Asana BioSciences’ Gusacitinib Granted FDA Fast-Track Designation for Moderate-to-Severe Chronic Hand Eczema
Asana BioSciences, a clinical stage biopharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast-Track designation to Asanas gusacitinib (ASN002), an investigational oral, dual inhibitor of Janus Kinase (JAK) and Spleen Tyrosine Kinase (SYK), for the treatment of moderate-to-severe Chronic Hand Eczema (CHE).
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 gusacitinib (ASN002), an investigational oral, dual inhibitor of Janus Kinase (JAK) and Spleen Tyrosine Kinase (SYK), for the treatment of moderate-to-severe Chronic Hand Eczema (CHE).
According to International Eczema Council, CHE is a common and often-debilitating inflammatory skin condition that affects approximately 10% of the population, more often in high-risk occupational workers. Patients with CHE suffer greatly from this disease, which limits their ability to work and perform activities of daily living. There are no approved treatments for patients suffering from CHE in the U.S. and in many other major markets. Currently used topical and systemic treatments often do not work well in moderate-to-severe CHE and patients often become resistant to these unapproved therapies.
“We are pleased that the FDA has granted Fast-Track designation to gusacitinib. This designation recognizes the importance of accelerating the development of new medicines for the treatment of challenging dermatological/inflammatory diseases such as CHE 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 potential expedited review offered by FDA Fast-Track and initiate phase 3 pivotal studies to support marketing authorization in the second half of 2021.”
Disease drivers of CHE are thought to be multifactorial with genetics, atopy, contact allergens and irritating substances playing a role in ‘triggering’ the disease. Gusacitinib, by inhibiting SYK and JAK (including TYK2) signaling, can impact several pathways involved in inflammation of CHE and other dermatologic and inflammatory diseases.
In a recently concluded phase 2b study in moderate-to-severe CHE patients, gusacitinib achieved rapid, dose-dependent, clinically meaningful, and statistically significant effects relative to placebo. Significant improvements (p <0.005) were observed as early as 2 weeks in both mean modified total lesion severity score (mTLSS; primary endpoint) and the physician global assessment (PGA; secondary endpoint), and the effects were sustained for the duration of the study (32 weeks). Safety results also show that gusacitinib was well-tolerated. The most common treatment-emergent adverse events observed were upper respiratory tract infection, headache, nausea, and nasopharyngitis. The study was a randomized, double-blind, placebo-controlled, parallel-group study evaluating oral gusacitinib (40 mg or 80 mg once daily) for up to 32 weeks, with the primary endpoint at week 16 (NCT03728504). Gusacitinib is a potential best-in-class SYK/JAK inhibitor and has been studied in over 400 subjects to date in multiple indications.
About Asana BioSciences, LLC
Asana BioSciences is a clinical stage biopharmaceutical company based in Lawrenceville, NJ. Asana is focused on discovery and development of novel targeted investigational medicines in immunology/inflammation and oncology.
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