News

Alkermes and Biogen have begun working together on a compound known as ALKS 8700 as a potential treatment for relapsing forms of multiple sclerosis. Under the agreement, Alkermes will be responsible for obtaining regulatory approval of the drug, while Biogen will handle its marketing. ALKS is taken orally. The body quickly transforms it into a compound known as monomethyl fumarate that can counter MS. Aikermes designed it to have better features than Tecfidera (dimethyl fumarate) — in particular, fewer gastrointestinal side effects. The partnership gives Biogen worldwide marketing rights to ALKS 8700. Alkermes will receive a royalty on global sales. Aikermes is evaluating ALKS 8700's safety and effectiveness in what it has dubbed the EVOLVE-MS clinical trial program. It includes two Phase 3 trials that are comparing ALKS 8700 with Tecfidera in patients with relapsing-remitting MS, or RRMS. Preliminary results of the EVOLVE-MS-1 trial, which involved 580 patients, showed few gastrointestinal side effects from ALKS 8700. The most common adverse events in the first month of treatment were flushing, diarrhea, and a rash known as pruritus. Aikermes discussed the treatments safety, and patients' ability to tolerate it, at the 7th Joint ECTRIMS-ACTRIMS Meeting in Paris in October. The company is still recruiting participants for a second trial that will compare ALKS 8700 and Tecfidera's effect on the gastrointestinal system. The EVOLVE-MS-2 study will  be conducted at locations in several U.S. states and six sites in Poland. Alkermes expects to release initial findings from the trial in the first half of 2018.  

Immune cells that destroy myelin in multiple sclerosis (MS) access the brain and spinal cord via two different routes, a new mouse study shows. This suggests that therapies which target these entry routes may shield the brains of MS patients from further damage. The study, “Caveolin1 Is Required for…

Mavenclad has become the multiple sclerosis therapy of choice for one in five neurologists in Germany and the United Kingdom, according to a Spherix Global Insights survey. Meanwhile, many European neurologists are looking forward to the continent's approval of Ocrevus, particularly as a treatment for primary progressive multiple sclerosis, or PPMS. The United States approved the therapy in March of 2017. European neurologists are using Mavenclad for both relapsing-remitting multiple sclerosis, or RRMS, and secondary progressive multiple sclerosis, SPMS. The report that Spherix issued on European neurologists' treatment choices is called "RealTime Dynamix: Multiple Sclerosis EU." It was based on a survey of 261 neurologists, who were asked about thei disease-modifying drugs they prescribed and the way they manage MS, according to a press release. The survey focused on Merck KGaA’s Mavenclad, which the European Union approved in August 2017, and Genentech’s Ocrevus, which the European Commission is expected to approve soon. The European Medicines Agency paved the way for approval by recommending its authorization earlier this month. Mavenclad is the first disease-modifying therapy that most of the patients who are on it have tried, according to the survey. Spherix analysts said this indicates that Mavenclad may expand the proportion of MS patients using disease-modifying drugs. But while Mavenclad’s label allows patients to use it as a first-line therapy, the survey revealed that many neurologists are not comfortable prescribing it as an initial treatment. This suggests that the Mavenclad-treated population may later include more patients who switched treatments, Spherix said. Mavenclad reduces MS relapses by resetting the immune system, studies have shown. Neurologists who prescribe it as a first-line treatment appear to endorse the idea of induction therapy. This approach involves more potent therapies being used from the onset of the disease. British neurologists in particular appear to favor the induction approach, the report revealed. Patients who had been on previous treatments have switched mainly from Copaxone (glatiramer acetate), interferons, or Novartis' Gilenya, the report showed. Many neurologists' lack of familiarity with Mavenclad may be limiting its use, the report said. It noted that two out of five neurologists had not received a detailed briefing on the drug, and more than one-third had not attended any launch activities. Limited market access was the second most common obstacle to Mavenclad prescription, the report indicated. Interestingly, those who had participated in Mavenclad launch activities said these consisted mostly of independent research or discussions with colleagues, rather than activities organized by Mavenclad’s developer Merck KGaA. Spherix’s survey was done just before the European Medicines Agency recommended Ocrevus' approval in mid-November. Even before the endorsement, the survey indicated, Ocrevus was by far the MS drug in development that most neurologists looked forward to using. The reasons, the neurologists said, were its beneficial effectiveness-safety profile, its new mechanism of action, the fact that it only needs to be given once every six months, and a treatment label that includes PPMS. It is the first disease-modifying drug ever approved for PPMS patients. Twice as many neurologists said they look forward to using Ocrevus as a first-line treatment for PPMS as those saying they wanted to use it as a first-line treatment for relapsing MS. And neurologists estimated that twice as many PPMS patients as RRMS patients are appropriate candidates for Ocrevus treatment. In a report in October about U.S. neurologists' treatment preferences, Spherix said those doctors estimated the number of PPMS Ocrevus candidates at three times that of RRMS patients. Nonetheless, about equally as many PPMS and RRMS patients had tried Ocrevus four months after its launch, the survey showed. The European situation may evolve in a similar manner, since the European Medicines Agency recommended a specific use of Ocrevus in PPMS patients. It specified that the drug be used in PPMS patients who show “imaging features characteristic of inflammatory activity." This makes it likely that only a subgroup of PPMS patients will receive the treatment. The use of Biogen's Tysabri, Gilenya, and Rituxan (rituximab), also made by Roche's Genentech subdivision, will be most impacted by Ocrevus' introduction. Despite this, neurologists believe rituximab's use will grow in the next six months, because Ocrevus is still not available, while lower-cost rituximab biosimilars are.

