; Sponsor: Ronald Hurst, MD, FACS; Active, not recruiting ➔ Completed; Trial completion date: Jul 2021 ➔ Dec 2020; Trial primary completion date: Nov 2020 ➔ Mar 2020

Clinical • Trial completion • Trial completion date • Trial primary completion date

LB1148 for Pulmonary Dysfunction Associated With COVID-19 Pneumonia (clinicaltrials.gov) - P2; N=120; Not yet recruiting; Sponsor: Leading BioSciences, Inc; Initiation date: Jun 2020 ➔ Oct 2020

Trial initiation date • Infectious Disease • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases

Leading BioSciences teams with Donnelley Financial Solutions to create innovative study tool for clinical trial monitoring during COVID-19 pandemic (Businesswire) - "Donnelley Financial Solutions (NYSE: DFIN)...today announced that Leading BioSciences, Inc. (LBS)...is working with DFIN to manage remote monitoring of their COVID-19 study....Use of virtual data rooms allows LBS to continue trial operations and oversight in the absence of in-person visits to hospitals and clinical sites....By allowing remote monitoring and source document verification of clinical study data, LBS has been able to continue its development activities..."

Licensing / partnership • Infectious Disease • Novel Coronavirus Disease

LB1148 for Pulmonary Dysfunction Associated With COVID-19 Pneumonia (clinicaltrials.gov) - P2; N=120; Not yet recruiting; Sponsor: Leading BioSciences, Inc

New P2 trial • Infectious Disease • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases

A Study to Evaluate the Safety, Tolerability and Efficacy of LB1148 for Subjects Undergoing Elective Bowel Resection (clinicaltrials.gov) - P1; N=11; Active, not recruiting; Sponsor: Ronald Hurst, MD, FACS; Recruiting ➔ Active, not recruiting; N=20 ➔ 11

Clinical • Enrollment change • Enrollment closed

Leading BioSciences Receives IND Clearance for Phase 2 COVID-19 Study (GlobeNewswire, Leading BioSciences) - "Leading BioSciences, Inc (LBS)...today announced the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for a phase 2 study of its lead investigational drug, LB1148 for the 'treatment of pulmonary dysfunction associated with COVID-19 pneumonia'. The study will include 120 hospitalized adult patients with respiratory dysfunction due to COVID-19. The primary objective of this study is to determine whether oral/enteral administration of liquid LB1148 will impact disease progression....Currently the company is collaborating with multiple hospitals throughout the United States....Study protocol has been approved by a central Investigational Review Board (IRB) to proceed with patient enrollment."

DSMB • IND • New P2 trial • Infectious Disease • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases

Treatment of Septic Shock by Inhibiting Autodigestion and Preserving Gut Integrity With Enteric LB1148 (clinicaltrials.gov) - P2; N=260; Recruiting; Sponsor: Leading BioSciences, Inc; Not yet recruiting -> Recruiting

Enrollment open • Biosimilar