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SpliSense’s IND of SPL84 Receives the US FDA’s Clearance to Conduct P-II Study for Treating Cystic Fibrosis

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SpliSense’s IND of SPL84 Receives the US FDA’s Clearance to Conduct P-II Study for Treating Cystic Fibrosis

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  • SpliSense’s IND of SPL84 has been cleared by the US FDA to commence the P-II clinical evaluation in CF due to its favorable safety profile supported by P-I data. Preclinical studies demonstrated its ability to fully restore CFTR protein & activity, based on clinically predictive CF models
  • Furthermore, the company has obtained funding from the CF Foundation & other investors that will be utilized for the development of SPL84’s P-II study & other pulmonary programs
  • SPL84, administered to the lungs through inhalation, works by binding with the mutated CFTR RNA in the targeted sequence and modulates it to produce fully functional CFTR proteins

Ref: PR  Newswire | Image: SpliSense

Related News:- Vertex Receives CHMP’s Positive Opinion for Kalydeco as a Treatment of Cystic Fibrosis in Infants

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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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