1st Order Pharmaceuticals Inc: 1OP-2198

Discussion in 'Research News' started by Mic, Jan 25, 2017.

    1. Autumnly

      Autumnly Member Podcast Patron Benefactor Ambassador Hall of Fame Advocate

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      Xenon Announces Final Results of XEN1101 Phase 1 Clinical Trial and Update on XEN901 Phase 1 Clinical Trial at the American Epilepsy Society (AES) Annual Meeting
      • XEN1101 is a Kv7 potassium channel modulator being developed for the treatment of epilepsy and potentially other neurological disorders
      • Xenon today outlined plans for a XEN1101 Phase 2 clinical trial, with patient enrollment expected to begin early in the new year
      • Pharmacokinetics: The PK profile of XEN1101 (including an effective half-life greater than 24 hours) supports a once-per-day dosing schedule with expected steady state in approximately one week without the need for titration
      • Safety: The majority of adverse events (AEs) were mild or moderate, resolved spontaneously and were consistent with antiepileptic drugs of this class. Sedation (including somnolence, drowsiness) and dizziness (including light-headedness and presyncope) were the most common AEs, while mild cognitive effects (memory and speech impairment) and blurred vision were also observed in a dose dependent manner. There were no SAEs, deaths, or clinically significant ECG or laboratory findings. Phase 1 results suggest that that XEN1101 is generally safe and well tolerated in the doses examined (single doses of up to 30 mg and multiple doses of up to 25 mg once daily).
      About the XEN1101 Phase 2 Clinical Trial
      • patient enrollment expected to begin early in 2019
      • randomized, double-blind, placebo-controlled, multicenter study to evaluate the clinical efficacy, safety and tolerability of XEN1101 administered as adjunctive treatment in adult patients aged 18 to 75 years diagnosed with focal epilepsy
      • Approximately 300 patients
      • After screening, patients will have 8 weeks of baseline to assess frequency of seizures, followed by 8 weeks of treatment and a 4-week post treatment follow-up period
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    2. Deamon22

      Deamon22 Member Podcast Patron Benefactor Ambassador

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      @Autumnly thank you for providing updates:)
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    3. friend74

      friend74 Member

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      Are there any (hopefully good) news regarding the latest trials or the drug itself?
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