A diet rich in vegetables and low in protein reduced inflammation in multiple sclerosis (MS) patients by modulating the gut microbiome and promoting bacteria that helps control a hyper-reactive immune system. The study reporting the findings, “Immunological and Clinical Effect of Diet Modulation of the Gut…

So-called silent brain lesions in patients with early-stage relapsing-remitting multiple sclerosis (RRMS) may, in fact, not be silent at all, according to a French study that linked such lesions to cognitive decline in early MS. This link has likely been missed since the major tool for measuring disability in MS…

Smoking changes a DNA-based mechanism that influences multiple sclerosis patients’ gene activity, a Swedish study confirms. Another finding was that MS appears to aggravate the harmful effects of smoking. The study dealt with DNA methylation, the process by which the body adds methyl groups to a DNA molecule. Methylation can change…

Exposure to certain gut bacteria at a young age may cause multiple sclerosis (MS) and fuel its progression, a new mouse study shows. The study, “Gut dysbiosis breaks immunological tolerance toward the central nervous system during young adulthood,” appeared in the journal Proceedings of the National…

The National Organization for Rare Disorders (NORD) says it’s “disappointed and dismayed” after the House of Representatives voted 227-205 last week to repeal the Orphan Drug Tax Credit as part of a U.S. tax reform package. A similar package before the Senate Finance Committee does not repeal the credit…

Maryland special education teacher Ingrid Hanson says that since she was diagnosed with multiple sclerosis five years ago, she’s developed a better understanding of her students’ needs and the importance of teamwork. Flavia Nelson helps treat MS in the Hispanic community in Houston. Flavia Nelson, an MS specialist at…

Results of a Phase 1 clinical trial in healthy volunteers show that PTL101, an oral cannabidiol compound, is a safe and effectively delivered potential treatment of spasticity in multiple sclerosis (MS) and for conditions like epilepsy, Harvest One Cannabis announced. These findings were published in the journal Clinical Pharmacology in Drug Development, in the study…

An estimated 947,000 people in the U.S. have multiple sclerosis (MS) — more than double the long-accepted figure of 400,000 — according to a newly completed study organized and funded by the National Multiple Sclerosis Society (NMSS). “This is definitely not what we expected,”  Nicholas G. LaRocca, vice…

Available long-term data on Fampyra (fampridine; 4-aminopyridine) suggest the treatment may improve walking speed in patients with multiple sclerosis (MS) for up to one year, but more research is needed, a French study reports. The study “Multiple Sclerosis and Clinical Gait Analysis before and after Fampridine: A Systematic Review”…

U.S. nurses and physicians’ assistants prescribe antibody-based disease-modifying therapies to their multiple sclerosis patients more than neurologists do, a survey indicates. The trend has been for the doctors to stick with interferon therapies, the study said. Antibody-based disease-modifying therapies are also known as monoclonal antibodies. They are designed to harness the…

Multiple sclerosis (MS) patients being treated with dronabinol, a cannabinoid, do not show signs of drug abuse or dependency, leading researchers to conclude it has potential to be a long-term and safe treatment option for neuropathic pain. The issue of pain management, specifically central neuropathic pain (CNP), in patients with autoimmune disorders…

A pregnancy hormone called estriol may be effective in controlling relapses in women with multiple sclerosis (MS), says a researcher at the University of California, Los Angeles (UCLA). In clinical trials, estriol has also lowered fatigue and improved thinking — work that originated in Rhonda Voskuhl’s quest to understand…

Celgene released the results of two Phase 3 trials showing that patients with relapsing multiple sclerosis (MS) who were treated with ozanimod had lower relapse rates and fewer MRI brain lesions compared to those given a current first-line therapy, Avonex (interferon β-1a). These results will be used to support a request…

