New Jersey-based biotech Celldex has canned its monoclonal antibody (mAb), barzolvolimab, in eosinophilic esophagitis (EoE) despite a Phase II trial meeting its primary endpoint.
In the Phase II EvolvE trial (NCT05774184), barzolvolimab met its primary endpoint and elicited a 72% decrease in peak mast cell (PMC) counts; however, it did not significantly alter Endoscopic Reference Scores (EREFS) in patients, with a p value of 0.95. EREFS is a key measure of disease severity in EoE.
Go deeper with GlobalData
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
Barzolvolimab also fell short in improving other key symptoms of EoE – including swallowing difficulties, as there were no significant changes in Dysphagia Symptom Questionnaire (DSQ) scores between placebo and treatment groups. While the KIT antagonist was able to reduce peak eosinophil counts, another indication of disease severity, this change was also not statistically significant.
Investors are not happy with these results, as Celldex’s stock has dropped 8% from $24.02 upon market close on 19 August to $21.96 at market open on 20 August.
The EvolvE trial’s outcome was unwelcome news for Celldex, leading to the drug’s termination in EoE, but the company’s President and CEO, Anthony Marruci, said it will continue to progress barzolvolimab in other indications in a 19 August statement.
“As we explore barzolvolimab’s full potential as a mast cell depleting agent, we are ultimately defining which diseases are mast cell driven,” he said.
US Tariffs are shifting - will you react or anticipate?
Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.
By GlobalData“We remain focused on advancing the deep pipeline for barzolvolimab, with enrollment ongoing across four studies – including two Phase III studies in chronic spontaneous urticaria,” Marruci added.
In an investor call, the CEO also divulged the company’s plans to explore barzolvolimab’s efficacy in new indications next year, stating that the company was awaiting further data release before beginning this process.
Dupixent to remain first choice in EoE
Until Celldex’s decision to discontinue barzolvolimab in EoE, the company was looking to enter a market dominated by Sanofi and Regeneron’s Dupixent (dupilumab), which was the first treatment available for the indication in the US in May 2022. It has since been approved in the paediatric population in January 2024.
The best-selling interleukin-4 (IL-4) and interleukin-13 (IL-13)-targeting mAb made Sanofi $14.1bn in 2024, with GlobalData’s analysts estimating that the drug’s sales will increase to $25.3bn in 2031 – pulling in numbers similar to Merck’s all-time best-seller Keytruda, which made the company $29.5bn in 2024.
GlobalData is the parent company of Clinical Trials Arena.
However, Sanofi and Regeneron could soon face competition from AstraZeneca and Amgen’s Tezspire (tezepelumab) in this indication, as the drug is currently being assessed in the Phase III CROSSING (NCT05583227) study, with a primary completion date set to 16 July 2026.
Having been previously approved in a range of respiratory, dermatological and ear, nose & throat disorders, Tezspire hit blockbuster status in 2024 – earning $1.2bn.
Takeda’s Eohilia (budesonide oral suspension) was also approved by the US Food and Drug Administration (FDA) in February 2024.
This competition is reflected in GlobalData’s market estimate for EoE, with analysts forecasting that the indication’s worth will grow to $1.2bn – primarily driven by the proposed introduction of late-stage candidates.
