IMU-838

DGAP-News: Immunic, Inc. Announces First Patients Dosed in its Phase 2, CALVID-1 Clinical Trial of IMU-838 in COVID-19

Retrieved on: 
Monday, June 15, 2020
Medical specialties, Medicine, Health, Immunosuppressants, Colitis, Diarrhea, RTT, Ulcerative colitis, Clinical trial, Tcelna, Corinne Goldsmith Dickinson Center for Multiple Sclerosis, IMU-838, Immunic, Inc.

Announces First Patients Dosed in its Phase 2, CALVID-1 Clinical Trial of IMU-838 in COVID-19

Key Points: 
  • Announces First Patients Dosed in its Phase 2, CALVID-1 Clinical Trial of IMU-838 in COVID-19
    The issuer is solely responsible for the content of this announcement.
  • Patients will be enrolled at 10 to 35 centers in Germany, the United States and a half dozen European countries.
  • It is a prospective, multicenter, randomized, placebo-controlled, double-blind clinical trial in patients with moderate COVID-19, designed to evaluate efficacy, safety and tolerability of IMU-838.
  • 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.

DGAP-News: Immunic, Inc. Announces U.S. Food and Drug Administration Allowance of its Phase 2, CALVID-1 Clinical Trial of IMU-838 in COVID-19

Retrieved on: 
Tuesday, June 9, 2020
Health, Clinical research, Medical specialties, Design of experiments, Medicine, Clinical trials, Pharmaceutical industry, Placebo-controlled study, Primary sclerosing cholangitis, IMU-838, Immunic, Inc.

Announces U.S. Food and Drug Administration Allowance of its Phase 2, CALVID-1 Clinical Trial of IMU-838 in COVID-19

Key Points: 
  • Announces U.S. Food and Drug Administration Allowance of its Phase 2, CALVID-1 Clinical Trial of IMU-838 in COVID-19
    The issuer is solely responsible for the content of this announcement.
  • It is a prospective, multicenter, randomized, placebo-controlled, double-blind clinical trial in patients with moderate COVID-19, designed to evaluate efficacy, safety and tolerability of IMU-838.
  • For more information on this clinical trial, please visit: www.clinicaltrials.gov , NCT04379271.
  • An investigator-sponsored proof-of-concept clinical trial for IMU-838 in primary sclerosing cholangitis is ongoing at the Mayo Clinic.

DGAP-News: Immunic, Inc. Receives First Regulatory Approval from German Health Authority BfArM to Initiate a Phase 2 Clinical Trial of its Selective Oral DHODH Inhibitor, IMU-838, in COVID-19 Patients

Retrieved on: 
Wednesday, May 13, 2020
Viruses, Coronaviridae, Zoonoses, Animal virology, Coronavirus, Severe acute respiratory syndrome-related coronavirus, Severe acute respiratory syndrome, Dihydroorotate dehydrogenase, IMU-838, Immunic, Inc.

Immunic, Inc. Receives First Regulatory Approval from German Health Authority BfArM to Initiate a Phase 2 Clinical Trial of its Selective Oral DHODH Inhibitor, IMU-838, in COVID-19 Patients

Key Points: 
  • Immunic, Inc. Receives First Regulatory Approval from German Health Authority BfArM to Initiate a Phase 2 Clinical Trial of its Selective Oral DHODH Inhibitor, IMU-838, in COVID-19 Patients
    The issuer is solely responsible for the content of this announcement.
  • Immunic recently announced that IMU-838 had successfully demonstrated preclinical activity against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
  • In addition, IMU-838 has an attractive pharmacokinetic, safety and tolerability profile and, to date, has already been tested in about 650 individuals.
  • The trial is expected to initially enroll approximately 230 patients at 10-35 centers across Europe and the United States.

DGAP-News: Immunic, Inc. Reports that IMU-838, a Selective Oral DHODH Inhibitor, Has Demonstrated Preclinical Activity Against SARS-CoV-2 and Explores Plans for a Phase 2 Clinical Trial in COVID-19 Patients

Retrieved on: 
Tuesday, April 21, 2020
Medical specialties, Medicine, Viruses, Autoimmune diseases, Coronaviridae, Animal virology, Zoonoses, Coronavirus, Severe acute respiratory syndrome-related coronavirus, Ulcerative colitis, Antiviral drug, Primary sclerosing cholangitis, IMU-838, Immunic, Inc.

More specifically, IMU-838 was observed to inhibit replication of clinical isolates of SARS-CoV-2 associated with coronavirus disease 2019 (COVID-19).

Key Points: 
  • More specifically, IMU-838 was observed to inhibit replication of clinical isolates of SARS-CoV-2 associated with coronavirus disease 2019 (COVID-19).
  • In addition, DHODH inhibitors may help reduce the severity or virulence of infection through several mechanisms.
  • IMU-838 is already being investigated in ongoing phase 2 clinical trials in patients with relapsing-remitting multiple sclerosis, ulcerative colitis and primary sclerosing cholangitis.
  • "The broad antiviral activity of IMU-838 has been well documented and preclinical testing affirms the antiviral activity of IMU-838 against SARS-CoV-2.