Short course immune induction therapy

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: 
Donnerstag, Mai 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: 
Donnerstag, Mai 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.

EQS-News: Immunic, Inc. Strengthens Its Board of Directors with the Appointment of Richard Rudick, M.D.

Retrieved on: 
Freitag, April 28, 2023

Immunic, Inc. Strengthens Its Board of Directors with the Appointment of Richard Rudick, M.D.

Key Points: 
  • Immunic, Inc. Strengthens Its Board of Directors with the Appointment of Richard Rudick, M.D.
  • Immunic, Inc. Strengthens Its Board of Directors with the Appointment of Richard Rudick, M.D.
  • The company also announced that Vincent Ossipow, Ph.D., will step down from the Board, effective June 28, 2023.
  • “We are very grateful to have Rick join us,” stated Duane Nash, M.D., J.D., M.B.A., Chairman of the Board of Directors of Immunic.

Immunic, Inc. Strengthens Its Board of Directors with the Appointment of Richard Rudick, M.D.

Retrieved on: 
Donnerstag, April 27, 2023

NEW YORK, April 27, 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 the appointment of Richard Rudick, M.D., a thought-leader in multiple sclerosis with decades of experience in the clinic, academia and industry, to its board of directors, effective April 26, 2023. The company also announced that Vincent Ossipow, Ph.D., will step down from the Board, effective June 28, 2023.

Key Points: 
  • The company also announced that Vincent Ossipow, Ph.D., will step down from the Board, effective June 28, 2023.
  • "We are very grateful to have Rick join us," stated Duane Nash, M.D., J.D., M.B.A., Chairman of the Board of Directors of Immunic.
  • He has published extensively and been an active participant and leader in developing the current treatment landscape for multiple sclerosis.
  • "On behalf of the entire Board of Directors, I would like to thank Vincent for his dedication to Immunic and his thoughtful guidance over the past seven years.

EQS-News: Immunic to Participate in Investor and Scientific Conferences in May

Retrieved on: 
Mittwoch, April 26, 2023

NEW YORK, April 26, 2023 – 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 participation in the following investor and scientific conferences in May:

Key Points: 
  • NEW YORK, April 26, 2023 – 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 participation in the following investor and scientific conferences in May:
    May 2-4: Aegis Virtual Conference.
  • A webcast of the presentation will be available on the “Events and Presentations” section of Immunic’s website at: https://ir.imux.com/events-and-presentations .
  • An archived replay will be available on the company’s website for a period of 90 days after the conference.
  • Hella Kohlhof, Ph.D., Chief Scientific Officer of Immunic, will present preclinical data on the antiviral properties of dihydroorotate dehydrogenase (DHODH) inhibitors in an oral presentation at this conference in Seattle, WA.

EQS-News: Immunic Reports Positive Data from Maintenance Phase of Phase 2 CALDOSE-1 Trial of Vidofludimus Calcium in Moderate-to-Severe Ulcerative Colitis

Retrieved on: 
Samstag, April 15, 2023

Immunic believes that the maintenance phase data of CALDOSE-1 confirms vidofludimus calcium's impressive activity in the absence of chronic corticosteroid co-administration.

Key Points: 
  • Immunic believes that the maintenance phase data of CALDOSE-1 confirms vidofludimus calcium's impressive activity in the absence of chronic corticosteroid co-administration.
  • Hence, the maintenance phase results are in line with the induction data without chronic concomitant use of corticosteroids and underline the performance of vidofludimus calcium in this steroid-free UC population.
  • Consistent with prior data sets in other patient populations, administration of vidofludimus calcium in the maintenance phase of this trial was observed to be safe and well-tolerated.
  • We believe this data compares favorably to available maintenance data for other UC drugs,” commented Daniel Vitt, Ph.D., Chief Executive Officer and President of Immunic.

