Pociredir
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Product Information
Scientific name: Pociredir
Brand name: Ν/Α
RESPONSIBLE: Fulcrum Therapeutics -
Clinical Trial/Study Information
Trial Name: PIONEER
Code: NCT05169580
Phase: 1b
Eligible patient diagnosis: : SCD (ages 18 – 65)
No. of Patients enrolled: 70 [anticipated] (Last update: 17/06/2024)
Study Sites: 16 Sites per countryCompletion date: December 2025
Scope of the Study / Aim: Evaluate the safety and tolerability of FTX-6058 (pociredir) -
Regulatory Information
Status: Not Authorised
Additional notable points:
- EMA: N/A
- FDA: N/A
- MHRA: N/A
Enrolment is complete for the groups receiving 2mg, 6mg and 12mg. Begun enrolment for the 20mg dose group.
Update: 31 March 2025
No update available.
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:
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- 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.
