clinical trials

Sweden's Active Biotech said its experimental therapy Laquinimod failed to meet the primary and secondary objectives of Phase 2 clinical trial evaluating the drug's potential to treat primary progressive multiple sclerosis. Laquinimod, also known as Nerventra or ABR-215062, was developed by Active Biotech and Israel's Teva Pharmaceutical Industries. The drug targets inflammation and degeneration in neurological tissue. Preclinical studies using animal models of multiple sclerosis showed that laquinimod regulated inflammatory and immune responses in these animals, reducing disease progression. The ARPEGGIO Phase 2 study aimed to evaluate laquinimod's efficacy, safety and tolerability in PPMS patients. Its primary endpoint was brain atrophy as defined by percent brain volume change. Secondary goals included time to disability progression, change in timed 25-foot walk, and number of new T2 lesions. The multicenter, randomized, double-blind, placebo-controlled trial enrolled 374 individuals. Initially, the study aimed to evaluate two doses of laquinimod — 0.6 and 1.5 mg/day — in PPMS compared to placebo. However, the highest dose was discontinued in January 2016 after some participants reported adverse cardiovascular events. In a Dec. 1 press release, Active Biotech said the lower dose of laquinimod failed to slow both the rate of brain atrophy and disease progression. “There was, however, a reduction in new T2 lesions observed in patients treated with laquinimod 0.6 mg,” said the company's president and CEO, Helén Tuvesson. The trial revealed a similar safety profile to that observed in previous studies in relapsing-remitting MS patients (RRMS). The most common adverse reactions were headache, nasopharyngities, upper respiratory tract infection,and back pain. Results of the ARPEGGIO trial will likely be presented at a future scientific conference and published in a scientific journal. Earlier this year, Active Biotec stopped developing laquinimod as a potential RRMS treatment after a Phase 3 study failed to achieve its primary goal: slowing disease progression. Laquinimod is also being evaluated as a potential therapy for Huntington’s disease in a Phase 2 clinical trial.

Oral steroids may be cheaper, more convenient and less invasive alternatives than intravenous steroids in treating relapses in multiple sclerosis (MS) patients, suggests an analysis of five randomized trials. Glucocorticoids are recommended as the first line of treatment for MS relapses. Yet recent studies have shown no significant difference between…

Flex Pharma has completed enrolling multiple sclerosis patients in a Phase 2 clinical trial in Australia testing FLX-787’s ability to alleviate muscle stiffness, spasms, and cramps. The compound has a mechanism of action that Flex believe will generate fewer side effects than other muscle-relaxing medications. The company is also…

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…

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…

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…

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…

Preliminary data from the Phase 3 EVOLVE-MS-1 trial shows that ALKS 8700 — an investigative therapy developed by Alkermes to treat relapsing forms of multiple sclerosis — has a good safety and tolerability profile. ALKS 8700 is an oral compound. Once inside the body, it is rapidly transformed into the therapeutic compound monomethyl fumarate (MMF). Although similar, this drug candidate was designed to offer features different than those achieved with the commercially available Tecfidera (dimethyl fumarate). Alkermes is currently assessing the safety and efficacy of ALKS 8700 in the EVOLVE-MS program, which includes two Phase 3 clinical trials in patients with relapsing-remitting MS. The EVOLVE-MS-1 is a two-year study being conducted in 107 U.S. and European research sites. It will evaluate the long-term safety of ALKS 8700 in some 930 RRMS patients. Interim data collected during the first month of treating 580 participants showed low incidence of GI adverse events, with no reports of serious events. The most common adverse side effects associated with the treatment were flushing, pruritus and diarrhea. Alkermes, which is based in Ireland, said additional results from the initial three months of treatment further supported the positive safety data of ALKS 8700, with only 2.3 percent of patients reporting serious adverse events and 3.7 percent having to stop treatment. The EVOLVE-MS-2 trial, being conducted at 48 U.S. sites, will compare the safety and efficacy of ALKS 8700 versus Tecfidera in RRMS patients. The study is still recruiting participants. Recent data of EVOLVE-MS-2 was also subject of a poster presentation at the ECTRIMS-ACTRIMS Meeting.

