Oral new medicine for multiple sclerosis! Next-generation selective immunomodant IMU-838: significant efficacy, good safety!

August 06, 2020 // -- Immunic Therapeutics is a clinical biopharmaceutical company focused on developing best-in-class oral therapies for chronic inflammatory and autoimmune diseases.
, the company recently released positive topline data from its pilot asset, IMU-838, for the treatment of recurrent-relieving multiple sclerosis (RRMS) Phase II EMPhASIS.
data show that the study reached all major and critical secondary endpoints, confirming that IMU-838 treatment RRMS has significant efficacy and good safety and tolerance.
these results support the potential of IMU-838 to provide rRRMS patients with a new, convenient, every, oral first-line treatment.
IMU-838 is an oral next-generation selective immunomodulant that inhibits intracellular metabolism of active immune cells by blocking the dehydrogenase (DHODH) of bihydroglotonic acid.
IMU-838 acts on active T- and B-cells while keeping other immune cells largely intact and keeping the immune system functioning, such as fighting infection.
previous trials, IMU-838 did not increase infection rates compared to placebos.
addition, DHODH inhibitors, such as IMU-838, are known to have host-based antiviral effects that are independent of specific viral proteins and their structure.
, DHODH inhibition can be widely used in a variety of viruses.
2017, two Phase I clinical trials of IMU-828 were successful.
In addition to developing IMU-838 for the treatment of RCMS patients, Immunic is also conducting a number of Phase II clinical trials to evaluate IMU-838 for the treatment of new coronavirus pneumonia (COVID-19), primary sclerosing bile ductitis (PSC), ulcerative colitis (UC), data expected to be released in the coming months.
IMU-838 Structural and DHODH Inhibition (click on the image for a large picture) EMPhASIS is an international, multi-center, double-blind, placebo-controlled, randomized, parallel group study designed to evaluate the efficacy and safety of IMU-838 in treating RRRMS patients.
of the 210 patients in the 36 centres in four European countries, 209 received at least one dose of IMU-838 or placebo (placebo group n?69; 30mg IMU-838 group n?71; 45mg IMU-838 group n-69, once daily), and 197 patients completed a 24-week course of treatment blind.
according to the recurrent clinical evidence and other magnetic resonance imaging (MRI) standards, all patients in the group must show disease activity.
main endpoints and key secondary endpoints were the cumulative number of combined independent active (CUA) magnetic resonance imaging (MRI) lesions in the IMU-838 45mg and 30mg groups over a 24-week blind treatment.
MRI examinations were performed at baseline checks at 6, 12, 18 and 24 weeks and were centrally evaluated by an independent blind MRI reader.
study included an optional extended treatment period of up to 9.5 years to assess the long-term safety and tolerability of IMU-838.
results showed that the study reached a major endpoint: within 24 weeks of treatment, the cumulative number of combined independent magnetic resonance imaging (CUA-MRI) lesions in patients in the 45 mg dose group decreased significantly by 62% compared to the placebo group.
the study also reached a critical secondary endpoint: a significant 70 percent reduction in cuA-MRI lesions in patients in the 30 mg dose group compared to the placebo group.
All other secondary endpoints, including secondary endpoints based on other MRI parameters and clinical endpoints such as recurrence events, showed significant signaling and numerical benefits in the two doses of IMU-838 compared to the placebo group.
data from other patient groups, the IMU-838 drug was observed in the study to be safe and well tolerated.
patients treated with IMU-838, the rate of adverse events caused by treatment was 42.9 percent, compared with 43.5 percent in the placebo group.
, serious adverse events caused by treatment were rare, with only 3 out of 140 patients treated with IMU-838, and only 1 out of 69 patients taking placebos.
the IMU-838 treatment group had an opt-out rate of only 5.0 percent and the placebo group 7.2 percent during the 24-week blind treatment period.
addition, the rate of drug suspension due to adverse events or programme-mandated drug suspension standards was equal between the combined IMU-838 treatment group and the placebo group.
there was no increase in liver or kidney events in the IMU-838 treatment group compared to the placebo group.
analysis of all key data is under way and will be presented at an upcoming scientific conference. "In the EMPhASIS trial, subjects treated with IMU-838 showed a strong response at the end of all studies analyzed at the top line," said Dr. Andreas Muehler, Chief Medical Officer,
Immunic.
in addition to using different measurements to demonstrate consistent activity in IMU-838 in RRRMS, the study data support previously observed good safety and tolerance of IMU-838 in RRRMS patients.
we believe this data strongly supports our goal of developing IMU-838 as a simple, safe and convenient oral treatment for patients with RRRMS and other autoimmune diseases.
are very encouraged by these results and now intend to focus on the development program with the goal of ultimately making IMU-838 the best, daily oral therapy for RRRMS.
() Source: Immunic, Inc. Reports Positive Top-line Data From Phase 2 EMPhASIS Trial of IMU-838 in Patients and Relapsing-Remitting Multiple Sclerosis.