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A pivotal phase ll/lll trial evaluating efficacy of QBM-001 for the treatment of young children with a rare autistic spectrum disorder

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A pivotal phase ll/lll trial evaluating efficacy of QBM-001 for the treatment of young children with a rare autistic spectrum disorder

Status: Planning
Phase of Trial: Phase II/III

Latest Information Update: 11 Jun 2019

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At a glance

  • Drugs QBM-001 (Primary)
  • Indications Pervasive child development disorders
  • Focus Registrational; Therapeutic Use
  • Sponsors Q BioMed

    • Most Recent Events

    • 04 Jun 2019 According to a Q BioMed media release, company anticipates IND submissions, including its current clinical trial design which is planned and ready to propose, by December of this year. This study is expected to commence as early as Q1 2020.
    • 08 Jan 2019 According to a Q BioMed media release, IND filling is anticipated by the end of Q2 2019 and the trial is expected to start in Q3 2019. This trial is expected to take about a year to 18 months and we could have interim data reviewed by Q1 of 2020.
    • 12 Dec 2018 According to a Q BioMed media release, the company has announced a collaborative agreement with SRI International to provide formulation development, preclinical development, and early clinical manufacturing of QBM-001, in support of Q BioMed's Autistic Spectrum Disorder (ASD) drug development program for non-verbal or minimally verbal autistic children, including this trial which is expected to start in 2019.

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