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Theravance Biopharma Reports Positive Results from Phase 1 Clinical Trial of TD-8236, an Investigational, Lung-Selective, Inhaled Pan-Janus Kinase (JAK) Inhibitor for Inflammatory Lung Diseases
DUBLIN, Sept. 9, 2019 /PRNewswire/ -- Theravance Biopharma, Inc. (NASDAQ: TBPH) ("Theravance Biopharma" or the "Company") today announced initial results,
About this update from Theravance Biopharma, Inc.
[{"type":"text","content":"DUBLIN, Sept. 9, 2019 /PRNewswire/ -- Theravance Biopharma, Inc. (NASDAQ: TBPH) (\"Theravance Biopharma\" or the \"Company\") today announced initial results, including positive biomarker responses, from its Phase 1 single-ascending dose (SAD) and multiple-ascending dose (MAD) clinical trial of TD-8236, an investigational, lung-selective inhaled pan-Janus kinase (JAK) inhibitor for inflammatory lung diseases. TD-8236 is specifically designed to be delivered to the lung via dry powder inhalation, targeting airway inflammation in the lung with minimal systemic exposure.\n\n \nData from the study demonstrated TD-8236 to be generally well tolerated as a single dose (up to 4500 mcg) in healthy subjects and as a once-daily dose (up to 4000 mcg) given for seven consecutive days in patients with mild asthma. There was no evidence of local irritation or bronchoconstriction. There were no severe or serious adverse events reported and no subject discontinued due to adverse events. The majority of adverse events (AEs) were deemed to be mild and all AEs resolved by follow-up visits. None of the AEs were considered related to TD-8236 and there were no clinically relevant changes seen in any safety laboratory measures including hematologic parameters, or in electrocardiograms or vital sign assessments. \nThe trial also quantified the amount of TD-8236 that entered the systemic circulation following inhaled administration. These pharmacokinetic results showed that plasma levels of TD-8236 in study subjects were several orders of magnitude below the levels predicted to cause systemic pharmacological activity, which is consistent with data from preclinical studies and the organ-selective design of the compound.\nAn additional objective of the Phase 1 program was to determine biological evidence of an anti-inflammatory effect in the lungs of asthma patients. Evidence of the biological activity of TD-8236 in the lung was demonstrated in the repeat dose portion of the study, which recruited patients with mild asthma who had elevated levels of fractional exhaled nitric oxide (FeNO). FeNO is an established disease activity biomarker in asthma, and reductions in FeNO are associated with a decrease in airway inflammation. Over the seven days of TD-8236 administration once daily by inhalation, patients experienced reductions in both pre-dose and six-hour...