US-based biopharmaceutical company Connect Biopharma has started a Phase II trial to assess the efficacy and safety of rademikibart in treating acute exacerbations of asthma and type II inflammation.
The Seabreeze STAT Asthma trial aims to enrol around 160 subjects worldwide who are experiencing an acute asthma exacerbation.
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Each subject will be given a single dose of either rademikibart or a placebo subcutaneously.
The randomised trial’s primary endpoint is to determine the efficacy and safety of the therapy when given as an adjunct to standard care, as measured by the treatment failure rate over 28 days after an acute exacerbation.
Its secondary endpoints are changes from baseline in asthma symptom score and nocturnal awakenings, the rate and time to new asthma exacerbations, and post-bronchodilator forced expiratory volume in one second (FEV1).
Connect Biopharma expects to report topline data from the trial in the first half of next year.
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By GlobalDataThe decision to begin the trial follows a written agreement from the US Food and Drug Administration (FDA) on the final protocol related to the trial.
Connect Biopharma director and CEO Barry Quart said: “We are pleased to initiate the Seabreeze STAT Asthma study as we execute on our rapid clinical development plan for rademikibart.
“With the initiation of this study, we have the potential to establish rademikibart as the first and only biologic indicated for patients experiencing an acute exacerbation of asthma and to prevent further exacerbations during the most vulnerable period in the month following an exacerbation.”
The launch of the Seabreeze STAT Asthma study comes after positive outcomes were published from a global Phase II trial of rademikibart in individuals with moderate-to-severe uncontrolled asthma.
This study’s data underscore the drug’s capacity to swiftly enhance lung function within 24 hours post-administration, alongside sustained lung function improvements over 24 weeks.
