IBD

New Research Study for Patients With Ulcerative Colitis Now Available in Ogden, Utah

Retrieved on: 
Tuesday, February 27, 2024

Adults in the Ogden, Utah area with moderately to severely active ulcerative colitis (UC) may have the opportunity to join a research study assessing a new investigational medication.

Key Points: 
  • Adults in the Ogden, Utah area with moderately to severely active ulcerative colitis (UC) may have the opportunity to join a research study assessing a new investigational medication.
  • There is no known cure for UC, though new therapies have become available in recent years that offer patients improved treatment options.
  • The ANTHEM-UC study from Janssen Research & Development seeks to assess if an investigational pill could help those patients whose UC is not adequately managed by currently available therapies.
  • The study is now enrolling for adults age 18 or older with moderately to severely active UC, who have not responded well to currently available therapies.

Celltrion presents new two-year data for subcutaneous infliximab (CT-P13 SC) in inflammatory bowel disease (IBD) at the 19th ECCO Congress

Retrieved on: 
Friday, February 23, 2024

These data were presented as poster presentations at the 19th European Crohn’s and Colitis Organisation (ECCO) annual congress in Stockholm, Sweden.

Key Points: 
  • These data were presented as poster presentations at the 19th European Crohn’s and Colitis Organisation (ECCO) annual congress in Stockholm, Sweden.
  • The LIBERTY-CD and LIBERTY-UC studies were continued up to 102 weeks as extension phase treatments, building on the initial LIBERTY trials.
  • The two-year studies assessed the long-term efficacy and safety of CT-P13 SC in patients with Crohn's disease (CD) and ulcerative colitis (UC), respectively.
  • “The early observation of mucosal healing at Week 22 showcases the potential of subcutaneous infliximab treatment in improving patient care,” said Nam Lee, Medical Director at Celltrion.

Teva Presents New Data Supporting Safety, Tolerability and Target Engagement of Anti-TL1A (TEV-‘574) Antibody at the 2024 ECCO Annual Meeting

Retrieved on: 
Tuesday, February 20, 2024

“These results from the first-in-human trials of anti-TL1A (TEV-’574) are exciting because they show that it effectively engages with the TL1A target, supports its safety profile and is well-tolerated.

Key Points: 
  • “These results from the first-in-human trials of anti-TL1A (TEV-’574) are exciting because they show that it effectively engages with the TL1A target, supports its safety profile and is well-tolerated.
  • “We are currently investigating the efficacy and safety of anti-TL1A (TEV-’574) in IBD through the RELIEVE UCCD Phase 2 trial, which features an innovative and efficient basket study design allowing the inclusion of patients with either type of IBD (ulcerative colitis and Crohn’s disease).
  • Each company will equally share the development costs globally and net profits and losses in major markets, with other markets subject to a royalty arrangement, and Sanofi will lead the development of the Phase 3 program.
  • Teva will lead commercialization of the product in Europe, Israel and specified other countries, and Sanofi will lead commercialization in North America, Japan, other parts of Asia and the rest of the world.

LISCure Biosciences Announces FDA Clearance of IND Application to Initiate a Phase 2 Study of LB-P8 for Primary Sclerosing Cholangitis (PSC)

Retrieved on: 
Thursday, February 29, 2024

LISCure anticipates treating the first patient in the upcoming months and expects topline results for Part 1 in the first half of 2025.

Key Points: 
  • LISCure anticipates treating the first patient in the upcoming months and expects topline results for Part 1 in the first half of 2025.
  • PSC is a rare, chronic, cholestatic liver disease with very high unmet medical needs where there are no approved drugs.
  • LISCure confirmed the safety, tolerability, and key biomarkers of LB-P8 in a Phase 1 study and received Orphan Drug Designation (ODD) for the treatment of PSC from the U.S. FDA.
  • LB-P8 was presented in oral presentations at the American Association for the Study of Liver Diseases (AASLD) every year for the past two years.

TransThera initiates IND-Enabling studies for TT-02332, a novel, highly potent and CNS-penetrating NLRP3 inhibitor

Retrieved on: 
Monday, February 26, 2024

NANJING, China and GAITHURSBURG, Md., Feb. 26, 2024 /PRNewswire/ -- TransThera, a clinical-stage biopharmaceutical company dedicated to innovating differentiated drugs globally, today announced the initiation of IND-enabling studies for TT-02332, a potent, selective and highly CNS-penetrating NLRP3 inflammasome inhibitor.

Key Points: 
  • NANJING, China and GAITHURSBURG, Md., Feb. 26, 2024 /PRNewswire/ -- TransThera, a clinical-stage biopharmaceutical company dedicated to innovating differentiated drugs globally, today announced the initiation of IND-enabling studies for TT-02332, a potent, selective and highly CNS-penetrating NLRP3 inflammasome inhibitor.
  • Over the past three years, we have achieved breakthroughs with the NLRP3 inhibitor program."
  • "Our clinical candidate compound TT-02332 is a highly potent NLRP3 inhibitor that has shown promising efficacy in a number of disease-relevant in vivo animal models.
  • TT-02332 demonstrates an excellent safety profile in recently completed repeated-dose toxicity studies in two animal species (Dose finding toxicity studies).

