The Food and Drug Administration (FDA) has granted Fast Track designation to the investigational oral dual inhibitor, ASN002 (Asana BioSciences), for the treatment of moderate-to-severe atopic dermatitis.
ASN002 works by inhibiting both oral Janus Kinase (JAK) and Spleen Tyrosine Kinase (SYK) inhibitors. This combination is the first oral treatment to demonstrate improvements in skin phenotype correlating with clinical efficacy, according to the Company in a press release.
The phase 2b RADIANT study (Relief from Atopic DermatitIs with JAK and SYK INhibiTion; NCT03654755) is currently evaluating ASN002 in 256 patients with moderate-to-severe atopic dermatitis. The open-label extension study is assessing ASN002 40mg, 60mg, and 80mg daily doses for up to 110 weeks. The primary outcome measure is the nubmer and rate of treatment-emergent adverse events (TEAEs).
Preliminary findings have demonstrated improvements in skin pathology, disease related genes and inflammation biomarkers in moderate-to-severe atopic dermatitis. This data will be presented at the Inflammatory Skin Disease Summit being held in Austria this week.
ASN002 is also being studied in a phase 2 randomized, double-blind, placebo-controlled trial (NCT03728504) in 75 patients with severe chronic hand eczema refractory to topical corticosteroids. The estimated study completion is May 2020.
“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,” said Sandeep Gupta, founder and CEO of Asana.
For more information visit AsanaBiosciences.com.