Blog | February 18, 2015

Who Is Forging Ahead In The MS Treatment Space?

By Anna Rose Welch, Editorial & Community Director, Advancing RNA

MS

The NIH estimates roughly $103 million of its budget will be spent on multiple sclerosis research in 2015. That seems like a small amount of money when it comes to the size of its $40 billion budget.  But in doing some digging around, I’m seeing signs that there are actually quite a few players — big and small — in the academic, bio, and pharma realms working in the MS treatment space to benefit the 400,000 U.S. and 2.3 million patients globally.  

The treatment space for MS is currently populated by some big names. These include Biogen Idec’s quartet: Avonex, Tsyabri, Tecfidera, and Plegridy. There’s also Teva’s Copaxone, Novartis’ Gilenya, Merck KGaA’s Rebif, and Sanofi’s Aubagio and Lemtrada. 

But where does the industry stand in terms of finding new, innovative treatment options for the disease? Here are some of the recent efforts I’ve stumbled upon as of late:

  • First, we have Acorda’s rHlgM22. Just a few weeks ago, the treatment, which is indicated to cause remyelination in MS, cleared a Phase 1 safety trial. It’s too early to know if the drug will come to fruition in future trials. For now, the study is still being designed and the drug will enter into another Phase 1 study in relapsing MS patients to determine if there are any disconcerting interactions.
  • Researchers in Dublin have found that an arthritis drug, MCC950, could be used to fight MS. In tests on mice, the drug “instantly blocked” MS, says Irish Central. (As a side note, it sounds like there’s a lot of good happening with biopharma innovation in Ireland these days, according to a recent Life Science Leader column.)
  • Biogen recently released some results from its RENEW trial, which investigated the drug’s impact on patients with acute optic neuritis, one of the first symptoms of MS. However, results were…tricky, to say the least. The company lauded the results as “positive.” However, some in the industry are approaching the news with skepticism. While there was a 34 percent improvement in optic nerve latency (the trial’s primary endpoint), eyesight improvement was not measured, nor did the drug repair any damaged retinal nerve cells, according to Xconomy. The company is also holding a larger Phase 2 trial, known as SYNERGY, which has enrolled 400 MS patients.   
  • GSK has a candidate under investigation for remyelination, known as GSK239512, that completed  Phase 2 trials back in September. However, the company has remained relatively close-lipped about it; results have yet to be revealed since the trial concluded. In taking a peak at the company’s pipeline though, it looks like the company is also investigating the subcutaneous administration of ofatumumab in phase 2 trials for relapsing-remitting MS, after reporting a Phase 2 success for the candidate in MS back in January 2014.
  • Biogen and AbbVie have teamed up to work on a new monthly MS treatment, daclizumab. The drug proved itself in a Phase 3 trial by reducing patients’ relapse rates, trumping Biogen’s Avonex by 45 percent in the process. It also reduced lesions and risk of disease progression, and left patients relapse-free for 96 weeks. The companies hope to file for FDA/EU approval in the months ahead, which could add another big player to Biogen’s already-large MS portfolio.
  • Alkermes entered its ALKS 8700 into a Phase 1 trial in July and recently announced that its safety profile was comparable to that of Biogen’s Tecfidera — good news for Alkermes as it aims to eventually tackle some of the market share for blockbuster Tecfidera. The drug is an oral prodrug containing the active ingredient monomethyl fumarate, which is broken down once swallowed.
  • Teva has a couple of ongoing trials for laquinimod for relapsing-remitting MS, as well as several for its $4.2 billion blockbuster Copaxone, which is soon facing a patent expiration that’s probably making Teva a little nervous.

We might end up seeing more from Novartis besides Gilenya in the future as well. According to the company’s website, it has plans to enter its BAF312 in MS into trials sometime before 2019.

While all these players have potential drug candidates in the works, a couple of other sources I’ve come across suggest stem cell transplants could be a promising form of treatment. According to The Motley Fool, hematopoietic stem cell transplantation (HSCT) led to substantial improvements in some patients’ quality of life, and it improved cognitive function and reduced the volume of brain lesions in a trial held at Northwestern University.

Similarly, in Winnipeg, Canada, researchers are exploring the possibility that the MS patient’s bone marrow stem cells could be the key to treatment. Indeed, a new study published in Neurology has found that bone marrow stem cell transplants were a more beneficial treatment for resetting the immune system in patients with severe MS than the drug mitoxantrone.