The medical landscape for chronic rhinosinusitis is rapidly advancing, with new treatments offering hope for improved quality of life for patients. As pharmaceutical companies race to develop effective therapies, recent clinical trials are shedding light on promising solutions.
Upstream Bio Inc. (NASDAQ:UPB) on Tuesday shared topline results from the Phase 2 VIBRANT trial evaluating verekitug in participants with chronic rhinosinusitis with nasal polyps (CRSwNP).
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Over the 24-week treatment period, verekitug, dosed at 100mg every 12 weeks, met the primary endpoint and key secondary endpoints, demonstrating statistically significant and clinically meaningful reductions in both endoscopic nasal polyp score (NPS) and nasal congestion score (NCS), with a generally well-tolerated safety profile consistent with previous studies.
Treatment with verekitug also resulted in a significant reduction in the need for surgery or systemic corticosteroids.
The trial met its primary endpoint, demonstrating a statistically significant and clinically meaningful, placebo-adjusted reduction in NPS of -1.8 (p<0.0001) at Week 24 compared with baseline. The trial also showed a meaningful placebo-adjusted reduction from baseline in the patient-reported NCS, a key secondary endpoint, by -0.8 (p=0.0003).
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Significant improvements were also observed in other key secondary endpoints, including sinus opacification as measured by the Lund-Mackay score, reduction in the need for either systemic corticosteroids or nasal polyp surgery, and total symptom score (TSS).
Verekitug was generally well tolerated, demonstrating a favorable safety profile consistent with previous studies, with no SAEs observed.
The Food and Drug Administration (FDA) accepted for review GSK plc's (NYSE:GSK) marketing application for depemokimab in two indications, including CRSwNP. The Prescription Drug User Fee Act (PDUFA) date is December 16, 2025.
In June, Lyra Therapeutics, Inc. (NASDAQ:LYRA) released results from the ENLIGHTEN 2 Phase 3 trial of LYR-210 in adult patients with Chronic Rhinosinusitis (CRS).
The ENLIGHTEN 2 trial met its primary endpoint, with LYR-210 demonstrating statistically significant improvement compared to sham control in a composite of the three cardinal symptoms (3CS) of CRS (nasal obstruction, nasal discharge, facial pain/pressure) at week 24 (p=0.0078) in patients without nasal polyps.
UPB Price Action: Upstream Bio shares were up 3.56% at $17.73 at the time of publication on Tuesday. The stock is trading within its 52-week range of $5.14 to $29.45, according to Benzinga Pro data.
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