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Clinical Trial Updates (SCD)

Pociredir

  • Product Information

    Product Information

    Scientific name: Pociredir
    Brand name: Ν/Α
    RESPONSIBLE: Fulcrum Therapeutics

  • Clinical Trial/Study Information

    Clinical Trial/Study Information

    Trial Name: PIONEER
    Code: NCT05169580
    Phase: 1b
    Eligible patient diagnosis: : SCD
    No. of Patients enrolled: 70 [anticipated] (Last update: 17/06/2024)
    Study Sites: 10 Sites per country

    Completion date: April 2025
    Scope of the Study / Aim: Evaluate the safety and tolerability of FTX-6058 (pociredir)

  • Regulatory Information

    Regulatory Information

    Status: Not Authorised

     

    Additional notable points:

    • EMA: N/A
    • FDA: N/A
    • MHRA: N/A
Update: 19 December 2024

No update available.

 

Update: 30 September 2024

No update available.

 

Update: 30 June 2024

Data presented at the 29th EHA Annual Congress (13 – 16 June 2024) in Madrid (Spain) from 3 dose-finding cohorts (6mg, 2mg and 12mg) to induce fetal haemoglobin (HbF) enrolled 10, 2 and 4 patients respectively, showed that:

    • All patients adherent to the once daily oral administration of pociredir had HbF induction with increases of 9.8% and 10&% in the 6mg and 12mg cohorts respectively.
    • Dose dependent increases were not affected by hydroxyurea use.

Source: Interim Results of a Phase 1b Study (Pioneer) of an Oral Hbf Inducer, Pociredir, in Sickle Cell Disease

 

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