Asana BioSciences, a clinical stage biopharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Asana’s investigational oral Janus Kinase (JAK) and Spleen Tyrosine Kinase (SYK) dual inhibitor ASN002 for the treatment of moderate-to-severe atopic dermatitis. “We are pleased that the FDA has granted Fast Track designation to ASN002. This designation recognizes the importance of accelerating the development of new medicines for the treatment of challenging dermatological/inflammatory diseases that have a major impact on patients’ daily quality of life,” said Sandeep Gupta, Founder and CEO of Asana. “We look forward to taking advantage of the opportunity for frequent interactions with the FDA throughout the development of ASN002 and the potential expedited review offered by their Fast Track program.”
ASN002 is currently being evaluated in moderate-to-severe atopic dermatitis in the Phase 2b RADIANT Study (Relief from Atopic DermatitIs with JAK and SYK INhibiTion – NCT03654755). It is also being evaluated in a Phase 2 trial in patients with severe chronic hand eczema (NCT03728504).
ASN002 is the first oral drug to demonstrate improvement in atopic dermatitis lesional skin phenotype correlating with clinical efficacy. ASN002 data demonstrating improvements in skin pathology, disease related genes and inflammation biomarkers, correlating with clinical efficacy in patients with moderate-to-severe atopic dermatitis, will be presented at the Inflammatory Skin Disease Summit (ISDS) meeting to be held in Vienna, Austria, December 12-15, 2018.
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