Upstream Bio Launches Phase 2 Trial for Verekitug (UPB-101) in Severe Asthma, Administers Initial Doses to Patients
Friday, March 08, 2024
Upstream Bio, a clinical-stage biotech company focusing on developing new therapies for inflammation, has announced the initiation of dosing for the first patients in its Phase 2 VALIANT clinical trial of verekitug (UPB-101) in individuals with severe asthma. Verekitug is a recombinant fully human immunoglobulin G1 monoclonal antibody designed to block the thymic stromal lymphopoietin receptor (TLSPR) and inhibit TSLP-driven inflammation. The company is currently investigating verekitug in a Phase 2 study for patients with chronic rhinosinusitis with nasal polyps (CRSwNP).
Aaron Deykin, Head of R&D and Chief Medical Officer, expressed excitement about starting the Phase 2 study in severe asthma, citing positive results from the multiple ascending dose (MAD) study. The MAD study showed a significant reduction in disease-related biomarkers, particularly with the 100 mg dose, which exhibited a 54% reduction from baseline in FeNo and EOS at week 12, sustained through week 32. These findings not only indicate higher potency compared to published data from tezepelumab but also enable the investigation of extended dosing regimens in Phase 2.
The VALIANT study is a randomized, double-blind, placebo-controlled trial evaluating verekitug in doses of 100 mg every 24 weeks (Q24W), 400 mg Q24W, 100 mg every 12 weeks (Q12W), or placebo administered subcutaneously in a single injection. The primary endpoint of the study is the annual asthma exacerbation rate (AAER), reflecting verekitug's efficacy in treating severe asthma.
Sam Truex, Chief Executive Officer, highlighted verekitug's potential as a leading inhibitor of TSLP signaling, based on its rapid and sustained effect on clinically relevant biomarkers, which are known to correlate with AAER. He expressed the company's commitment to demonstrating how verekitug's high potency translates into clinical benefits for patients with various types of asthma in global Phase 2 studies.
Verekitug, a novel recombinant fully human immunoglobulin G1 monoclonal antibody, inhibits TSLP signaling and has demonstrated effectiveness in preclinical studies against various types of inflammation. Phase 1 studies have shown that verekitug is safe and well-tolerated, with Phase 1b demonstrating sustained target engagement and maximal inhibition of disease-related biomarkers in asthma patients even 24 weeks after the last dose.
The company's primary focus is on asthma, a chronic lung disease affecting approximately 350 million people worldwide, with severe asthma affecting 5-10% of sufferers. CRSwNP, a chronic upper airway disease, is highly comorbid with asthma and is also a target indication for verekitug.
TSLP signaling blockade presents a promising therapeutic strategy for allergic and inflammatory diseases such as asthma. By targeting TSLP upstream in the inflammatory cascade, verekitug has the potential to impact multiple pathological inflammatory processes across a broad set of diseases.
Source: businesswire.com
