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A Combined Phase IIb/III, Multicenter, Enriched Enrollment, Case Controlled Withdrawal Trial Designed to Assess Safety, Tolerability and Efficacy of Trehalose IV in Sanfilippo A and B

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Trial Profile

A Combined Phase IIb/III, Multicenter, Enriched Enrollment, Case Controlled Withdrawal Trial Designed to Assess Safety, Tolerability and Efficacy of Trehalose IV in Sanfilippo A and B

Status: Planning
Phase of Trial: Phase II/III

Latest Information Update: 15 Sep 2020

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At a glance

  • Drugs Trehalose (Primary)
  • Indications Mucopolysaccharidosis III
  • Focus Adverse reactions; Proof of concept; Registrational; Therapeutic Use
  • Sponsors Seelos Therapeutics

    • Most Recent Events

    • 08 Apr 2020 Accordding to a Seelos Therapeutics media release, the company is continuing discussions with the FDA regarding the use of Sanfilippo syndrome natural history data as a control for a pivotal study in the U.S. Seelos is currently collecting additional natural history data for that purpose.
    • 08 Nov 2019 According to a Seelos Therapeutics media release, the company expect screening and dosing to commence in this phase IIb/III trial in Sanfilippo syndrome in the US for SLS-005.
    • 22 Aug 2019 According to a Seelos Therapeutics media release, the company continue to engage with additional clinical trial sites to accommodate enrollment for this trial.

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