Immunic Reports Positive Data from Maintenance Phase of Phase 2 CALDOSE-1 Trial of Vidofludimus Calcium in Moderate-to-Severe Ulcerative Colitis

Retrieved on: 
Mittwoch, April 5, 2023

NEW YORK, April 5, 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 reported positive data from the maintenance phase of its phase 2b CALDOSE-1 trial of lead asset, vidofludimus calcium (IMU-838), in patients with moderate-to-severe ulcerative colitis (UC) (clinicaltrials.gov: NCT03341962). The maintenance phase efficacy data at week 50 are as follows:

Key Points: 
  • Immunic believes that the maintenance phase data of CALDOSE-1 confirms vidofludimus calcium's impressive activity in the absence of chronic corticosteroid co-administration.
  • Hence, the maintenance phase results are in line with the induction data without chronic concomitant use of corticosteroids and underline the performance of vidofludimus calcium in this steroid-free UC population.
  • Consistent with prior data sets in other patient populations, administration of vidofludimus calcium in the maintenance phase of this trial was observed to be safe and well-tolerated.
  • The CALDOSE-1 trial of vidofludimus calcium in moderate-to-severe UC was a phase 2b, multicenter, randomized, double-blind, placebo-controlled, dose-finding study, including a blinded 10-week induction phase and a blinded 50-week maintenance phase.

Immunic Presents Data From Phase 2 EMPhASIS Trial of Vidofludimus Calcium in Relapsing-Remitting Multiple Sclerosis at ACTRIMS Forum 2023

Retrieved on: 
Mittwoch, Februar 22, 2023

NEW YORK, Feb. 22, 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, today announced that Robert J. Fox, M.D., Staff Neurologist, Mellen Center for Multiple Sclerosis, Vice-Chair for Research, Neurologic Institute, Cleveland Clinic, Cleveland, Ohio, will present data from the blinded and open-label extension (OLE) parts of the company's phase 2 EMPhASIS trial of lead asset, vidofludimus calcium (IMU-838), a selective oral DHODH inhibitor, in relapsing-remitting multiple sclerosis (RRMS) at the eighth annual Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2023, taking place February 23-25 in San Diego, California. Dr. Fox has served as Coordinating Investigator in Immunic's multiple sclerosis (MS) programs and receives consulting fees for serving as an advisor to Immunic.

Key Points: 
  • Dr. Fox has served as Coordinating Investigator in Immunic's multiple sclerosis (MS) programs and receives consulting fees for serving as an advisor to Immunic.
  • "We eagerly await reporting data from our ongoing phase 3 ENSURE program in relapsing MS as well as our ongoing phase 2 CALLIPER trial in progressive MS.
  • EMPhASIS is an international, multicenter, double-blind, placebo-controlled, randomized, parallel-group trial, designed to assess the efficacy and safety of vidofludimus calcium in patients with RRMS.
  • The trial included a 24-week blinded main treatment period testing 10, 30 and 45 mg of vidofludimus calcium and placebo.

EQS-News: Immunic Presents Data From Phase 2 EMPhASIS Trial of Vidofludimus Calcium in Relapsing-Remitting Multiple Sclerosis at ACTRIMS Forum 2023

Retrieved on: 
Mittwoch, Februar 22, 2023

Dr. Fox has served as Coordinating Investigator in Immunic’s multiple sclerosis (MS) programs and receives consulting fees for serving as an advisor to Immunic.

Key Points: 
  • Dr. Fox has served as Coordinating Investigator in Immunic’s multiple sclerosis (MS) programs and receives consulting fees for serving as an advisor to Immunic.
  • “We eagerly await reporting data from our ongoing phase 3 ENSURE program in relapsing MS as well as our ongoing phase 2 CALLIPER trial in progressive MS.
  • EMPhASIS is an international, multicenter, double-blind, placebo-controlled, randomized, parallel-group trial, designed to assess the efficacy and safety of vidofludimus calcium in patients with RRMS.
  • The trial included a 24-week blinded main treatment period testing 10, 30 and 45 mg of vidofludimus calcium and placebo.

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

Retrieved on: 
Donnerstag, Februar 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 .