Neuraltus Completes Enrollment in Second Phase 2 Trial of NP001 for Treating ALS Inflammation

Neuraltus Completes Enrollment in Second Phase 2 Trial of NP001 for Treating ALS Inflammation

Neuraltus Pharmaceuticals has completed enrollment its Phase 2 confirmatory study of NP001 (NCT02794857) in ALS patients with systemic inflammation.

The company expects the last patient in the trial to be assessed in early 2018 and to release the study’s  results in the first months of the year.

“Reaching the completion of enrollment in the confirmatory Phase 2 study of NP001 is a significant milestone for ALS patients, clinical investigators, and our team,” Rich Casey, Neuraltus Pharmaceuticals’ chief executive officer, said in a news release. “Over the past 20 years, only two therapeutic agents have been approved to treat patients with ALS, a rare condition with a significant unmet need. We plan to request a meeting with the FDA to review all of the NP001 clinical and pharmacology data and, if the results are positive, discuss the required next steps to advance NP001” toward regulatory approval.

Researchers recruited 138 amyotrophic lateral sclerosis patients to confirm the findings of a previous Phase 2 study (NCT01281631), which showed that NP001 slowed the disease’s progression in people with high levels of inflammation. The team published the study, titled “Randomized phase 2 trial of NP001, a novel immune regulator,” in the journal Neurology: Neuroimmunology & Neuroinflammation.

In the new trial, patients will receive NP001 or a placebo for six months. The dosing will come during five consecutive days in the first month, and three consecutive days in the following months.

The study’s primary objective is to see to whether NP001 improves patients’ ALS Functional Rating Score Revised, a measure of patients’ ability to carry out daily activities. Researchers will also evaluate other parameters, such as improvement in lung function, and the treatment’s safety and tolerability.

ALS is a neurodegenerative disease marked by loss of motor neurons, or those that control muscles. Inflammation is thought to play a role in the progression of ALS. Neuraltus believes NP001 fights neuro-inflammation by controlling immune cells’ ability to enter the brain.

10 comments

  1. Karen says:

    This trial could have been filled a long time ago if they didn’t make it so difficult for people to enroll.; they are and have been playing with people’s lives. Makes me angry.

    • Louis Rambin says:

      I agree totally. Why can’t ALS research receive more donations and grants similar to other research. Me and other victims are desperate for some medications that halt ALS not just slow it down 10%. The future for victims is horrible to think about and so sad for family and friends to watch.

      • Karen says:

        If it was their families they would get the best treatment as fast as possible but the rest don’t seem to matter.

      • Charlie says:

        Far more people get cancer, have strokes and develop heart trouble than ALS, so politicians, who control much of the research money, will allocate it in proportion to patient numbers. Nothing coming out of the research labs has yet proven to stop or reverse symptoms. Research into ALS is scattered and piecemeal because researchers do not know what causes it. Currently, a very lucky accident in the research labs is our best bet.

  2. Charlie says:

    “In the new trial, patients will receive NP001 or a placebo for six months.”

    We should salute as heroes those who are put on a placebo and suffer continuous deterioration during the trial. A lot can go bad in 6 months.
    Anyways, they got to be in a trial. Most people don’t get the chance.

  3. Hopeful says:

    Speak with your Neurologist, they should be able to get you or loved one signed up for the trial. I will be talking to my Dad’s on the 27th.

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