Potential new ways of capturing disease progression in multiple sclerosis (MS) patients — including those with chronic as opposed to active inflammation — are coming to the fore as analyses continue into the huge amounts of data collected during pivotal clinical trials that led to Ocrevus’ approval, a leading Genentech researcher…

Celgene‘s investigative drug ozanimod has been shown to be more efficient than an intramuscular injection of interferon beta-1a (marketed as Avonex by Biogen) in reducing relapses and disease progression in patients with relapsing multiple sclerosis (MS), according to results of the two-year Phase 3 RADIANCE trial. The findings were…

GeNeuro‘s humanized antibody GNbAC1 promotes the rejuvenation of the myelin coating that protects nerve cells in patients with relapsing-remitting multiple sclerosis, or RRMS, a Phase 2 clinical trial shows. The treatment is also safe, the study showed. Dr. Hans-Peter Hartung of the Heinrich-Heine-University Düsseldorf in Germany presented the results at the 7th…

The Japanese company MediciNova‘s anti-inflammatory agent ibudilast slows multiple sclerosis patients’ brain shrinkage and their loss of the protective myelin coating around nerve cells, a Phase 2 clinical trial shows. Robert J. Fox of Ohio’s Cleveland Clinic Neurological Institute presented the results at the 7th Joint ECTRIMS-ACTRIMS Meeting in Paris, Oct. 25-28.

Gilenya (fingolimod) was seen to significantly reduce relapses in children and teenagers with multiple sclerosis (MS), according to data from a Phase 3 study — the first successfully conducted in pediatric patients. Novartis, the therapy’s developer, is preparing to file requests for Gilenya to be approved to…

A clinical study now enrolling people with progressive or relapsing multiple sclerosis (MS) will examine the feasibility of older patients stopping use of disease-modifying therapies if they have had no relapses for a number of years. John Corboy, with the University of Colorado School of Medicine, presented the study at…

Ozanimod (RPC1063) was seen to lower relapse rates and reduce brain and spinal cord lesions among patients with relapsing multiple sclerosis (MS) participating in a Phase 3 study of the treatment. Giancarlo Comi, from the Vita-Salute San Raffaele University, in Italy, announced the results in a presentation during the ongoing…

This is a special edition of Multiple Sclerosis News Today's daily Alexa Flash Briefing, covering the latest news from the 7th Joint ECTRIMS-ACTRIMS Meeting currently underway in Paris, France. The MS News today team in on-site at the conference, providing exclusive coverage of the presentations and speakers.

Genentech’s Ocrevus (ocrelizumab) improved the vision of people with relapsing multiple sclerosis better than the widely used therapy interferon beta-1a, according to clinical trial findings presented at the 7th Joint ECTRIMS-ACTRIMS Meeting in Paris. Dr. Laura Balcer of the department of neurology at New York University made the presentation, titled “Effect…

While Tysabri (natalizumab) failed to slow worsening disability in people with secondary progressive multiple sclerosis (SPMS) in a Phase 3 trial, researchers now suggest that the treatment did improve walking and arm function in people with advanced disability. Researchers presented new analyses of data from the ASCEND trial (…

MD1003, a high-dose biotin developed by MedDay, slowed or prevented further disease progression among progressive multiple sclerosis (MS) patients in a Phase 3 clinical trial, researchers announced at the Oct. 25–28 7th Joint ECTRIMS-ACTRIMS Meeting in Paris, France. The effects of the treatment were seen to be upheld over…

Novartis’ Siponimod led to a dramatic drop in the number of inflammation patches in the brains and spinal cords of secondary progressive multiple sclerosis patients, according to a Phase 3 clinical trial. Robert Fox of the Cleveland Clinic’s Mellen Center for Treatment and Research in Multiple Sclerosis presented the findings…

Opicinumab, an investigative treatment aiming to promote remyelination in relapsing multiple sclerosis (MS) patients, will be tested in a new clinical trial —  having failed at an earlier effort, but having shown promise enough in particular patients to be worth a closer look. In fact, the new AFFINITY study “is…

Atara Biotherapeutics has started a Phase 1 clinical trial to assess ATA188’s safety and potential to treat progressive or relapsing-remitting multiple sclerosis. ATA188 is the company’s next-generation T-cell immunotherapy. It targets Epstein-Barr virus antigens that play an important role in the development of MS. An antigen is a molecule capable of…

