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Certa Therapeutics’ FT011 Gains the EMA’s Orphan Drug Designation to Treat Systemic Sclerosis

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Certa Therapeutics

Certa Therapeutics’ FT011 Gains the EMA’s Orphan Drug Designation to Treat Systemic Sclerosis

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  • The EMA has granted orphan drug designation to FT011 for treating Systemic Sclerosis (SSc). It has been designated with the US FDA’s ODD & FTD for the same
  • FT011 depicted favorable effectiveness across in vitro & in vivo inflammatory and fibrotic disease models with its P-I & P-IIa showing favorable efficacy, safety & PK. Certa plans a P-IIb confirmatory study and is developing biomarkers & gene signatures for identifying patients, likely to respond to fibrosis treatment
  • FT011 (oral) is an FIC therapy that works by targeting GPR68, a membrane GPCR receptor, responsible for fibrosis

Ref: Globenewswire | Image: Certa Therapeutics

Related News:- Certa Therapeutics’ FT011 Receives the US FDA’s Fast Track Designation for Treating Systemic Sclerosis

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Disha Nankani

Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.

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