CELIAC DISEASE


Associated tags: Coeliac disease, Disease, CED, Patient, Incidence, HLA, Research, Clinical trial, Health, Pharmaceutical industry, Biotechnology, Short course immune induction therapy, Conference, Vaccine, Therapy, ET, Webcast, Safety, Diarrhea, Nausea, Abdominal pain, Medical imaging, Inflammation

First Wave BioPharma Announces Two Abstracts on Celiac Disease Research Accepted for Presentation at the 2024 Digestive Disease Week (DDW) Conference

Retrieved on: 
Monday, March 18, 2024

BOCA RATON, Fla., March 18, 2024 (GLOBE NEWSWIRE) -- First Wave BioPharma, Inc., (NASDAQ: FWBI), (“First Wave BioPharma” or the “Company”), a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, today announced that two abstracts have been accepted for presentation at the 2024 Digestive Disease Week Conference (DDW 2024) taking place May 18-21, 2024, in Washington, D.C.

Key Points: 
  • “The abstracts accepted for presentation at DDW 2024 showcase significant advancements in the field of gastroenterology, particularly in the precision diagnosis and management of celiac disease through the innovative VCIEL scale that our team has developed,” stated James Sapirstein, Chairman and CEO of First Wave BioPharma.
  • Details on the presentations are as follows:
    Jack Syage, PhD.
  • President & Chief Operating Officer, First Wave BioPharma
    Jack Syage, PhD.
  • President & Chief Operating Officer, First Wave BioPharma

First Wave BioPharma Announces Completion of Business Combination with ImmunogenX, Adding Phase 3-Ready Latiglutenase to its Late-Stage GI-Focused Clinical Pipeline

Retrieved on: 
Thursday, March 14, 2024

BOCA RATON, Fla., March 14, 2024 (GLOBE NEWSWIRE) -- First Wave BioPharma, Inc., (NASDAQ: FWBI), (“First Wave BioPharma” or the “Company”), a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, today announced it has acquired ImmunogenX in an all-stock transaction with the combined company focused on advancing a GI pipeline comprised of multiple, late-stage clinical assets, including latiglutenase, a potentially first-in-class, near Phase 3-ready, targeted, oral biotherapeutic for celiac disease. James Sapirstein will continue to serve as Chairman and Chief Executive Officer of First Wave BioPharma with Jack Syage, Ph.D., previously the Chief Executive Officer and Co-Founder of ImmunogenX, assuming the role of President and Chief Operating Officer of First Wave BioPharma. Dr. Syage and Dr. Chaitan Khosla will also join the board of directors of First Wave BioPharma.

Key Points: 
  • Dr. Syage and Dr. Chaitan Khosla will also join the board of directors of First Wave BioPharma.
  • First Wave BioPharma intends to license the commercial rights to latiglutenase in the United States and Canada to a strategic global pharmaceutical company which will commercialize latiglutenase following receipt of marketing approval.
  • First Wave BioPharma will also seek to secure financing commitments from a syndicate of institutional healthcare investors to fund the ongoing development of latiglutenase.
  • First Wave BioPharma will host a conference call and live audio webcast today, March 14, 2024, at 8:30 a.m.

Topas Therapeutics Initiates Phase 2a Clinical Trial for TPM502 in Celiac Disease; Appoints Chief Business Officer and Chief Operating Officer

Retrieved on: 
Thursday, May 25, 2023

The company has received approval to initiate TPM502’s clinical development in a Phase 2a study based on TPM502 preclinical data and clinical results from the Phase 1 study assessing Topas’ TPC TPM203 in patients with pemphigus vulgaris.

Key Points: 
  • The company has received approval to initiate TPM502’s clinical development in a Phase 2a study based on TPM502 preclinical data and clinical results from the Phase 1 study assessing Topas’ TPC TPM203 in patients with pemphigus vulgaris.
  • “The Phase 2a study will determine the capacity of TPM502 to promote immune tolerization in celiac disease patients and will confirm the safety profile of TPCs.
  • It will also further establish the potential of the Topas platform to generate novel therapeutics for the treatment of T-cell-mediated diseases,” commented Cristina de Min, MD, Chief Medical Officer of Topas Therapeutics.
  • Mireia Gómez-Angelats, PhD, has joined as Chief Business Officer and Christian Schröter, PhD, as Chief Operating Officer, adding significant international pharmaceutical experience to Topas’ leadership as the company moves to mid-stage clinical development.

