TBPH

TD-0903 (Janus kinase inhibitor (JAKi))

COVID-19

Phase 2 (Top-line Data)

Exp Date

Q2 2021

Amp Volatility Score

N/A

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?


PRIOR DATA/EVENTS

PRESS RELEASE

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))

Prior Data (click to view full image)

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Trial Design / Revenue (click to view full image)

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