Adamas Stopping Further Work on ADS-5102 for Walking Problems in MS

Adamas Stopping Further Work on ADS-5102 for Walking Problems in MS
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Adamas Pharmaceuticals has decided to stop further clinical development of ADS-5102 (amantadine), intended to help people with multiple sclerosis (MS) who have difficulties with walking.

The decision came after the company reviewed findings from a comprehensive analysis of its Phase 3 INROADS trial (NCT03436199), which assessed the safety and efficacy of ADS-5102 in 594 MS patients with walking impairments.

According to the company, this analysis was in agreement with top-line study data announced last year, showing an improvement in walking speeds of about 20% in those randomized to daily ADS-5102, an extended release capsule treatment, compared with placebo. But these gains were of low magnitude, rather than the degree anticipated.

These findings, in turn, necessitated a reconsideration of the treatment’s likely profile if approved, which — based on feedback from patients and physicians —  “projected a limited commercial opportunity,” Adamas stated in a press release.

Discussions with the U.S. Food and Drug Administration (FDA) also confirmed that an additional Phase 3 trial would be required to support an application requesting ADS-5102’s approval in MS.

Despite choosing not to pursue further studies, Adamas said it will complete INROADS’ open-label extension trial (NCT03567057), due to end in January 2021.  Here, all who finished the original study are being treated with ADS-5102 capsules for up to one year.

“As a patient focused company this was a difficult decision, and I want to thank the patients, healthcare professionals, and employees who contributed to this development program. There remains a significant unmet need for this population and we are committed to completing the open-label study and publishing our data to benefit the MS community,” Neil F. McFarlane, the company’s CEO, said in the release.

Under the brand name Gocovri, ADS-5102 was approved by the FDA to treat involuntary muscle twitching (dyskinesia) in people with Parkinson’s disease on levodopa-based therapies in 2017.

An extended-release capsule taken before bedtime, Gocovri is the only medication to date shown to reduce both dyskinesia and the duration of “off periods” — times during which levodopa-based treatments cease to be effective at keeping the motor symptoms of Parkinson’s at bay — rather than requiring a trade-off between these two treatment goals.

In June, Adamas submitted a supplemental new drug application to the FDA, asking that Gocovri also be approved as an off episodes treatment for Parkinson’s patients using levodopa.

Joana holds a BSc in Biology, a MSc in Evolutionary and Developmental Biology and a PhD in Biomedical Sciences from Universidade de Lisboa, Portugal. Her work has been focused on the impact of non-canonical Wnt signaling in the collective behavior of endothelial cells — cells that made up the lining of blood vessels — found in the umbilical cord of newborns.
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Patrícia holds her PhD in Medical Microbiology and Infectious Diseases from the Leiden University Medical Center in Leiden, The Netherlands. She has studied Applied Biology at Universidade do Minho and was a postdoctoral research fellow at Instituto de Medicina Molecular in Lisbon, Portugal. Her work has been focused on molecular genetic traits of infectious agents such as viruses and parasites.
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Joana holds a BSc in Biology, a MSc in Evolutionary and Developmental Biology and a PhD in Biomedical Sciences from Universidade de Lisboa, Portugal. Her work has been focused on the impact of non-canonical Wnt signaling in the collective behavior of endothelial cells — cells that made up the lining of blood vessels — found in the umbilical cord of newborns.
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