STOP 301 Trial of INP104 Initiated, Suvodirsen Gets Fast Track Designation, Siponimod EXPAND Data
Neurology News Network for the week ending September 21, 2019.
PUBLISHED September 21, 2019
This week, Neurology News Network covered Impel NeuroPharma’s nasal DHE agent, INP104, and the launch of its phase 3 STOP 301 trial; Wave Life Science’s investigational stereopure oligonucleotide suvodirsen receiving FDA fast track designation; and a new analysis of the EXPAND study population treated with siponimod (transcript below).
Alicia: Welcome to Neurology News Network. I’m Alicia Bigica.Let’s get into the news from this week.
New data presented at the 19th Congress of the International Headache Society on Impel NeuroPharma’s nasal DHE agent support the launch of its phase 3 STOP 301 trial, which will assess the safety and efficacy of INP104, a nasal DHE administered via the precision olfactory delivery device, for the treatment of acute migraine. The novel delivery system is intended to deliver a reduced dose of DHE to the upper nasal cavity that may be both more effective and more tolerable than current formulations on the market. The study, which has an estimated enrollment of 300 patients, will also assess the effect of the treatment on quality of life and health care utilization.
The FDA has granted Wave Life Science’s investigational stereopure oligonucleotide suvodirsen fast track designation for the treatment of Duchenne muscular dystrophy in patients amenable to exon 51 skipping. The drug, which is currently being studied in a global phase 2/3 multicenter study and an open-label extension, had previously been granted orphan drug status and rare pediatric disease designation by the FDA.
Findings from a new analysis of the EXPAND study population suggest that siponimod may have an additional long-term benefit for patients with secondary progressive MS. Results showd that siponimod, marketed as Mayzent, delayed the median time to wheelchair by 4.3 years in the overall population compared to placebo, aligning with previous findings that treatment with the drug reduces disability progression.
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