Clinical Trial Updates (SCD)

FTX-6058

 

Update: 27 October 2021

No update available

 

Update: 30 June 2021

  • Preclinical data with FTX-6058 showed an increase in HbF levels up to approximately 30% of total haemoglobin.
  • Fulcrum has initiated a Phase 1 trial with FTX-6058 in healthy adult volunteers. Dosing has been initiated in the randomized, double-blind, placebo-controlled, multiple ascending dose (MAD) cohorts of the trial. Dosing continues in the single ascending dose (SAD) portion.
  • The company anticipates sharing data from this Phase 1 trial in mid-2021 and initiating a clinical trial in sickle cell patients by the end of 2021.

Source: https://www.globenewswire.com/news-release/2021/04/09/2207657/0/en/Fulcrum-Therapeutics-Presents-Published-Structure-of-Investigational-Small-Molecule-FTX-6058-at-the-American-Chemical-Society-ACS-Spring-2021-Virtual-Conference.html

 

Update: 08 January 2021

No update available

 

Update: 05 November 2020

An Investigational New Drug application is now in effect in the USA for a Phase 1 trial in healthy adult volunteers to investigate FTX-6058 for sickle cell disease patients.

FTX-6058 is a small molecule designed to increase fetal haemoglobin.

The Phase 1 trial will evaluate the safety, tolerability, and pharmacokinetics of FTX-6058 and will be comprised of four parts.

  1. Part A will be a randomized, double-blind, placebo-controlled, single ascending dose (SAD) study in up to six cohorts.
  2. Part B will be a randomized, double-blind, placebo-controlled, multiple ascending dose (MAD) study in up to four cohorts dosed once daily for 14 days.
  3. Part C will be an open-label pilot food effect study in subjects randomized to take FTX-6058 with and without a high-fat meal, and
  4. Part D will be an open-label study to evaluate the potential of FTX-6058 to induce CYP3A – an enzyme that helps humans metabolize or digest drugs.

Source: https://www.globenewswire.com/news-release/2020/10/05/2103395/0/en/Fulcrum-Therapeutics-to-Initiate-Phase-1-Trial-with-FTX-6058-for-Sickle-Cell-Disease.html

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