Siponimod Reduces Risk of SPMS Patients’ Disability Worsening, Phase 3 Trial Shows

Siponimod Reduces Risk of SPMS Patients’ Disability Worsening, Phase 3 Trial Shows

Siponimod (BAF312) reduces the risk of disability progression in patients with secondary progressive multiple sclerosis (SPMS), a Phase 3 clinical trial shows.

An article about the Novartis therapy’s trial results appeared in the journal The Lancet. The title is “Siponimod versus placebo in secondary progressive multiple sclerosis (EXPAND): a double-blind, randomised, phase 3 study.”

The EXPAND trial (NCT01665144) covered 1,651 SPMS patients in 31 countries who were randomized to receive 2 mg of siponimod orally or a placebo once a day. The participants had moderate to severe disability, with scores on the Expanded Disability Status Scale (EDSS) ranging from 3.0 to 6.5

Siponimod reduced patients’ three-month disability progression scores by 21 percent and their six-month scores by 26 percent, compared with a placebo.

In addition, siponimod slowed patients’ brain shrinkage by 23 percent compared with a  placebo, and reduced by 55 percent patients’ annualized relapse rate after two years.

Another finding was that the therapy reduced by 80 percent the progression of brain lesions detected by imaging methods.

“These data are all the more impressive when considering that the majority of patients already had advanced disability when starting treatment in EXPAND,” Ludwig Kappos, a professor at University Hospital Basel in Switzerland, said in a press release. He was principal investigator of the trial.

Given the trial’s promising results, the company plans to submit a marketing application  for siponimod soon to the U.S. Food and Drug Administration. It would ask for its approval as a disease-modifying therapy for SPMS.

The company plans a filing with the European Medicines Agency in the third quarter of 2018.

“The pivotal EXPAND data provides patients, and the medical community alike, with hope that a much-needed, safe and effective treatment option is on the horizon for SPMS, for which treatment options are scarce,” said Danny Bar-Zohar, the global head of neuroscience development at Novartis. “We look forward to continuing to work with regulatory agencies to make siponimod available for these patients as fast as possible.”

Siponimod inhibits the activity of two sphingosine-1-phosphate receptors on the surface of immune cells, preventing the cells from traveling to the brain and spinal cord, where they can do damage. This means that siponimod reduces the inflammatory process that contributes to SPMS.

The EXPAND trial also showed that siponimod was safe, with patients who received it having a similar number of serious adverse events as the placebo patients.

Some adverse events were more frequent in siponimod-treated patients than in the placebo group, however. They included lower levels of immune cells in the blood, higher levels of liver enzymes, and slower heart rates, high blood pressure, and varicella infections.

10 comments

  1. VERBEKE DANIEL says:

    Dears,
    Any idea when SIPONIMOD will be available for application on the Belgian market ?
    Thanks for answer

  2. Adam says:

    I have been taking BAF 312 since 14 months, and unfortunately I didn’t find any positive effect. Walking is getting worse every day.

  3. marc stecker says:

    So, a 26% slowing down of disease progression. A modest benefit, at best. Did the researchers differentiate between patients with or without enhancing lesions? Probably not, as this would limit their chances for a wide FDA approval.

    It is absolutely pathetic that at this stage in the game this is what passes for a “dramatic” breakthrough. Enough with the semi-effective immunosuppressant drugs, let’s start focusing on neuroprotection and neuroregeneration. Would be nice if a few people started looking for the cure, also.

    Oh, wait, a cure would kill the cash cow that is MS.

    The current MS status quo is wonderful for all of those reaping billions of dollars from patients with a desperate, despicable disease, but should be totally unacceptable to the patient’s actually suffering from multiple sclerosis.

    • Bonnie says:

      So VERY true about the money Big Pharm
      makes!! Why find a
      cute?? No profit in
      that!!!!! Life,or not,
      goes on, or not for
      some of us!!!!

  4. Dave says:

    I would like to see our nation nip this ruthless disease in the gluteus maximus🙏 Godspeed everyone! Maybe if folks stop killing the innocent, Trump can work with Congress to figure a cure💥 Hope we will all see soon. Let us pray. Adios

  5. Ree says:

    As for me & my neurologist, we will do ANYTHING & EVERYTHING possible to get brain shrinkage under control & slow progression as much as we can. Hopefully by year end it will be available!!!! Looking forward to trying this!

  6. Dr.Paraminder says:

    Any idea when it will be available in the indian market and at what price. Should probably match the price of BG12.

  7. Patricia Wiegert says:

    Reading the other comments I can tell that my attitude isn’t too far off what others feel: fed up with the whole SPMS thing! Diagnosed in 1992 & still no drugs to slow things down or improve quality of life. The best I get is something to fight my fatigue & even that doesn’t do much good. My neuro told me back in 1992 that there was nothing and would be nothing but good luck to you! We SPMSers feel left behind, hopeless cause, not worth the effort since we’re too far along. Nasty!

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