Upstream Bio has dosed the first subject in the randomised Phase II trial of verekitug, an antibody antagonist targeting the thymic stromal lymphopoietin (TSLP) receptor, in individuals with chronic obstructive pulmonary disease (COPD).
The double-blind, placebo-controlled VENTURE study aims to evaluate the safety and efficacy of the therapy in nearly 670 moderate-to-severe COPD adult patients.
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Subjects will be administered verekitug at 100mg one time in every 12 weeks, 400mg once every 24 weeks, or a placebo, for treatment periods ranging from 60 to 108 weeks.
The annualised rate of moderate or severe COPD exacerbations is the trial’s primary endpoint.
Secondary endpoints are changes in day-to-day symptoms and lung function measures of the patients, such as forced expiratory volume in one second (FEV₁).
The trial is said to enrol subjects irrespective of their blood eosinophil count, focusing the primary analysis on those with elevated eosinophils during screening.
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By GlobalDataThose without elevated eosinophils will also be included for exploratory analyses of the therapy’s efficacy in this subgroup.
Upstream Bio research & development head and chief medical officer Aaron Deykin said: “We are excited to expand our clinical programme for verekitug into COPD with the initiation of this clinical trial.
“Given the results observed in our preclinical and early clinical studies in asthma, we believe that as the only known biologic in development targeting the TSLP receptor, verekitug may have the potential to advance COPD treatment with less frequent dosing and differentiated efficacy as compared to currently approved biologic therapies for this condition.”
COPD is a condition where everyday activities can lead to shortness of breath and frequent exacerbations, potentially resulting in hospitalisation.
Individuals with this condition are said to be at an increased risk of developing lung infections such as pneumonia and bronchitis.
Verekitug is also undergoing evaluation in two other Phase II trials. These include the VIBRANT trial intended for those with chronic rhinosinusitis with nasal polyps (CRSwNP) and the VALIANT trial for severe asthma.
Last year, the company commenced patient dosing in the VALIANT trial for severe asthma.