Alkermes will showcase its work in developing a treatment that harnesses the effect of Tecfidera (dimethyl fumarate) for relapsing multiple sclerosis (MS), while lowering the risk of stomach problems at the 7th Joint ECTRIMS-ACTRIMS Meeting this month in Paris. The investigational drug, ALKS 8700, uses the same mechanism of action as Tecfidera. By building the molecule in a different way, however, the company expects it will show better tolerability. Once in the body, dimethyl fumarate turns into monomethyl fumarate (MMF), the molecule that actually impacts MS disease processes. But before giving rise to MMF, dimethyl can cause side effects in users, particularly gastrointestinal. In fact, stomach problem were what caused people in Tecfidera Phase 3 trials to stop the treatment. Alkermes uses a so-called prodrug approach to try to overcome this problem. By attaching a different compound to MMF — which breaks away from the molecule once in the body —  it is possible to deliver MMF with lesser gastrointestinal side effects, Phase 1 study data indicate. At the meeting, the company will present two posters on two clinical trials exploring ALKS 8700 in patients with relapsing-remitting MS. The first presentation, will describe a Phase 3 trial that aims to compare ALKS 8700 to Tecfidera in about 420 patients. The trial is primarily concerned with the drug’s safety, and will measure the occurrence and impact of gastrointestinal side effects in the two treatment groups. The presentation will only include descriptions of patients characteristics and study design, as outcomes are yet to be analyzed. Patients who complete the Phase 3 trial will be eligible to continue in an ongoing open-label, long-term safety study, called EVOLVE-MS-1, covered in the company’s second presentation. By March 3, 2017, the study had enrolled 543 patients. In addition to describing patient characteristics, researchers will present the rates of discontinuation caused by gastrointestinal adverse events within one month of starting the treatment.

TG Therapeutics’ ublituximab nearly eradicated a type of immune B-cell believed to be involved in multiple sclerosis, according to a Phase 2 clinical trial. The result was that none of the patients had a relapse during the first six months of the trial, which is continuing, researchers said. In addition, ublituximab reduced the brain and spinal cord lesions of the relapsing MS patients involved in the trial and prevented new ones from forming. The company will present the interim trial results in three poster presentations at the 7th Joint ECTRIMS-ACTRIMS Meeting in Paris, Oct. 25-28. Meanwhile, researchers will continue to study the effectiveness of ublituximab, a B-cell-depleting antibody, versus a placebo, for another six months. The trial is being held at several U.S. medical facilities. Participants receive two initial infusions of ublituximab or a placebo on day 1 and 15 during the first 28 days. After this initial period, those in the placebo-group are also given ublituximab and followed for 52 weeks. A key trial finding was that over the initial 24 weeks of the trial, the treatment nearly wiped out a type of B-cell known as CD20 that scientists believe is involved in the development of MS. Only 1 percent of the B-cells remained after a month. While helpful immune T-cell numbers dropped slightly after the first ublituximab infusion, they bounced back quickly. Researchers also reported a reduction in patients' magnetic resonance imaging (MRI) lesions, with no new inflammatory lesions appearing during the six months. So far, none of the trial participants has had a serious adverse event. Most of the adverse events were mild or moderate and related to the infusions. The trial also demonstrated that speeding up infusions did not increase infusion-related reactions. The speed-up results indicated that — if proven effective and safe — ublituximab will be more convenient for patients than B-cell-depleting drugs that require infusions stretching over several hours.

BC Platforms announced that Biogen and the Accelerated Cure Project (ACP) will use its platform to advance research in multiple sclerosis (MS) by bringing data collected through clinical trials, biobanks and the like directly to researchers and other experts in the field. Microsoft is also a project partner,…

Scientists have been trying to find a way to restore a protective covering around nerve cells whose loss leads to the neuron damage associated with multiple sclerosis. A team at the University of California, San Francisco may have found a way to do it. And perhaps surprisingly, the possible solution…

Lemtrada Prevented Progression of Multiple Sclerosis for Five Years, Study Shows Full disclosure: I’m being treated with Lemtrada, so any news about it lights up my radar like a Christmas tree. I’m 10 months post-round 1 and am doing well — and this news looks like it’s…

Antisense Therapeutics announced that it is proceeding with a Phase 2b clinical trial of ATL1102, its lead candidate to treat multiple sclerosis, after the U.S. Food and Drug Administration (FDA) lifted a clinical hold it had placed on the company’s request — in the form of a trial application or IND —…

Researchers at the University of Nottingham and neurologists at Nottingham University Hospitals NHS Trust in England will be working with a team from the Cleveland Clinic in Ohio to better understand the best therapeutic strategy for multiple sclerosis (MS) patients. The $10.6 million international clinical trial was one of five…