IMU-838

DGAP-News: Immunic, Inc. Announces Completion of Enrollment of its Phase 2 CALDOSE-1 Trial of IMU-838 in Moderate-to-Severe Ulcerative Colitis

Retrieved on: 
Thursday, October 28, 2021
Safety, NEW, Endoscopy, Drug development, Mayo Clinic, Infection, Security (finance), Ulcerative colitis, U.S. Securities and Exchange Commission, Patient, Private Securities Litigation Reform Act, Psoriasis, DHODH, Multiple sclerosis, SEC, Degenerative disease, Nature, Primary sclerosing cholangitis, Annual report, Risk, Clinical trial, UC, COVID-19, Metabolism, Immune system, Crohn's disease, Pharmaceutical industry, Vaccine, IMU-838, Immunic, Inc., IMU-838, IMMUNIC, INC.

Top-line data for the induction phase is expected to be available in the second quarter of 2022.

Key Points: 
  • Top-line data for the induction phase is expected to be available in the second quarter of 2022.
  • We look forward to obtaining the unblinded top-line data in the second quarter of next year."
  • The phase 2 CALDOSE-1 trial is a multicenter, randomized, double-blind, placebo-controlled, dose-finding study being conducted at more than 100 sites in 19 countries, including the United States and Western, Central and Eastern Europe.
  • IMU-838 was successfully tested in two phase 1 clinical trials in 2017 and is currently being tested in a phase 2 trial in patients with ulcerative colitis.

DGAP-News: Immunic, Inc. Enrolls First Patient in Its Phase 2 CALLIPER Trial of IMU-838 in Progressive Multiple Sclerosis

Retrieved on: 
Thursday, September 30, 2021
Optic nerve, Clinical trial, Nature, Lists of diseases, EDSS, RRMS, Serum, Risk, Annual report, Infection, Degenerative disease, Primary sclerosing cholangitis, Security (finance), Private Securities Litigation Reform Act, U.S. Securities and Exchange Commission, PPMS, Patient, Multiple sclerosis, Population, Crohn's disease, Central nervous system, Biomarker, Spinal cord, Metabolism, Immune system, PMS, MS, Disability, Psoriasis, Disease, COVID-19, Ulcerative colitis, Muscle atrophy, Drug development, Brain, SPMS, Mayo Clinic, Safety, Autoimmune disease, DHODH, NEW, SEC, AFL, Pharmaceutical industry, Medical imaging, Vaccine, Progressive Multiple Sclerosis, IMU-838, Immunic, Inc., PROGRESSIVE MULTIPLE SCLEROSIS, IMU-838, IMMUNIC, INC.

The trial, which is intended to run concurrently with and as a complement to the company's twin phase 3 ENSURE trials in relapsing-remitting multiple sclerosis (RRMS), is focused on progressive forms of multiple sclerosis (MS) and designed to corroborate IMU-838's neuroprotective potential in this patient population.

Key Points: 
  • The trial, which is intended to run concurrently with and as a complement to the company's twin phase 3 ENSURE trials in relapsing-remitting multiple sclerosis (RRMS), is focused on progressive forms of multiple sclerosis (MS) and designed to corroborate IMU-838's neuroprotective potential in this patient population.
  • If the CALLIPER trial is successful in showing beneficial data, we believe this could be an essential differentiator for IMU-838 in the MS market."
  • Multiple sclerosis (MS) is an autoimmune disease that affects the brain, spinal cord and optic nerve.
  • Progressive multiple sclerosis (PMS) includes both primary progressive MS (PPMS) and secondary progressive MS (SPMS).

DGAP-News: Immunic and the University Medical Center Goettingen Sign License Agreement Covering the Combination of DHODH Inhibitors and Nucleoside Analogues to Treat Viral Infections, Including COVID-19

Retrieved on: 
Wednesday, September 22, 2021
MSD, Combination, NEW, Clinical trial, Nature, Molecular oncology, Merck & Co., Partnership, Research, Risk, RNA, Annual report, Degenerative disease, Pandemic, Infection, Primary sclerosing cholangitis, Private Securities Litigation Reform Act, Doctor of Philosophy, U.S. Securities and Exchange Commission, Patient, NHC, Detection limit, University Hospitals of the Ruhr-University of Bochum, Crohn's disease, MBM, Metabolism, Immune system, Nucleoside, Merck, LLC, Program, Utah State University, Psoriasis, Security (finance), COVID-19, Technology, Ulcerative colitis, Human, Severe acute respiratory syndrome coronavirus 2, Drug development, Mayo Clinic, Safety, DHODH, Multiple sclerosis, DRIVE, SEC, Viral disease, Pharmaceutical industry, Vaccine, IMU-838, Immunic, Inc., IMU-838, IMMUNIC, INC.

