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Upstream Bio Announces Phase 3 Development Plans for Verekitug
Upstream Bio announced its pivotal Phase 3 development plans for Verekitug in severe asthma and chronic rhinosinusitis with nasal polyps. Verekitug is the only known antagonist currently in clinical development that targets and inhibits the thymic stromal lymphopoietin receptor. Following productive End-of-Phase 2 meetings with the U.S. FDA, the company is moving quickly to initiate one placebo-controlled Phase 3 trial each in severe asthma and CRSwNP. Leveraging the data from its extensive development program to date, the company's goal is to deliver best-in-class efficacy with quarterly at-home administration for patients with severe asthma and CRSwNP, irrespective of biomarker status. The company plans to evaluate a single high-dose regimen of 400 mg, administered every 12 weeks, in broad and representative patient populations, with the intent to robustly demonstrate Verekitug's efficacy and safety profile in these diseases with substantial unmet medical need.
Upstream Bio to Initiate Phase 3 Trials for Severe Asthma in 2027
"We continued to make progress toward the initiation of our Phase 3 trials in severe asthma and CRSwNP in the first quarter of 2027. Our End-of-Phase 2 interactions with the FDA are on schedule, and we look forward to sharing more details about our Phase 3 development plans soon," said Rand Sutherland, Chief Executive Officer of Upstream Bio. "With more than 500 participants treated in verekitug clinical trials thus far, and with compelling Phase 2 results now demonstrated in both severe asthma and CRSwNP, we have built a substantial and consistent body of clinical evidence supporting verekitug's potential to deliver durable, best-in-class efficacy with convenient quarterly dosing. In addition, our CMC and device development efforts continue to advance, and we are working diligently to provide options for both at-home and in-office administration at launch."
Upstream Bio Presents New Verekitug Analysis at EAACI Congress
Upstream Bio presented new responder analyses from the Phase 2 VIBRANT trial of verekitug in participants with chronic rhinosinusitis with nasal polyps. The findings were presented during an oral session at the European Academy of Allergy and Clinical Immunology, EAACI, 2026 Congress in Istanbul, Turkey. As previously reported, verekitug administered every three months achieved a placebo-adjusted reduction in NPS of -1.95 at Week 24, after adjustment for concomitant rescue therapy with systemic corticosteroids. This improvement is nearly double the 1.0 point reduction generally considered clinically meaningful.
Upstream Bio Presents New Data from VIBRANT Trial
Upstream Bio presented new data from the Phase 2 VIBRANT trial evaluating verekitug in participants with chronic rhinosinusitis with nasal polyps. The data, presented in two posters at the American Thoracic Society 2026 International Conference in Orlando, FL, demonstrated the positive effect of verekitug in participants with CRSwNP and comorbid asthma, as well as its impact on type 2 inflammatory biomarkers in blood and nasal secretions. Approximately 60% of the 81 participants in the VIBRANT trial had comorbid asthma. Among participants with comorbid asthma, verekitug 100 mg administered every 12 weeks led to improvement in asthma symptom control at Week 24, with a placebo-adjusted least squares mean reduction in ACQ-6 of -0.9 compared with placebo-well above the minimal clinically important change in ACQ-6 of -0.5. Verekitug also led to improvements in NPS at Week 24 in participants with and without comorbid asthma, consistent with the previously reported VIBRANT top-line results. In participants with comorbid asthma, generally greater improvements were observed across sinonasal symptom measures, including nasal congestion score, total symptom score, difficulty with sense of smell and Lund-Mackay score, compared with participants without comorbid asthma. Among participants with comorbid asthma, verekitug reduced the need for rescue systemic corticosteroids or CRSwNP surgery by 83% compared with placebo. In a separate post hoc analysis, verekitug 100 mg administered every 12 weeks led to rapid and sustained reductions in key type 2 inflammatory cytokines, including IL-4, IL-5, and IL-13, in both blood and nasal secretions over 24 weeks of treatment with generally greater reductions observed in nasal secretions. Verekitug also reduced additional mediators of local inflammation and fibrotic activity, including periostin, thymus and activation-regulated cytokine, macrophage-derived chemokine, and eotaxin-3, shedding light on the mechanisms by which a thymic stromal lymphopoietin receptor blockade may benefit patients with inflammatory airway disease. Verekitug reduced blood eosinophils by 50% as early as Week 2, with reductions sustained through Week 24. Reductions in IgE were observed beginning at Week 4 and continued to decline through Week 24. The magnitude of IL-5 reduction in blood correlated with the magnitude of reduction in blood eosinophils following verekitug treatment, VIBRANT was a Phase 2 global, randomized, double-blind, placebo-controlled, parallel group clinical trial that evaluated the efficacy and safety of verekitug over 24 weeks in 81 adults with CRSwNP. Upstream Bio designed the VIBRANT trial using endpoints that, pending interactions with regulatory authorities, could produce data to support submissions for product approval. The Company plans to initiate dosing in Phase 3 registrational trials in both CRSwNP and severe asthma in the first quarter of 2027.
Upstream Bio CEO Reports Strong Progress on Verekitug Clinical Programs
"We continue to make strong progress advancing our clinical programs in severe asthma and CRSwNP to position verekitug as a uniquely differentiated treatment option for these diseases," said Rand Sutherland, CEO of Upstream Bio. "We are working diligently to deliver best-in-class efficacy with convenient quarterly at-home dosing, a profile that we believe will advance the standard of care for patients and maximize the potential commercial value of verekitug. We are continuing to prepare for our End-of-Phase 2 meetings with the FDA, which we expect to occur in mid-2026, and we remain on track to initiate Phase 3 dosing in both severe asthma and CRSwNP in the first quarter of 2027."
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