Ponesimod hits key endpoints in clinical trial for relapsing multiple sclerosis: industry news round-up

Written by Sharon Salt, Editor

This week, we’re covering some of the latest industry headlines on ponesimod for relapsing multiple sclerosis, the Accordion Pill® for Parkinson’s disease and cannabidiol oral solution for seizures. Discover more about our selection of this week’s highlights below:


Cannabinoid-derived drug (Epidyolex™) gains positive CHMP opinion for seizures

GW Pharmaceuticals (CA, USA) has received a positive opinion for Epidyolex™ (cannabidiol) for its use as an adjunctive therapy alongside clobazam for seizures associated with Lennox–Gastaut syndrome (LGS), or Dravet syndrome, in patients 2 years of age and older.

“Cannabidiol oral solution is the first in a new class of epilepsy medicines and the first plant-derived cannabis-based medicine to be submitted for European regulatory review, representing a historic breakthrough,” commented Justin Gover, the Chief Executive Officer at GW Pharmaceuticals.

This positive opinion is based on results from four randomized controlled Phase III studies, which incorporates data from more than 714 people with either LGS or Dravet syndrome.

GW Pharmaceuticals’ cannabidiol oral solution has previously been approved by the US FDA in June 2018 under the trade name Epidiolex®.

Source: http://ir.gwpharm.com/news-releases/news-release-details/gw-pharmaceuticals-receives-positive-chmp-opinion-epidyolextm

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Ponesimod hits key endpoints for Phase III trial in adults with relapsing multiple sclerosis

Positive top-line results from the Phase III OPTIMUM study, which evaluated the safety and efficacy of ponesimod compared with Aubagio® (teriflunomide), have been announced for adults with relapsing multiple sclerosis. Janssen (NJ, USA) reported that the study met its primary endpoints and most of its secondary endpoints.

OPTIMUM was a head-to-head, prospective, multicenter, randomized, double-blind, active controlled, parallel group Phase III study that included 1133 participants with a treatment duration of 108 weeks (ponesimod 20 mg and teriflunomide 14 mg).

The primary endpoint of OPTIMUM was annualized relapse ratio up to the end of the study. Additionally, a key secondary endpoint included the change from baseline to week 108 in fatigue-related symptoms.

Results from the trial will be presented at the 35th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) 2019 (11–13 September, Stockholm, Sweden). This data will also serve as a basis of submission to the US FDA.

Source: www.jnj.com/janssen-reports-positive-top-line-phase-3-results-for-ponesimod-in-adults-with-relapsing-multiple-sclerosis

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Accordion Pill® fails to achieve statistical superiority to Sinemet® for Parkinson’s disease

Results from ACCORDANCE, a Phase III clinical trial evaluating the safety and efficacy of the Accordion Pill®-carbidopa/levodopa (AP-CD/LD) compared with immediate release CD/LD (Sinemet®) as a treatment for the symptoms of advanced Parkinson’s disease, have been revealed by Intec Pharma (Jerusalem, Israel).

The company announced that AP-CD/LD did not demonstrate a statistically significant reduction in OFF time over that obtained with Sinemet. In addition to this, treatment-emergent adverse effects observed with AP-CD/LD were generally consistent with the known safety profile of CD/LD formulations and no new safety issues were observed through the open-label extension study.

Jeffrey Meckler, Vice Chairmen of Intec Pharma, concluded: “While the data suggests that the AP CD/LD did achieve an acceptable safety profile and did treat Parkinson’s disease symptoms, it did not achieve a statistically significant superiority to standard immediate release levodopa therapy. We are pleased with the good safety profile of the AP-CD/LD, as it demonstrates for the first time the long-term safety of the Accordion Pill, which is important for future potential applications and partnerships.”

Source: https://ir.intecpharma.com/news-releases/news-release-details/intec-pharma-reports-top-line-phase-3-trial-results-accordion

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