Immunic and the University Medical Center Goettingen Sign License Agreement Covering the Combination of DHODH Inhibitors and Nucleoside Analogues to Treat Viral Infections, Including COVID-19- Preclinical Combination Data Suggests Extra-Ordinary Synergy Between Certain DHODH Inhibitors and Nucleoside Analogues -- Combination of IMU-838 and N4-Hydroxycytidine Reduced SARS-CoV-2 Virus Levels, Including the Delta Variant, Down to the Detection Limit -NEW YORK and GOETTINGEN, Germany, September 22, 2021 - 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 the execution of an in-license agreement with the University Medical Center Goettingen, Germany, covering the combination of DHODH inhibitors and nucleoside analogues to treat viral infections (COVID-19 and Influenza). Terms of the agreement were not disclosed.
Preclinical research recently completed by the parties and their collaborators[1] has shown that certain DHODH inhibitors, including Immunic's lead asset, IMU-838, strongly synergize with selected nucleoside analogues to inhibit SARS-CoV-2 replication in vitro. For instance, in an in vitro test system, IMU-838 alone showed an up to 99.9% reduction in viral RNA at concentrations of 5 μM, which is well within the exposure levels seen in prior clinical trials. Likewise, N4-hydroxycytidine (NHC), the active metabolite of molnupiravir[2], alone, was associated with an up to 99% reduction in viral RNA at concentrations of 100 nM. Compared to single agent activity, the combination of IMU-838 and NHC achieved an extra-ordinary reduction in viral RNA, down to the limit of detection, reducing SARS-CoV-2 RNA by up to seven log units (corresponding to 0.00001% viral RNA remaining). This powerful reduction of virus replication in vitro was demonstrated across multiple SARS-CoV-2 variants, including alpha, beta and delta, highlighting the independence of this approach to mutant virus forms. In addition to molnupiravir, Immunic is exploring alternate nucleoside analogues, some of which have shown very promising antiviral activity in vitro. The company plans to present detailed data at an upcoming scientific conference.
"Research by the University Medical Center Goettingen and other research partners revealed a profound degree of synergy in vitro when combining certain nucleoside analogues with DHODH inhibitors, including both our lead asset IMU-838 and other of our preclinical molecules," stated Daniel Vitt, Ph.D., Chief Executive Officer and President of Immunic. "Recalling IMU-838's clinical activity against COVID-19 in our phase 2 CALVID-1 trial published earlier this year, and in light of recent exacerbations in COVID-19, worldwide, we are very excited to have in-licensed this technology to incorporate into our pandemic preparedness effort. However, with the extra-ordinary wealth of activity already ongoing at the company in other programs, we intend to evaluate and pursue the best possible strategic option for this program, including potential partnership, collaboration or external funding."

Key Points: 
  • Immunic and the University Medical Center Goettingen Sign License Agreement Covering the Combination of DHODH Inhibitors and Nucleoside Analogues to Treat Viral Infections, Including COVID-19
    The issuer is solely responsible for the content of this announcement.
  • In addition to molnupiravir, Immunic is exploring alternate nucleoside analogues, some of which have shown very promising antiviral activity in vitro.
  • Matthias Dobbelstein, M.D., Professor of Molecular Oncology, University Medical Center Goettingen, added, "We are proud of the results of our preclinical work.
  • Although the technology in-licensed by Immunic includes the potential combination of DHODH inhibitors with nucleoside analogues, including molnupiravir, Immunic does not have any rights to molnupiravir itself.

