MediciNova Launches Phase 2b/3 Trial of Ibudilast for ALS

MediciNova Launches Phase 2b/3 Trial of Ibudilast for ALS

MediciNova has launched the Phase 2b/3 clinical trial that will explore the potential of ibudilast (MN-166) in patients with amyotrophic lateral sclerosis (ALS).

Pending the success of the trial, the collected data will support the submission of a new drug application and the approval of ibudilast for the treatment of ALS, the company hopes.

The trial is expected to start enrolling patients soon across several sites in the U.S. “We are very pleased to achieve this milestone and look forward to initiating patient enrollment shortly,” Yuichi Iwaki, MD, PhD, president and CEO of MediciNova, said in a press release.

It will recruit approximately 150 participants who have had ALS for no more than 18 months with mild disability, determined by a score of at least 35 on the Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R) at screening.

Patients taking Radicava (edaravone) or Nuedexta (dextromethorphan/quinidine) may also be eligible to participate in the study if they discontinue treatments three months before entering the trial.

Participants will initiate treatment with Rilutek (riluzole) for at least 30 days, after which they will start taking either 100 mg per day of ibudilast or a placebo for a period of nine months.

During the trial, researchers will evaluate the impact of ibudilast in ALS progression and patients’ functional disability by determining changes in ALSFRS-R score at the end of the treatment period. In addition to this primary goal, they will also assess changes in patients’ muscle strength, quality of life, and respiratory function, as well as the safety and tolerability profile of ibudilast.

Ibudilast is a small molecule that was designed to inhibit the activity of PDE4 and PDE10 enzymes and of MIF protein. This broad approach is thought to reduce the activity of immune cells in the brain and increase the production of neurotrophic factors that support the survival and growth of nerve cells that control movement.

This investigational therapy has been granted fast track status and orphan drug designation by the U.S. Food and Drug Administration for the treatment of ALS. These designations are intended to expedite and support its clinical development, review, and potential approval.

Ibudilast’s benefits in ALS have been explored in a previous Phase 2 trial (NCT02238626) in combination with Rilutek.

Results showed that add-on treatment with ibudilast could significantly improve functional activity and quality of life in ALS patients compared with Rilutek alone. The combo therapy could also delay disease worsening and improve survival rates.

MediciNova is exploring the impact of ibudilast administered alone to ALS patients in a Phase 1/2 trial (NCT02714036). This trial has already completed patient enrollment and is ongoing.

17 comments

    • David Buschhorn says:

      Yeah you rebel. How dare you live so long. 😉

      I think they’re looking for people who are fairly newly diagnosed and not yet incapacitated.

      I’ve had it for 8 years and can still walk around, drive my manual transmission car, carry boxes and stuff, but my dexterity in my hands is shot. I can’t breathe without a trach and food come via tube. Also, I’m completely mute.

      • Benjamin Blumberg says:

        Have you heard about The Marshall Protocol? This is an alternative treatment method based on the idea that some forms of ALS are caused by bacteria esp Streptococcus B and involves alternating rounds of antibiotic followed by the drug Benicar. antibiotic kills some but not all bacteria, which go into metabolic stealth state controlled by innate immune system. Bencher, antagonizes innate immune hold via vitamin D receptor, allows bacteria to regrow, etc, etc. The problem with this Protocol is that many rounds of antibiotic/Benicar may be needed. At 2 weeks per round, with 50 rounds, treatment may take 2+ years. Not many MDs are willing to promote a protocol that takes this long based on faith.

  1. Sherry Reid says:

    I have been suffering from amyotrophic laterals sclerosis (ALS) disease for the last three years and had constant pain, especially in my knees.I was tripping and unable to get upstairs due to (ALS), My doctor put me on riluzole, letting me know there was no cure but the medication might provide me a few more months of delayed symptoms.The Rilutek (riluzole) did very little to help me. The medical team did even less. My decline was rapid and devastating. The psychological support from the medical centre was non-existent and if it were not for the sensitive care and attention of my primary physician, I would have died. There has been little if any progress in finding a cure. With the help of Organic Clinic natural herbs I have been able to reverse my symptoms using herbs, which i feel has made the most difference. The ALS natural formula immensely helped my condition, it reversed my ALS. my slurred speech. And then the inability to eat without getting choked, and the Pains. gradually disappeared. Visit Organic Herbal Clinic via their official web-site www. organicherbalclinic. com. I’m now playing golf again. and i turned 68 today. DON’T GIVE UP HOPE!!

  2. BETTY says:

    I HAVE PLS BUT DOCTORS REFUSE TO TEST ME AGAIN. MY LEGS ARE VERY STIFF AND MY VOICE IS GETTING WORSE EVERY YEAR. WHY CANT I QUALIFY FOR CLINICAL TRIALS NOT THAT IVE BEEN DENIED BUT WITH PLS DONT KNOW IF I QUALIFY. THIS DISEASE HAS TAKEN THE TWO MOST IMPORTANT PARTS OF MY BODY.

  3. Mike says:

    You can buy ibudilast from overseas. Your neuro just has to write a script for you. Just look it up in (social medwork.

    It’s called ketas in Japan.

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