- 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.