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Exciting News from Xenon Pharmaceuticals for the SCN8A Community!

7/5/2019

2 Comments

 
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TCSF Founder and Director, Hillary Savoie, with Xenon's VP of Biology, JP Johnson Jr, at Xenon during her visit in April 2019.
Last week, Xenon announced that they had received positive feedback from the FDA regarding the development of XEN901 that supported advancing XEN901 directly into a pediatric clinical trial examining its efficacy in pediatric patients with SCN8A epileptic encephalopathy (SCN8A-EE). This is important as most Anti-Epileptic Drugs (AEDs) have to be studied in adults before they are studied in pediatric populations.
Xenon is currently in the process of completing development of a pediatric-friendly formulation of XEN901 to support the study that will be compatible with feeding tubes. They will test the new formulation in healthy adults in a pharmacokinetic (PK) study, expected in the third quarter of this year.

The PK study is being performed to show that the new pediatric formulation behaves similarly to the adult formulation (which were capsules), which was tested in a Phase 1 trial in healthy adults earlier this year. After the PK study is complete, Xenon will be able to submit an IND to start a proposed Phase 2/3 clinical trial in SCN8A-EE patients.

We will update the families on the details about the final trial design, criteria, and endpoints, as they become disclosed over the coming months.
2 Comments
thuonghlv link
8/13/2020 05:42:17 am

wow! it's so exciting!

Reply
tinh link
5/30/2022 05:18:57 am

great new

Reply



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  • Home
  • About
    • About SCN8A
    • About Us
    • Partner Organizations
    • Volunteers
    • Annual Report
  • Families
    • Join our SCN8A Community
    • Connor James Smith Patient Assistance Grant
    • Educational Videos >
      • Annual Gathering Event Recordings
      • Cheers to a Good Life
      • Clinical Trial Readiness Series
      • Family and Researcher Roundtable Series
      • Meaningful Change Series
    • Resources >
      • Caregiver Support
      • Reference Guide
      • Shareable Graphics
    • CUTE Connections Grant
    • SCN8A Warriors
    • Virtual Memory Wall
  • Events
    • Annual SCN8A Clinician, Researcher, and Family Gathering >
      • CUTIES Awards
      • Speakers
    • Researcher Roundtable
    • Awareness Day
    • Layla: The Festival of Mark Making
    • Virtual 5k
  • Research
    • Clinical Trials
    • Research Grants
    • SCN8A Registry
  • Donate
  • Contact
  • Blog
  • Shop