Spyre Therapeutics to Participate in the 44th Annual TD Cowen Health Care Conference

Retrieved on: 
Monday, February 26, 2024

WALTHAM, Mass., Feb. 26, 2024 /PRNewswire/ -- Spyre Therapeutics, Inc. (NASDAQ: SYRE) (the "Company" or "Spyre"), a development-stage biotechnology company advancing best-in-class antibody engineering, rational therapeutic combinations, and precision medicine approaches for the treatment of Inflammatory Bowel Disease ("IBD"), today announced that management will participate in the TD Cowen 44th Annual Health Care Conference.

Key Points: 
  • WALTHAM, Mass., Feb. 26, 2024 /PRNewswire/ -- Spyre Therapeutics, Inc. (NASDAQ: SYRE) (the "Company" or "Spyre"), a development-stage biotechnology company advancing best-in-class antibody engineering, rational therapeutic combinations, and precision medicine approaches for the treatment of Inflammatory Bowel Disease ("IBD"), today announced that management will participate in the TD Cowen 44th Annual Health Care Conference.
  • Cameron Turtle, Chief Executive Officer, will participate in the Inflammation & Immunology Corporate Panel Discussion on Tuesday, March 5, 2024, at 2:10 p.m. Eastern time.
  • To access this webcast, please visit the "Events & Presentations" page within the Investors section of the Spyre website at ir.spyre.com.
  • An archive of the webcast will be available for replay for 30 days following the end of the conference.

AbbVie Unveils New Data from Robust Gastroenterology Portfolio at the 19th Congress of European Crohn's and Colitis Organisation (ECCO)

Retrieved on: 
Monday, February 19, 2024

NORTH CHICAGO, Ill., Feb. 19, 2024 /PRNewswire/ -- AbbVie (NYSE: ABBV) announced that 17 AbbVie-sponsored abstracts, including new data from its inflammatory bowel disease (IBD) portfolio, have been accepted for presentation at the 19th Congress of European Crohn's and Colitis Organisation (ECCO) taking place in Stockholm, Sweden from February 21-24.

Key Points: 
  • The research spans risankizumab (SKYRIZI®) and upadacitinib (RINVOQ®) in both Crohn's disease (CD) and ulcerative colitis (UC).
  • "Despite continued advancements, many patients are still suffering from the debilitating effects of living with IBD," said Sofie Berg, Pharm.D, Ph.D., therapeutic area head, international immunology, International Medical Affairs, AbbVie.
  • "It is critically important that as the treatment paradigm shifts, the gastroenterology community shifts with it.
  • SKYRIZI® (risankizumab) is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization globally.

EnLiSense CCM Advances Validation of Real-Time IBD Inflammatory Biomarker Monitoring with Two Recent Peer-Reviewed Longitudinal Studies

Retrieved on: 
Thursday, February 15, 2024

Our innovative IBD Aware device offers the first solution for continuous, non-invasive monitoring of IBD through the power of sweat-sensing technology.

Key Points: 
  • Our innovative IBD Aware device offers the first solution for continuous, non-invasive monitoring of IBD through the power of sweat-sensing technology.
  • EnLiSense's journey reaches a significant milestone with over half a million human biomarker readings, underscoring the extensive validation of our technology.
  • These readings provide crucial data points, enhancing the precision and trustworthiness of inflammatory biomarker monitoring.
  • The studies involved measuring inflammation markers CRP, TNF-α, and IL-6 in subjects' blood and sweat continuously in subjects with and without IBD.

Bragar Eagel & Squire, P.C. Reminds Investors That Class Action Lawsuits Have Been Filed Against Cassava, and Amylyx and Encourages Investors to Contact the Firm

Retrieved on: 
Wednesday, February 14, 2024

Stockholders have until the deadlines below to petition the court to serve as lead plaintiff.

Key Points: 
  • Stockholders have until the deadlines below to petition the court to serve as lead plaintiff.
  • The Company's lead therapeutic drug candidate is PTI-125 (or "simufilam"), a small molecule drug for the proposed treatment of Alzheimer's disease.
  • The Complaint alleges that, throughout the Class Period, Defendants made materially false and misleading statements regarding the Company's business, operations, and prospects.
  • For more information on the Amylyx class action go to: https://bespc.com/cases/AMLX

Kirby McInerney LLP Announces the Filing of a Securities Class Action on Behalf of Amylyx Pharmaceuticals, Inc. (AMLX) Investors

Retrieved on: 
Tuesday, February 13, 2024

Investors have until April 4, 2024 to apply to the Court to be appointed as lead plaintiff in the lawsuit.

Key Points: 
  • Investors have until April 4, 2024 to apply to the Court to be appointed as lead plaintiff in the lawsuit.
  • Amylyx is a commercial-stage biotechnology company that engages in the discovery and development of treatments for Amyotrophic Lateral Sclerosis (“ALS”) and other neurodegenerative diseases.
  • Kirby McInerney LLP is a New York-based plaintiffs’ law firm concentrating in securities, antitrust, whistleblower, and consumer litigation.
  • The firm’s efforts on behalf of shareholders in securities litigation have resulted in recoveries totaling billions of dollars.