Phase 2 (Top-line Data)
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Catalyst Info & Data Links
TITLE: TD-0903 (Janus kinase inhibitor (JAKi)) for COVID-19 - Phase 2
ClinicalTrial.gov (NCT04402866): TD-0903 for ALI Associated With COVID-19
WHAT IS THE CATALYST EVENT?
Phase 2 Top-Line Data
WHEN WILL THE EVENT (OR DID THE EVENT) OCCUR?
MECHANISM OF ACTION
JAK inhibitors function by inhibiting the activity of one or more of the Janus kinase family of enzymes (JAK1, JAK2, JAK3, TYK2) that play a key role in cytokine signaling. Inhibiting these JAK enzymes interferes with the JAK/STAT signaling pathway and, in turn, modulates the activity of a wide range of pro-inflammatory cytokines. Limiting JAK inhibition to the lung is expected to improve the therapeutic index relative to systemic inhibition. Thus, inhaled JAK inhibitors with lung-restricted exposure are of high interest as potential treatments for respiratory illness.
TD-0903 is a lung-selective, nebulized pan-JAK inhibitor that was discovered and developed at Theravance Biopharma. TD-0903 has been shown in experimental murine models to have potent, broad inhibition of JAK-STAT signaling in the airways following challenges with multiple cytokines. By its mechanism, TD-0903 has the potential to block the release of cytokines and chemokines that may be associated with Acute Lung Injury and the initiation of a cytokine storm syndrome. Preclinical studies suggest that TD-0903 has a very high lung:plasma ratio and rapid metabolic clearance resulting in low systemic exposure, compatible with its lung selectivity. TD-0903 is administered via a nebulized inhalation solution, which further enhances its lung selectivity. Preclinical pharmacodynamic studies indicate that TD-0903 has an extended duration of action that should enable once or twice daily dosing in humans.
Updated by HC
TBPH, COVID-19, Coronavirus, infectious disease, TD-0903 (Janus kinase inhibitor (JAKi))
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