GLOBAL RESEARCH ARCHIVE
Seabreeze STAT Asthma Phase 2 Trial Completed Enrollment, with Data Expected in Early September. COPD Trial Enrollment Expected to Complete Later in June.
Research evidence excerpt
Seabreeze STAT Asthma Phase 2 Trial Completed Enrollment, with Data Expected in Early September. COPD Trial Enrollment Expected to Complete Later in June.
analyzed in each trial 4wk after treatment, followed by a subsequent 4wk follow-up period. Treatment failure includes death
(any cause), (re)admission to hospital, urgent visit to outpatient/ED provider for symptom worsening, or necessity to intensify
pharmacologic treatment. Secondary endpoints include rate of exacerbation and time to new exacerbation, absolute change in
post-bronchodilator FEV1, mean change in respiratory symptoms, and safety. Other key exploratory endpoints include time to
ready for discharge in hospitalized patients and disease-specific PROs.
Rademikibart seems to have the fastest onset of effect among IL-4Rα Tx options in the US; Tx onset likely a key differentiator
in the acute setting. Outside rademikibart, dupilumab and LQ036 (Novamab [Private]) are the only IL-4Rα inhibitors in active
development in the US and with clinically established PK we are aware of. Of these, rademikibart showed the fastest Tmax
with IV dosing (LQ036 administration is currently limited to nebulized inhalation). Our KOL checks indicate that there is a realBIOTECHNOLOGY
opportunity for a biologic with demonstrated benefit within 1-6h and supportive clinical evidence within the Tx paradigm for
acute exacerbations in asthma/COPD. Given rademikibart’s rapid onset (preliminary Phase 1 IV data showed efficacy as early as
15min) and dupilumab’s lack of clinical studies in the acute setting, we think rademikibart looks best positioned to emerge as
the first and preferred biologic for acute use.EQUITY
Phase 2b results supported rademikibart’s differentiated onset of action, strengthening potential positioning within the acute
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