Immunic Therapeutics Fully Enrolls Phase 2 Trial of Oral IMU-838, Potential RRMS Treatment

Immunic Therapeutics Fully Enrolls Phase 2 Trial of Oral IMU-838, Potential RRMS Treatment

Immunic Therapeutics announced that a Phase 2 clinical trial of IMU-838, its experimental oral therapy for relapsing-remitting multiple sclerosis (RRMS), is fully enrolled ahead of schedule.

The trial, called EMPhASIS, also exceeded its target number of participants: Immunic set an initial recruitment goal of 195 patients by mid-2020, and enrolled 210 at sites across four European countries.

“Achievement of this milestone for our lead program, IMU-838, in RRMS, substantially ahead of prior expectations, reflects not only our team’s strength in executing on the company’s drug development strategy, but also the urgent need from patients for a safer oral treatment option,” Daniel Vitt, PhD, Immunic’s CEO and president, said in a press release.

IMU-838 (vidofludimus calcium) is a small, selective immunomodulator being developed, as an oral tablet, to treat RRMS, inflammatory bowel disease (IBD), and other chronic inflammatory and autoimmune diseases. It works by blocking an enzyme called dihydroorotate dehydrogenase (DHODH), which dampens inflammation mediated by immune T- and B-cells.

Immunic suggests that a key advantage of DHODH inhibition is its selectivity toward metabolically active immune cells, leaving other bone marrow cells unaffected.

The approved MS therapy Aubagio (teriflunomide, by Sanofi Genzyme) also works by inhibiting DHODH.

EMPhASIS  (NCT03846219) will evaluate the safety and efficacy of two oral doses of IMU-838 (30 or 45 mg/day) given once daily against placebo in RRMS patients for 24 weeks. All enrolled in the trial have evidence of active disease, as assessed through clinical evidence of relapse and signs of active lesions (gadolinium positive) on magnetic resonance imaging (MRI) scans.

Patients were enrolled at 36 centers across Romania, Bulgaria, Ukraine, and Poland starting in February.

The primary efficacy measure is the effects of treatment on disease progression, based on the cumulative number of combined unique active MRI lesions up to week 24.

Those completing the trial can choose to continue or start treatment (placebo group) in an open-label extension study meant to assess the long-term safety and tolerability of IMU-838.

Top-line study results are anticipated to become available during the third quarter of 2020.

Two Phase 1 studies of single or repeated once-daily doses of IMU-838 in healthy volunteers were done in 2017, and showed repeated daily doses of up to 50 mg of the potential therapy were safe and tolerable.

“Backed by newly released preclinical data confirming the superior profile of IMU-838 versus the currently approved DHODH inhibitor, teriflunomide [Aubagio], we remain highly enthusiastic about the potential of IMU-838 to become an important new best-in-class oral therapeutic treatment alternative for patients with RRMS,” Vitt said.

IMU-838 is also being investigated as a treatment for ulcerative colitis (a form of IBD) in a Phase 2 trial, and as a treatment for primary sclerosing cholangitis (a disease of the bile ducts) in a proof-of-concept trial.

Ana is a molecular biologist with a passion for discovery and communication. As a science writer she looks for connecting the public, in particular patient and healthcare communities, with clear and quality information about the latest medical advances. Ana holds a PhD in Biomedical Sciences from the University of Lisbon, Portugal, where she specialized in genetics, molecular biology, and infectious diseases
Total Posts: 1,053
Patrícia holds her PhD in Medical Microbiology and Infectious Diseases from the Leiden University Medical Center in Leiden, The Netherlands. She has studied Applied Biology at Universidade do Minho and was a postdoctoral research fellow at Instituto de Medicina Molecular in Lisbon, Portugal. Her work has been focused on molecular genetic traits of infectious agents such as viruses and parasites.
×
Ana is a molecular biologist with a passion for discovery and communication. As a science writer she looks for connecting the public, in particular patient and healthcare communities, with clear and quality information about the latest medical advances. Ana holds a PhD in Biomedical Sciences from the University of Lisbon, Portugal, where she specialized in genetics, molecular biology, and infectious diseases
Latest Posts
  • Acthar Gel study
  • NfL blood test
  • Lemtrada and safety risks
  • vision loss and mutations
Average Rating
5 out of 5 stars. 1 votes.
My Rating:

Leave a Comment

Your email address will not be published. Required fields are marked *

Pin It on Pinterest

Share This