At the Inflammatory Skin Disease Summit (ISDS) in Vienna, Austria, this December, Asana BioSciences presented the first data on the Phase I trial that tested the safety, tolerability, and preliminary efficacy of ASN002 in people with moderate-to-severe atopic dermatitis. ASN002 is the first oral Janus kinase (JAK)-spleen tyrosine kinase (SYK) inhibitor to demonstrate correlations between improvements in clinical outcomes and molecular changes in the skin and serum of atopic dermatitis patients. As a result of inhibiting JAK-SYK signalling, ASN002 prevents JAK-mediated cytokine signaling and JAK-SYK-mediated T- and B-cell proliferation and function. It is not yet known for certain if the dual inhibitory action of ASN002 will provide better efficacy and safety results than conventional JAK inhibitors, but preliminary results from the ASN002 Phase I trial show great promise towards this end.
In the ASN002 Phase I trial, 36 moderate-to-severe atopic dermatitis participants were randomly split into placebo, 20mg, 40mg, and 80mg daily dose groups for four weeks in order to examine ASN002’s effect on Th1, Th2, and Th17/22 signaling, as well as changes to inflammatory biomarkers associated with the disease. Biopsies taken at baseline, Week 2, and Week 4 showed that the investigational new drug was well tolerated, with ≥79% improvement in mean Eczema Area and Severity Index (EASI) scores and an observed decrease in participant pruritus (skin itching) based on the pruritus Numerical Rating Scale (NRS). Moreover, significant correlations were seen between improvements in key Th2 and Th22 skin biomarkers at both Weeks 2 and 4, with significant and progressive reductions in serum atopic dermatitis inflammatory signature.
The announcement of the successful Phase I trial results comes days after the FDA granted ASN002 its Fast Track Designation, on December 10th. Asana BioSciences is currently evaluating the efficacy of ASN002 in the Phase IIb RADIANT trial (NCT03654755). Now that the atopic dermatitis pipeline is more active than it has been in the last 15 years, GlobalData projects that JAK inhibitors, which are expected to come to market within the next two years, will generate $4.1B by 2027. If Asana BioSciences can distinguish itself from conventional JAK inhibitors in terms of both efficacy and safety, which seems possible based on Phase I data, then ASN002 may well find itself as the go-to treatment for moderate-to-severe atopic dermatitis patients.