A physiotherapist-supported exercise program using Nintendo Wii may be a feasible and cost-effective way of helping  people with multiple sclerosis (MS) be more physically active, researchers reported after performing a small pilot study. While findings showed some evidence that people improved — both in terms of self-reported health, gait and balance measurements — researchers underscored that more data needs to be gathered on the intervention’s effectiveness, as the study mainly intended to determine if such a program was feasible. Researchers at the Bournemouth University and Poole Hospital NHS Foundation Trust, both in the U.K., argued that a physical activity intervention using active gaming at home may overcome the many challenges MS patients face when attempting to be active. Barriers to it could be physical, but psychological factors, such as fear, embarrassment, or lack of confidence, can also prevent patients from attempting to increase their activity levels. Moreover, practical aspects — such as transport and cost — can hinder people from joining interventions. In the report, “Mii-vitaliSe: a pilot randomised controlled trial of a home gaming system (Nintendo Wii) to increase activity levels, vitality and well-being in people with multiple sclerosis,” researchers explained they used data generated in earlier Nintendo Wii studies to design an improved intervention program. Earlier studies showed that behavior change techniques, including motivational interviews and problem solving, would likely improve the impact of an intervention. These early studies also highlighted the importance of considering the functional levels, environment, and preferences of individual patients when prescribing a Wii-based program. The study (ISRCTN49286846), described in the journal BMJ Open, shows that among the 30 people who signed up, only two dropped out because of medical reasons. Patients either received the 12-month intervention, called Mii-vitaliSe, directly or after a six-month waiting period. Those on the waiting list group were given six months of intervention. Patients, who had low levels of physical activity when the study began, were instructed as to the benefits of physical activity and on how to use the Wii. During the personalized intervention, participants had access to regular support from a physiotherapist and were provided with a personal activity workbook, which aided participants in setting goals and monitoring progress, among other things. They were also asked to keep a log to track their activity, which showed an average use of the Wii two times per week, for 27 minutes each day. Results showed that patients who started the intervention immediately tended to report better physical activity levels, and better physical and psychological well-being. They also had numerical improvements in gait and balance. While no severe adverse reactions were seen, participants reported pain and worsening of scar tissue after some exercises, for which they received follow-up advice and care. The team also identified several problems or difficulties, including wrongly completed questionnaires, that will allow them to improve measurements once they launch a larger study. "Our study is the first to report on home-based use of the Wii for people with MS in the UK. Overall, findings from this study are promising and support proceeding to a full-scale trial of effectiveness and cost-effectiveness. We will refine the trial design, aspects of the intervention and finalize outcome measures in the light of our experiences from this pilot study" the researchers wrote.

Europeans with relapsing multiple sclerosis (MS) and early primary progressive MS are one step closer to accessing Ocrevus, now that the European Medicines Agency has urged the European Union to approve the therapy. The positive opinion — announced in a press release issued Nov. 10 by the EMA’s Committee for Medicinal Products for Human Use — is an intermediary step required in the regulatory pathway to allow patient access to a new drug. The European Commission will now make a final decision on whether Ocrevus should be granted marketing authorization in all 28 EU member states. This decision will take the CHMP recommendation into consideration. If approved, Ocrevus will become the first disease-modifying medicine available throughout Europe for patients with PPMS. Once this happens, any decisions on price or insurance reimbursements will be the responsibility of each member state. Ocrevus won U.S. approval earlier this year. It was also recently approved in Switzerland for both relapsing MS and PPMS. Ocrevus is an anti-CD20 antibody developed by Genentech, a division of Roche. It blocks immune B-cells, preventing them from attacking nerve cells and their myelin protective sheath, as well as inhibiting other pro-inflammatory immune signals involved in MS. CHMP based its positive recommendation on data from three pivotal Phase 3 clinical trials: the OPERA I and II trials in relapsing MS patients, and the ORATORIO trial in PPMS patients. Results from the OPERA clinical studies demonstrated that treatment with Ocrevus for up to 96 weeks could reduce the annualized relapse rate by 46.4 percent compared with EMD Serono’s approved drug Rebif (interferon beta-1a) in relapsing MS patients. The ORATORIO trial showed that Ocrevus could reduce by 24 percent the risk of 12-week confirmed disability progression compared to placebo in PPMS patients. Data from the trial further supported the drug's therapeutic benefit in early-stage PPMS patients. Additional studies are warranted to better evaluate the therapeutic potential of Ocrevus for patients with more advanced stages of the disease. The most common treatment-associated adverse effects reported wee infusion-related reactions and infections.

