Upstream Bio has initiated the dosing of the first subjects in a Phase II clinical trial of its monoclonal antibody, verekitug, for chronic rhinosinusitis with nasal polyps (CRSwNP).
A lead programme of the company, verekitug is a recombinant fully human immunoglobulin G1 monoclonal antibody that acts on the thymic stromal lymphopoietin receptor (TLSPR).
This approach aids in mitigating the thymic stromal lymphopoietin (TSLP)-driven inflammation, a dominant factor in CRSwNP and other inflammatory ailments.
The double-blind, randomised, placebo-controlled trial is designed to assess the efficacy of 100mg subcutaneously injected doses of verekitug given every 12 weeks to treat CRSwNP patients.
A decline in nasal polyp score is the trial’s primary goal.
Upstream Bio CEO Sam Truex said: “This Phase II trial presents the opportunity for Upstream Bio to demonstrate verekitug’s potential as a best-in-class biologic for the treatment of a broad range of allergic and inflammatory conditions.”
Combined findings from Phase II trials in CRSwNP and asthma will contribute to the selection of dosage regimens for subsequent Phase III trials in both indications.
Verekitug has shown promise in pre-clinical studies, effectively inhibiting cytokine production and indicating its potential against various other inflammatory responses.
In three Phase I trials, verekitug was found to be safe and well-tolerated.
Notably, in a Phase Ib study, verekitug maintained prolonged target engagement and inhibition of disease-related biomarkers in asthma patients.
Upstream Bio research and development chief medical officer and head Aaron Deykin said: “Enabled by the large and durable effects of verekitug on exhaled nitric oxide and blood eosinophils demonstrated in our recently completed Phase Ib study in asthma patients, we are thrilled to now move verekitug into Phase II in CRSwNP.
“The high potency data documented in our previous studies support a dosing interval of at least every 12 weeks.
“We also plan to initiate a Phase II study in asthma this quarter that will include dosing intervals of 12 weeks and 24 weeks.”
