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GBT Reports Initiation of the P-II/III Study of GBT601 for the Treatment of Sickle Cell Disease

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GBT Reports Initiation of the P-II/III Study of GBT601 for the Treatment of Sickle Cell Disease

GBT Reports Initiation of the P-II/III Study of GBT601 for the Treatment of Sickle Cell Disease

Shots:

  • The P-II portion evaluates the safety, tolerability, efficacy, PK & PD of GBT601 (100/150/200mg) in the ratio of 1:1:1 in patients (n=60) aged 18-65yrs. with SCD, planned to include sites in Africa, the EU, the Middle East, South America & the US
  • The 1EP of the study will measure a change from baseline in Hb @12wks & the 2EP will evaluate the PK, PD along with the relationship b/w GBT601 & measures of anemia/hemolysis. The results from the P-I & P-II study are expected by the YE'22
  • The P-III study will evaluate the safety & efficacy of the selected optimal dose of GBT601 vs PBO in patients for 48wks. The 3rd arm of the study will evaluate the PK & safety of single/multiple doses of GBT601 in pediatric patients

Ref: GBT | Image: GBT

Click here to­ read the full press release 

Neha

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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