IBD

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

Retrieved on: 
Dienstag, Februar 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: 
Donnerstag, Februar 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: 
Montag, Februar 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: 
Montag, Februar 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: 
Montag, Februar 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: 
Donnerstag, Februar 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: 
Mittwoch, Februar 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: 
Dienstag, Februar 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.

Takeda Supports the Canadian IBD Research Consortium's $1 Million Pioneer Grant for Second Year

Retrieved on: 
Dienstag, Februar 13, 2024

TORONTO, Feb. 13, 2024 /CNW/ - Takeda Canada Inc. (Takeda) is pleased to announce its support of the Canadian Inflammatory Bowel Disease Research Consortium's (CIRC) $1 million PIONEER Grant in its second year.

Key Points: 
  • TORONTO, Feb. 13, 2024 /CNW/ - Takeda Canada Inc. (Takeda) is pleased to announce its support of the Canadian Inflammatory Bowel Disease Research Consortium's (CIRC) $1 million PIONEER Grant in its second year.
  • This grant, with Takeda contributing $500,000 of the $1,000,000 award, will continue to support high-quality, impactful Canadian clinical research to improve patient outcomes and quality of life for people living with inflammatory bowel disease (IBD).
  • "We are immensely proud of our research community, this program and are grateful for Takeda partnership and dedication to advancing research in Canada."
  • "The PIONEER Grant, established through $1,000,000 in support from Takeda, gives Canadian IBD researchers an amazing and truly unique opportunity to conduct practice changing investigator-initiated research.

Palisade Bio Provides Corporate Update and Reiterates Guidance

Retrieved on: 
Dienstag, Februar 13, 2024

Carlsbad, CA, Feb. 13, 2024 (GLOBE NEWSWIRE) -- Palisade Bio, Inc. (Nasdaq: PALI) (“Palisade” or the “Company”), a biopharmaceutical company focused on developing novel therapeutics for serious chronic gastrointestinal (GI) diseases, today provided a corporate update and reiterated upcoming milestones.

Key Points: 
  • “We continue to make significant development progress with PALI-2108, our lead program.
  • The program is providing us with a growing body of data that we find encouraging, including support for a precision medicine approach,” commented J.D.
  • Although smaller, we believe the reconstituted board better matches our stage of development while retaining ethnic and gender diversity.
  • PALI-2108 is an orally administered, locally acting colon-specific phosphodiesterase-4B (PDE4B) inhibitor prodrug in development for patients affected by UC.