Theravance Biopharma Announces Dosing of First Patient in Phase 2 Allergen Challenge Study of TD-8236, an Investigational, Lung-Selective, Inhaled Pan-Janus Kinase (JAK) Inhibitor for Inflammatory Lung Diseases

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[{"type":"text","content":"DUBLIN, Dec. 3, 2019 /PRNewswire/ -- Theravance Biopharma, Inc. (NASDAQ: TBPH) (\"Theravance Biopharma\" or the \"Company\") today announced dosing of the first patient in a Phase 2 allergen challenge study of TD-8236, an investigational, lung-selective inhaled pan-Janus kinase (JAK) inhibitor for inflammatory lung diseases. TD-8236 is specifically designed to target airway inflammation in the lung with minimal systemic exposure and be delivered to the lung via dry powder inhalation.\n\n \nThe Phase 2 trial is a randomized, double-blind, placebo-controlled, crossover allergen challenge study designed to evaluate two doses of TD-8236 compared to placebo in 21 patients with mild asthma following an inhaled allergen challenge. The primary objective of the study will be characterization of the late asthmatic response (LAR) after inhaled allergen challenge following 14 days of TD-8236 (inhaled once daily) or matched placebo. Secondary objectives of the study will include safety, tolerability, and PK assessments. \n\"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,\" said Brett Haumann, MD, chief medical officer of Theravance Biopharma. \"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.\" \nTheravance Biopharma recently announced positive results from a Phase 1 trial of TD-8236 in healthy subjects and mild asthmatics. Study data demonstrated TD-8236 to be generally well tolerated with minimal systemic exposure, which is consistent with data from preclinical studies and the organ-selective design of the compound. Additionally, the study demonstrated reductions in fractional exhaled nitric oxide (FeNO) in patients with mild asthma and elevated FeNO levels at baseline. FeNO is an established disease activity biomarker in asthma, and reductions in FeNO are associated with a decrease in airway inflammation.\nAn ...

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