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A Phase 1 Open-Label, Multiple-Dose Study to Evaluate Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of FTX-6058 in Subjects With Sickle Cell Disease (SCD)

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Trial Profile

A Phase 1 Open-Label, Multiple-Dose Study to Evaluate Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of FTX-6058 in Subjects With Sickle Cell Disease (SCD)

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 12 Jun 2025

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At a glance

  • Drugs Pociredir (Primary)
  • Indications Sickle cell anaemia
  • Focus Adverse reactions; Pharmacokinetics; Proof of concept
  • Acronyms PIONEER
  • Sponsors Fulcrum Therapeutics

Most Recent Events

  • 29 May 2025 According to a Fulcrum Therapeutics media release, trial design will be presented at the 5th Global Congress on Sickle Cell Disease.
  • 01 May 2025 According to a Fulcrum Therapeutics media release, enrollment is complete in 12 mg dose cohort (n=16) with greater than 90% rates of adherence to study drug and no patient discontinuations to date. Based on the recommendation of the data monitoring committee, Fulcrum has initiated the 20 mg dose cohort and plans to share data from the 12 mg dose cohort in early Q3 2025 and from the 20 mg dose cohort by the end of 2025.
  • 25 Feb 2025 According to a Fulcrum Therapeutics media release, company Having recently enrolled the 10th patient in the 12 mg dose cohort, we remain on track to share important clinical data this year, including data from the 12 mg dose cohort in mid-2025 and data from the 20 mg dose cohort by the end of the year.

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