DGAP-News: Immunic, Inc. Announces Positive Top-Line Data From Investigator-Sponsored Phase 2 Proof-of-Concept Clinical Trial of IMU-838 in Primary Sclerosing Cholangitis

Retrieved on: 
Thursday, February 18, 2021
Medical specialties, Health, Medicine, Hepatology, Primary sclerosing cholangitis, Clinical trial, Ascending cholangitis, Primary Sclerosing Cholangitis (PSC), IMU-838, Immunic, Inc.

The results from this small, open-label study suggest that IMU-838 merits further clinical testing in PSC.

Key Points: 
  • The results from this small, open-label study suggest that IMU-838 merits further clinical testing in PSC.
  • We are in discussions with investigators and leading clinical experts to further evaluate the data set and to explore potential next steps for this indication."
  • This positive primary outcome was achieved by 3 of 11 patients in the PP population (27.3%, 95% CI: 6-61%).
  • Also, in the first quarter of 2021, the company reported positive top-line data from an investigator-sponsored phase 2 proof-of-concept clinical trial of IMU-838 in primary sclerosing cholangitis which was conducted in collaboration with Mayo Clinic.

DGAP-News: Immunic, Inc. Announces That Oral Treatment IMU-838 Shows Evidence of Clinical Activity in Moderate COVID-19 in Phase 2 CALVID-1 Trial

Retrieved on: 
Wednesday, February 17, 2021
Health sciences, Health, Medicine, Medical research, Vaccines, Clinical research, Drug discovery, Pharmaceutical industry, COVID-19 drug repurposing research, Tcelna, IMU-838, Immunic, Inc.

"The reductions in hospitalization and clinical recovery times observed thus far in our CALVID-1 trial are clinically meaningful, and particularly interesting in the high-risk and elderly populations.

Key Points: 
  • "The reductions in hospitalization and clinical recovery times observed thus far in our CALVID-1 trial are clinically meaningful, and particularly interesting in the high-risk and elderly populations.
  • In parallel, we plan to explore options for the further development of IMU-838 in this indication and for funding support."
  • The prospective, multicenter, randomized, placebo-controlled, double-blind phase 2 trial was designed to evaluate efficacy, safety and tolerability of IMU-838 in patients with moderate COVID-19.
  • In the first quarter of 2021, Immunic announced that IMU-838 has shown evidence of clinical activity in its phase 2 CALVID-1 trial in hospitalized patients with moderate COVID-19.

DGAP-News: Immunic, Inc. Announces 200 Patients Enrolled in Its Phase 2 CALVID-1 Trial of IMU-838 for the Treatment of Moderate COVID-19, Allowing for Main Phase 2 Efficacy Analysis to Proceed

Retrieved on: 
Monday, November 2, 2020
Medical specialties, Clinical medicine, Immunology, Autoimmune diseases, Abdominal pain, Colitis, Monoclonal antibodies, Diarrhea, Ulcerative colitis, Crohn's disease, IMU-838, Immunic, Inc.

Announces 200 Patients Enrolled in Its Phase 2 CALVID-1 Trial of IMU-838 for the Treatment of Moderate COVID-19, Allowing for Main Phase 2 Efficacy Analysis to Proceed

Key Points: 
  • Announces 200 Patients Enrolled in Its Phase 2 CALVID-1 Trial of IMU-838 for the Treatment of Moderate COVID-19, Allowing for Main Phase 2 Efficacy Analysis to Proceed
    The issuer is solely responsible for the content of this announcement.
  • The current part of CALVID-1 is defined as a phase 2 proof-of-activity trial.
  • No formal statistical analysis was pre-specified for this main analysis and all endpoints will be analyzed descriptively.
  • IMU-838 is also in phase 2 clinical development for ulcerative colitis and COVID-19, with an additional phase 2 trial considered in Crohn's disease.

DGAP-News: Immunic, Inc. Announces Results From Interim Safety Analysis and Recruitment Update From Its Ongoing Phase 2 CALVID-1 Trial of IMU-838 in Patients With Moderate COVID-19

Retrieved on: 
Monday, September 28, 2020
IDMC, Clinical research, Design of experiments, Drug discovery, Pharmaceutical industry, IMU-838, Immunic, Inc.

Based on the available safety data, an Independent Data Monitoring Committee (IDMC) has concluded that the study should continue without changes.

