Phase 2 Trial Begins for Verekitug in CRSwNP Patients

Upstream Bio, a biotech firm focused on developing innovative treatments for inflammatory conditions, has initiated a Phase 2 clinical trial for verekitug, a monoclonal antibody, in patients with chronic rhinosinusitis with nasal polyps (CRSwNP). The drug is designed to target and block the thymic stromal lymphopoietin receptor (TLSPR), which is a significant contributor to inflammation in CRSwNP, asthma, and other allergic and inflammatory diseases.
The Phase 2 study follows positive results from a Phase 1b trial in asthma patients, where verekitug showed significant effects on exhaled nitric oxide and blood eosinophils. The company's Chief Medical Officer, Aaron Deykin, MD, highlighted the drug's potential for a dosing interval of at least every 12 weeks based on these results. A Phase 2 asthma study is also planned for the near future, with dosing intervals of 12 and 24 weeks.
The CRSwNP trial is a rigorous, placebo-controlled investigation that will assess the efficacy of a 100 mg subcutaneous dose of verekitug administered every 12 weeks. The primary goal is to measure the reduction in nasal polyp score. The outcomes of this and the concurrent asthma study will guide the dosing strategy for Phase 3 trials in both conditions.
Sam Truex, CEO of Upstream Bio, expressed optimism that verekitug could emerge as a leading biological treatment for a range of allergic and inflammatory diseases. He anticipates that the drug's demonstrated ability to rapidly and substantially reduce disease biomarkers will translate into significant benefits for CRSwNP patients, with the added advantage of infrequent dosing.
Thymic Stromal Lymphopoietin (TSLP) is a cytokine that initiates the inflammatory cascade in various diseases, making it an attractive therapeutic target. By blocking the TSLP receptor, verekitug could potentially address these diseases at their origin, before other cytokines become involved. Verekitug has shown safety and tolerability in three Phase 1 studies and has been the first TSLP inhibitor to maintain target engagement and inhibit disease-related biomarkers up to 24 weeks post-dose in asthma patients.
The company's primary focus is on asthma, a prevalent condition affecting an estimated 350 million individuals globally, with a significant portion suffering from severe asthma. CRSwNP, which often co-occurs with asthma, is a chronic upper airway disease that affects the sinuses and nasal passages. Upstream Bio is leveraging its expertise to develop verekitug as a treatment that could alleviate the impact of inflammatory and allergic diseases on patients and their families.