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A multiple ascending dose (MAD) clinical trial of CTI-1601 in patients with Friedreich's-ataxia under 18 years of age

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Trial Profile

A multiple ascending dose (MAD) clinical trial of CTI-1601 in patients with Friedreich's-ataxia under 18 years of age

Status: Planning
Phase of Trial: Phase I

Latest Information Update: 01 Nov 2022

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At a glance

  • Drugs Nomlabofusp (Primary)
  • Indications Friedreich's ataxia
  • Focus Adverse reactions
  • Most Recent Events

    • 19 Oct 2022 According to Larimar Therapeutics media release, the data from phase I clinical program evaluating CTI-1601 for the treatment for Friedreich's Ataxia will be featured in the three presentations at the upcoming International Congress for Ataxia Research. The conference will take place from 1st-4th November 2022 in Dallas, Texas, USA.
    • 14 Sep 2022 According to a Larimar Therapeutics media release, in a written communication to Larimar, the FDA indicated it was lifting its full clinical hold on the CTI-1601 program and imposing a partial hold.
    • 12 May 2022 According to a Larimar Therapeutics media release, the company had requested for an FDA Type C meeting, which has been granted and has been scheduled for early in the third quarter of 2022. The Company plans to provide a regulatory update on CTI-1601 following receipt of the minutes from the scheduled Type C meeting with the FDA.
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