The Food and Drug Administration (FDA) has granted Fast Track designation to gusacitinib (ASN002; Asana BioSciences) for the treatment of moderate to severe chronic hand eczema.
The designation is supported by data from a randomized, double-blind, placebo-controlled phase 2b study that compared the efficacy and safety of gusacitinib, an oral dual inhibitor of Janus kinase and spleen tyrosine kinase, to placebo in 97 adult patients with moderate to severe chronic hand eczema.
Findings from the study showed clinically meaningful and statistically significant effects with gusacitinib. Significant improvements (P <.005) in mean modified total lesion severity score (primary end point) and the physician global assessment (secondary end point) were observed as early as 2 weeks and were sustained for 32 weeks.
As for safety, gusacitinib was well tolerated with the most common treatment-emergent adverse events being upper respiratory tract infection, headache, nausea, and nasopharyngitis.
“We look forward to taking advantage of the potential expedited review offered by FDA Fast-Track and initiate phase 3 pivotal studies to support marketing authorization in the second half of 2021,” said Sandeep Gupta, Founder and CEO of Asana.
Asana BioSciences’ gusacitinib granted FDA Fast-Track designation for moderate-to-severe chronic hand eczema. [press release]. Lawrenceville, NJ: Asana BioSciences; February 3, 2021.
This article originally appeared on MPR