Theravance inhalable lung med shows encouraging action in early-stage study

Initial data from a Phase 1 clinical trial evaluating single and multiple ascending doses of Theravance Biopharma’s (TBPH -0.1%) inhalable JAK inhibitor TD-8236 in healthy volunteers and patients with mild asthma showed a favorable safety profile.

Single doses up to 4,500 mcg in healthy subjects and daily doses of up to 4,000 mcg for seven consecutive days in mild asthma sufferers were generally well-tolerated with no evidence of local irritation or bronchoconstriction. Most adverse events were mild and all were resolved by follow-up visits.

On a pharmacokinetic basis, plasma levels of TD-8236 were several orders of magnitude below those predicted to cause systemic pharmacological activity (therapeutic effect should be restricted to the lungs).

The company has initiated a Part C extension portion that will assess a range of additional biomarkers in patients with more severe asthma. A Phase 2 lung allergen challenge study will also be launched.

https://seekingalpha.com/news/3498013-theravance-inhalable-lung-disease-candidate-shows-encouraging-action-early-stage-study