Key Points: 
  • Based on the available safety data, an Independent Data Monitoring Committee (IDMC) has concluded that the study should continue without changes.
  • This interim safety analysis and the conclusions made by the IDMC may not reflect results of a final analysis of the trial once the full data set is analyzed.
  • The trial is expected to initially enroll approximately 230 patients at 10-35 centers across Europe and the United States.
  • Patients in both arms are also eligible to receive investigator's choice of standard-of-care therapy throughout the duration of the study.

DGAP-News: Immunic, Inc. Publishes Full Unblinded Clinical Data From Phase 2 EMPhASIS Trial of IMU-838 in Patients With Relapsing-Remitting Multiple Sclerosis and Announces Poster Presentation at the MSVirtual2020

Retrieved on: 
Friday, September 11, 2020
Fox Broadcasting Company, Metromedia, Relapsing-Remitting Multiple Sclerosis, IMU-838, Immunic, Inc.

Fox, M.D., Staff Neurologist, Mellen Center for Multiple Sclerosis, Vice-Chair for Research, Neurologic Institute, Cleveland Clinic, Cleveland, Ohio.

Key Points: 
  • Fox, M.D., Staff Neurologist, Mellen Center for Multiple Sclerosis, Vice-Chair for Research, Neurologic Institute, Cleveland Clinic, Cleveland, Ohio.
  • The poster presentation, including Dr. Fox's audio track, will be published today at 8:00 am ET in the MSVirtual2020 E-Poster Hall.
  • Dr. Fox receives compensation as a chair of the steering committee for the EMPhASIS trial.
  • As previously announced, the phase 2 EMPhASIS trial achieved all primary and key secondary endpoints.

DGAP-News: Immunic, Inc. Reports Positive Top-line Data from Phase 2 EMPhASIS Trial of IMU-838 in Patients with Relapsing-Remitting Multiple Sclerosis

Retrieved on: 
Sunday, August 2, 2020
Health, Clinical research, Design of experiments, Medical research, Clinical trials, Placebo-controlled study, Tcelna, Draft:Remune™, Relapsing-Remitting Multiple Sclerosis, IMU-838, Immunic, Inc.

"Patients in the EMPhASIS trial exhibited robust responses across all study endpoints included in the top-line analysis.

Key Points: 
  • "Patients in the EMPhASIS trial exhibited robust responses across all study endpoints included in the top-line analysis.
  • The phase 2 EMPhASIS trial was an international, multicenter, double-blind, placebo-controlled, randomized, parallel-group study, designed to assess the efficacy and safety of IMU-838 in patients with RRMS.
  • All enrolled patients were required to have shown disease activity based on clinical evidence of relapse and additional MRI criteria.
  • - June 2020: Dosed the first patients in CALVID-1 clinical trial, a prospective, multicenter, randomized, placebo-controlled, double-blind phase 2 trial of IMU-838 in patients with moderate COVID-19.

DGAP-News: Immunic, Inc. Announces First Patients Enrolled in Investigator-Sponsored Phase 2 Clinical Trial of IMU-838 in Combination with Oseltamivir for the Treatment of Patients with Moderate-to-Severe COVID-19

Retrieved on: 
Monday, July 27, 2020
Medical specialties, Clinical medicine, Medicine, Autoimmune diseases, Abdominal pain, RTT, Colitis, Diarrhea, Ulcerative colitis, Primary sclerosing cholangitis, Crohn's disease, Coronavirus disease, IMU-838, Immunic, Inc., UHCW NHS Trust

"Recent third-party research has highlighted the powerful synergy between direct antiviral drugs and DHODH inhibitors in preclinical models.

Key Points: 
  • "Recent third-party research has highlighted the powerful synergy between direct antiviral drugs and DHODH inhibitors in preclinical models.
  • Specifically, IMU-838 was observed to inhibit replication of clinical isolates of SARS-CoV-2 associated with COVID-19.
  • Furthermore, Immunic's collaboration partner, the Mayo Clinic, has started an investigator-sponsored proof-of-concept clinical trial testing IMU-838 activity in patients with primary sclerosing cholangitis.
  • IMU-838 is in phase 2 clinical development for COVID-19, relapsing-remitting multiple sclerosis and ulcerative colitis, with an additional phase 2 trial considered in Crohn's disease.