EQS-News: Immunic Reports Positive Results From Phase 1b Clinical Trial of IMU-856 in Celiac Disease, Providing Clinical Proof-of-Concept for New Therapeutic Approach to Gastrointestinal Disorders

Retrieved on: 
Thursday, May 4, 2023

Immunic Reports Positive Results From Phase 1b Clinical Trial of IMU-856 in Celiac Disease, Providing Clinical Proof-of-Concept for New Therapeutic Approach to Gastrointestinal Disorders

Key Points: 
  • Immunic Reports Positive Results From Phase 1b Clinical Trial of IMU-856 in Celiac Disease, Providing Clinical Proof-of-Concept for New Therapeutic Approach to Gastrointestinal Disorders
    The issuer is solely responsible for the content of this announcement.
  • The company believes that this data set provides initial clinical proof-of-concept for an entirely new therapeutic approach to gastrointestinal disorders by promoting regeneration of bowel architecture.
  • Decrease in villous height is a well-recognized measure of gluten-induced damage in celiac disease and a main reason for signs and symptoms of malabsorption.
  • Immunic will host a webcast today, May 4, 2023, at 8:00 am ET to discuss these results.

Immunic Reports Positive Results From Phase 1b Clinical Trial of IMU-856 in Celiac Disease, Providing Clinical Proof-of-Concept for New Therapeutic Approach to Gastrointestinal Disorders

Retrieved on: 
Thursday, May 4, 2023

NEW YORK, May 4, 2023 /PRNewswire/ -- Immunic, Inc. (Nasdaq: IMUX), a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases, today announced positive results from the part C portion of its phase 1 clinical trial of IMU-856 in patients with celiac disease. The company believes that this data set provides initial clinical proof-of-concept for an entirely new therapeutic approach to gastrointestinal disorders by promoting regeneration of bowel architecture.

Key Points: 
  • The company believes that this data set provides initial clinical proof-of-concept for an entirely new therapeutic approach to gastrointestinal disorders by promoting regeneration of bowel architecture.
  • Decrease in villous height is a well-recognized measure of gluten-induced damage in celiac disease and a main reason for signs and symptoms of malabsorption.
  • Immunic will host a webcast today, May 4, 2023, at 8:00 am ET to discuss these results.
  • Registrants will receive a confirmation email containing a link for online participation or a telephone number for dial in access.

Immunic to Host Virtual Celiac Disease R&D Day to Highlight Current Pathways for Drug Development and Unmet Medical Need

Retrieved on: 
Thursday, February 9, 2023

NEW YORK, Feb. 9, 2023 /PRNewswire/ -- Immunic, Inc. (Nasdaq: IMUX), a clinical-stage biopharmaceutical company developing a pipeline of selective oral immunology therapies focused on treating chronic inflammatory and autoimmune diseases, announced that its Celiac Disease R&D Webcast will take place today, February 9, 2023 from 11:00 am to 1:00 pm ET.

Key Points: 
  • He will focus on the relevance of the pro-inflammatory cytokine interleukin-2 (IL-2) as objective biomarker that correlates with onset and severity of symptoms after gluten exposure and its relevance for clinical celiac disease trials.
  • "We look forward to hosting this deep-dive discussion, focused on the current challenges of treating celiac disease with two, such renowned thought leaders as Drs.
  • The Celiac Disease R&D Day webcast will be held virtually via Zoom.
  • An archived replay of the webcast will be available approximately one hour after completion on Immunic's website at: ir.imux.com/events-and-presentations .

