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

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Certa Therapeutics

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

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  • Certa’s FT011 has received the US FDA's FTD to treat systemic sclerosis (SSc) based on the PBO-controlled P-II trial investigating its safety and PK/PD effects for SSc
  • The top-line data revealed a clinically favorable improvement with FT011 (400mg) in 60% of patients & with FT011 (200mg) in 20% of them vs 10% with PBO. 3 patients attained a max. CRISS score of 1.0 in the combined FT011 groups, indicating a higher probability of improvement
  • FT011 (oral) is a novel, FIC, GPR68 targeting therapy indicated to treat chronic fibrosis in various organs. Moreover, the transcriptomic research has confirmed its ability to reverse genetic markers’ activation associated with fibrosis, indicating potential for personalized medicine

Ref: Certa Therapeutics | Image: Certa Therapeutics

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Shivani Chandra

Shivani is a content writer at PharmaShots. She has a keen interest in recent innovations in the life sciences industry. She covers news related to Product approvals, clinical trial results, and updates. She can be contacted at connect@pharmashots.com.

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