Theravance Biopharma announced that the first patient has been dosed in a Phase 2 study of its TD-8236 inhaled dry powder pan-JAK inhibitor which the company is developing for the treatment of inflammatory lung diseases. In September 2019, the company announced positive results from a Phase 1 SAD/MAD study of TD-8236.
The Phase 2 allergen challenge study will compare two doses of TD-8236 to placebo in 21 patients who have mild asthma. Following an inhaled allergen challenge, patients will receive either TD-8236 or the placebo once daily for 14 days, with the asthmatic response after the 14-day dosing period as the primary endpoint.
Theravance Biopharma Chief Medical Officer Brett Haumann said, “The initiation of this allergen challenge study represents a key milestone in our development of TD-8236, a novel lung-selective pan-JAK inhibitor designed for the treatment of patients with moderate to severe asthma who are not controlled with existing inhaled corticosteroid therapy. Allergen challenge studies provide a well-established proof-of-concept, correlating with a broader set of clinical responses in later studies in patients with asthma. As such, we expect this trial will build upon the findings from our Phase 1 study and provide key additional insights that will further inform our future clinical trials for TD-8236.”
Read the Theravance Biopharma press release.