EQS-News: Immunic to Host Virtual Celiac Disease R&D Day to Highlight Current Pathways for Drug Development and Unmet Medical Need

Retrieved on: 
Monday, February 13, 2023

“We look forward to hosting this deep-dive discussion, focused on the current challenges of treating celiac disease with two, such renowned thought leaders as Drs.

Key Points: 
  • “We look forward to hosting this deep-dive discussion, focused on the current challenges of treating celiac disease with two, such renowned thought leaders as Drs.
  • Murray and Schumann,” stated Daniel Vitt, Ph.D., Chief Executive Officer and President of Immunic.
  • Registrants will receive a confirmation email containing a link for online participation or a telephone number for dial in access.
  • An archived replay of the webcast will be available approximately one hour after completion on Immunic’s website at: ir.imux.com/events-and-presentations .

Equillium Announces Initiation of Phase 1 study of EQ102, A First-in-Class Multi-Cytokine Inhibitor of IL-15 and IL-21 Targeting Celiac Disease

Retrieved on: 
Wednesday, November 2, 2022

Following the SAD/MAD portion of this study Equillium plans to evaluate the biological activity of EQ102 in subjects with celiac disease.

Key Points: 
  • Following the SAD/MAD portion of this study Equillium plans to evaluate the biological activity of EQ102 in subjects with celiac disease.
  • We believe this may be an optimal approach to treating patients with celiac disease, and we look forward to reporting initial clinical data from this study next year.
  • Following the MAD portion of this study, Part C of the study will evaluate the biological activity of EQ102 in subjects with celiac disease.
  • Equillium is currently enrolling patients in a Phase 1 study of EQ102, including healthy volunteers and celiac disease patients.

DGAP-News: Immunic Announces Start of Patient Cohorts in Its Phase 1 Clinical Trial of IMU-856 in Celiac Disease

Retrieved on: 
Thursday, May 5, 2022

Because it represents a significant unmet need with well characterized surrogate markers of disease activity, we believe that celiac disease is an ideal initial clinical indication to provide proof-of-concept of IMU-856s acute and chronic impact.

Key Points: 
  • Because it represents a significant unmet need with well characterized surrogate markers of disease activity, we believe that celiac disease is an ideal initial clinical indication to provide proof-of-concept of IMU-856s acute and chronic impact.
  • Celiac disease is a life-long and serious autoimmune disease of the small bowel whose pathophysiology is due to gluten-induced damage to the intestinal barrier.
  • Parts A and B of the ongoing phase 1 clinical trial are evaluating single and multiple ascending doses of IMU-856 in healthy human subjects.
  • In November 2018, Immunic and Daiichi Sankyo entered into a global option and license agreement, granting Immunic the exclusive right to license IMU-856.

SQZ Biotechnologies Publishes Comprehensive Preclinical Research on SQZ® TAC Platform’s Ability to Induce Multiple Key Mechanisms of Antigen-Specific Tolerance and Protect Against Type 1 Diabetes

Retrieved on: 
Monday, April 4, 2022

SQZ Biotechnologies (NYSE: SQZ), focused on unlocking the full potential of cell therapies for multiple therapeutic areas, today announced the publication of comprehensive preclinical research on the SQZ Tolerizing Antigen Carrier (TAC) platform.

Key Points: 
  • SQZ Biotechnologies (NYSE: SQZ), focused on unlocking the full potential of cell therapies for multiple therapeutic areas, today announced the publication of comprehensive preclinical research on the SQZ Tolerizing Antigen Carrier (TAC) platform.
  • In an in vivo model of type 1 diabetes (T1D), the TAC treatment was able to combat active autoimmune responses and prevent hyperglycemia.
  • We are excited to publish this comprehensive data set that demonstrates how in preclinical models SQZ TACs can induce multiple mechanisms of antigen-specific tolerance with long-lasting effects, said Howard Bernstein, M.D., Ph.D., Chief Scientific Officer at SQZ Biotechnologies.
  • Taken together, this supports our belief that SQZ TACs may enable the development of differentiated therapies for a variety of complex autoimmune diseases, including type 1 diabetes and celiac disease.