Phase IIb trial of BIO 101 in patients with sarcopenic obesity

Trial Profile

Phase IIb trial of BIO 101 in patients with sarcopenic obesity

Planning
Phase of Trial: Phase II

Latest Information Update: 25 Sep 2017

At a glance

  • Drugs Sarconeos (Primary)
  • Indications Muscular atrophy
  • Focus Therapeutic Use
  • Acronyms SARA INT; SARA-INT
  • Sponsors Biophytis
  • Most Recent Events

    • 25 Sep 2017 According to a Biophytis media release, the company has filed an IND with the US FDA to start this trial. The protocol has been adjusted to take into account the scientific opinion of the European Medicines Agency (EMA). In the coming days, approval will also be filed in Europe: Belgium, France and Italy. Roger A. Fielding of Tufts University is the principal investigator of this trial.
    • 16 Dec 2016 According to a Biophytis media release, data from SARA-PK study will be used for filing regulatory approvals in Europe and the US of the Phase 2b SARA-INT trial.
    • 16 Dec 2016 According to a Biophytis media release, this trial is expected to initiate by mid-2017.
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