Upstream Bio’s verekitug has met both its primary and secondary endpoints in a clinical trial for patients with chronic rhinosinusitis with nasal polyps (CRSwNP).
During the Phase II VIBRANT study (NCT06164704), the monoclonal antibody (mAb) triggered a statistically significant 1.8-point placebo-adjusted reduction in endoscopic nasal polyp scores (NPS) from baseline. NPS is a key measure of disease severity in CRSwNP.
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Topline results also reveal that administration of the thymic stromal lymphopoietin (TSLP)-targeting biologic once every 12 weeks can reduce congestion scores by 0.8, while reducing the need for surgery or chronic corticosteroid use by 76%.
These trends were seen in patients who either had a history of systemic corticosteroid use or had previously undergone surgical treatment for the disease.
While the company’s stock dropped on market open, from $17.13 at market close on 29 August to $16.66 at market open on 2 September, there was an uptick after the markets opened, rising to $18.03.
Moving forward, Upstream’s CEO Rand Sutherland confirmed that the biotech will conduct a “longer trial” for verekitug in CRSwNP in a 2 September investor call – though he did not provide further details. However, the company noted that it would “further engage with global regulatory authorities” to discuss verekitug’s continued development.
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By GlobalDataUpstream CMO Aaron Deykin added that the company would consider exploring the efficacy of verekitug in a once every 24-week setting, though this will depend on the top-line results from the 24-week cohort of the Phase II VALIANT study (NCT06196879) in severe asthma.
Penetrating the CRSwNP market
Though the results of the VIBRANT study are promising, verekitug will enter a tough market, as there are currently three other biologics approved for this indication. This includes Regeneron and Sanofi’s Dupixent (dupilumab), as well as GSK’s Nucala (mepolizumab) and Novartis’ Xolair (omalizumab).
The best-selling of these drugs is Dupixent, which generated $14.1bn for Sanofi and Regeneron in sales last year, with analysts at GlobalData, parent company of Clinical Trials Arena, forecasting that the drug’s sales will soar to $25.3bn by 2031.
Meanwhile, AstraZeneca and Amgen are also looking to secure a label expansion for their TSLP blocker, Tezspire (tezepelumab-ekko), in CRSwNP after the positive results of the Phase III WAYPOINT trial (NCT04851964). If both drugs were approved, they would compete head-to-head for sales.
Though Tezspire has set a solid benchmark in terms of efficacy, Matthew Phipps, head of the biotech equity research team at William Blair, stated that this trial’s results “strongly support the ability of verekitug to be given at least once every four months, and show at least similar efficacy of Tezspire” in a research note.
This extended dosing period would dwarf Tezspire’s dosing pattern significantly, which requires administration once every four weeks to maintain a similar efficacy profile.
Though Phipps noted that the Phase II severe asthma trial will be of “greater importance for the perception of verekitug’s market potential”, he believes that investors will “want to own Upstream Bio going into the asthma results”.
