Sign in Subscribe
Diseases

Upstream Bio Initiates Phase 2 Clinical Trial for Verekitug in Moderate-to-Severe COPD

Strategic Insights

— 2 min read

The first patient has been dosed in Upstream Bio's Phase 2 clinical trial, VENTURE, evaluating the efficacy and safety of verekitug in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD). This trial expands the global development program for verekitug into a third indication, following ongoing Phase 2 studies in chronic rhinosinusitis with nasal polyps (CRSwNP) and severe asthma. Verekitug, a novel antibody antagonist of the Thymic Stromal Lymphopoietin (TSLP) receptor, has demonstrated potential in preclinical and early clinical studies in asthma, suggesting it may have a positive impact on COPD treatment with less frequent dosing and differentiated efficacy compared to currently approved biologic therapies.

Key Takeaways:

  • Upstream Bio initiated the VENTURE Phase 2 clinical trial to evaluate the efficacy and safety of verekitug in patients with moderate-to-severe COPD, enrolling approximately 670 adults.
  • The trial will assess the annualized rate of moderate or severe COPD exacerbations as the primary endpoint, along with changes in participants' day-to-day symptoms, measures of lung function, and other secondary endpoints.
  • Verekitug, a monoclonal antibody targeting the TSLP receptor, has been shown to inhibit proinflammatory signaling initiated by TSLP and demonstrated high occupancy of the TSLP receptor and potent inhibition of TSLP signaling in preclinical studies.
  • The Company completed enrollment in Phase 2 trials in CRSwNP and severe asthma in January and June 2025, respectively, with top-line data expected in the third quarter of 2025 and the first quarter of 2026, respectively.
  • COPD is a chronic inflammatory disease affecting the airways, causing episodic exacerbations and structural changes in the lungs, with no cure and limited available treatments.
  • The prevalence of COPD is estimated to be higher than the reported 6.5% of the adult population in the US, with approximately 3.5 million deaths worldwide in 2021.
  • The Company's team is working to maximize verekitug's unique attributes to address the substantial unmet needs for patients with severe respiratory disorders.

Statistics:

  • Approximately 14.2 million Americans reported being diagnosed with COPD in 2021, with 670 patients enrolled in the VENTURE clinical trial.
  • The VENTURE trial will evaluate the efficacy and safety of verekitug in patients with moderate-to-severe COPD, aiming to assess the annualized rate of moderate or severe COPD exacerbations as the primary endpoint.
  • 50% reductions in fractional exhaled nitric oxide (FeNO) and blood eosinophils were observed in patients with asthma treated with verekitug in the Phase 1b MAD trial.
  • The Company has designed the VENTURE trial using endpoints that, pending interactions with regulatory authorities, could produce data to support submissions for product approval.

Sources:

  • GLOBE NEWSWIRE, "Upstream Bio Initiates Phase 2 Clinical Trial for Verekitug in Moderate-to-Severe COPD" (July 08, 2025)
  • , "VENTURE Phase 2 Clinical Trial in COPD"
  • , "Phase 2 Clinical Trial for Verekitug in Patients with Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD)"

Read more