MMJ BioScience, an affiliate of medical cannabis research company MMJ International Holdings, has hired a principal investigator to lead clinical trials exploring potential therapeutic applications of cannabinoids in progressive multiple sclerosis (MS). Dr. Bianca Weinstock-Guttman, a neurology professor at the State University of New York at Buffalo, is executive director…

Merck’s Mavenclad (cladribine tablets) is now a recommended treatment for British adults with highly active multiple sclerosis (MS), following the issuance of a final appraisal determination by the country’s National Institute for Health and Clinical Excellence (NICE). The therapy — given at a dosage of 10 mg — received the…

Sanofi Genzyme and Principia Biopharma have entered into a license agreement to advance the clinical development of PRN2246, an oral drug candidate for the treatment of multiple sclerosis and other diseases of the central nervous system. PRN2246 is an inhibitor of the Bruton’s tyrosine kinase, an enzyme encoded by the BTK gene that plays a crucial role in B-cell development and the B-cell signaling pathway. B-cells are known to be involved in the development of autoimmune diseases that affect the nervous system, including multiple sclerosis. PRN2246 is an orally available therapy designed to easily access the central nervous system (brain and spinal cord) by crossing the blood-brain barrier, and impact the signaling of immune cells and brain cells involved in autoimmunity and inflammatory processes. The drug is designed to safely and effectively modulate B-cell function without depleting these cells. A Phase 1 clinical trial is now testing the drug's safety in healthy volunteers. Under the agreement, which is expected to close shortly, Principia will grant Sanofi an exclusive, worldwide license to develop and commercialize PRN2246. Principia, in return, will receive $40 million in upfront payments from Sanofi, and future milestone payments could reach $765 million. Principia will retain the option to co-fund the treatment's Phase 3 development in exchange for other royalties in the United States. Principia has developed a novel way to design and develop better and safer therapies based on oral small molecules. The company uses its proprietary Tailored Covalency technology to develop its drug candidates, which are, according to the company's website, safer, and more selective, potent and durable than other available treatments. The terms of this licensing agreement are still subject to customary regulatory approval.

A national survey in the U.S. revealed that 98% of women newly diagnosed with multiple sclerosis struggle to discuss important personal concerns with their healthcare team.

Longevity Biotech has received a $316,384 grant from the National MS Society to see if LBT-3627, the nerve cell-protecting therapy it has tested in Parkinson’s, can work in multiple sclerosis as well. The company designed the therapy to protect and repair damaged nerve cells and restore balance to the out-of-whack immune response associated…

The CXCR7 receptor present on mature monocytes — a type of white blood cell — may be a therapeutic target to alleviate the inflammation seen in multiple sclerosis (MS) and similar disorders, a new study shows. The study, “Frontline Science: CXCR7 mediates CD14+CD16+ monocyte transmigration across the blood…

Actelion is recruiting about 600 relapsing multiple sclerosis (MS) patients to a Phase 3 trial testing the addition of oral ponesimod to Tecfidera (dimethyl fumarate) in people who continue experiencing relapses while on the treatment. Ponesimod works in a similar way to Novartis’ Gilenya (fingolimod) — making immune…

A blood-clotting protein called fibrinogen prevents myelin production and blocks the neuron remyelination repair process in mice, a study finds. The study, “Fibrinogen Activates BMP Signaling in Oligodendrocyte Progenitor Cells and Inhibits Remyelination after Vascular Damage,” appeared in the journal Neuron. Its conclusions offer new insights and…

In the future, a blood test may make diagnosing multiple sclerosis (MS) much easier, thanks to newly identified biomarker patterns that distinguish between MS patients and healthy people. The test could also correctly detect primary progressive MS (PPMS) in patients who also had relapsing-remitting disease (RRMS). Australian researchers suggest that…

The National Multiple Sclerosis Society (NMSS) has officially announced its collaboration with Corrona on the launch of the Corrona Multiple Sclerosis Registry to compare the safety and effectiveness of approved therapies in multiple sclerosis (MS). Corrona, based in Cambridge, Massachusetts, conducts observational cohort studies, offering analytic expertise…

The generation of a thin myelin sheath during remyelination — one that continues to protect nerve cells over time — is indicative of the long-term health and activity of the central nervous system (CNS) in demyelinating diseases such as multiple sclerosis (MS), a new study shows. These findings, which aim…

Research teams from Canada, Portugal and the United States, each with projects focused on predicting and defining characteristics of multiple sclerosis (MS) , will share this year’s 1 million euro ($1,165,700) Grant for Multiple Sclerosis Innovation (GMSI), announced by Merck at the 7th Joint ECTRIMS-ACTRIMS meeting in Paris, France,…