HAMPTON, N.J. - Celldex Therapeutics, Inc. (NASDAQ:CLDX) today announced positive results from a Phase 2 clinical trial for its drug barzolvolimab, showing significant effects in treating chronic inducible urticaria (CIndU), a condition characterized by hives triggered by external stimuli. The trial focused on two common forms of CIndU: cold urticaria (ColdU) and symptomatic dermographism (SD).
The study evaluated 196 patients who continued to experience symptoms despite antihistamine treatments. Barzolvolimab, a humanized monoclonal antibody targeting the receptor tyrosine kinase KIT, demonstrated a statistically significant complete response rate at Week 12 compared to placebo, as measured by the TempTest® for ColdU and the FricTest® for SD.
Patients were administered barzolvolimab subcutaneously at dosages of either 150 mg every four weeks or 300 mg every eight weeks, and their responses were compared against a placebo group.
The primary endpoint was the percentage of patients with a negative provocation test at Week 12, with barzolvolimab achieving 46.9% and 53.1% in the 150 mg and 300 mg dose groups for ColdU, respectively, and 57.6% and 42.4% for the same doses in SD.
The safety profile of barzolvolimab was favorable and consistent with prior studies, with the most common treatment-emergent adverse events being hair color changes and neutropenia. Neither of these side effects was associated with an increased rate of infections compared to the placebo group.
Celldex plans to advance barzolvolimab into Phase 3 registration development, with the full 12-week data set to be presented at a medical meeting in the fourth quarter of the year. The company aims to address the unmet need for effective treatments for patients with CIndU, who currently rely on antihistamines and avoidance of triggers.
The success of barzolvolimab in this Phase 2 trial marks a significant step towards providing a new therapeutic option for individuals suffering from chronic inducible urticarias, which affect approximately 0.5% of the population. Further details about the trial (NCT05405660) can be found on www.clinicaltrials.gov.
This report is based on a press release statement from Celldex Therapeutics, Inc.
In other recent news, Celldex Therapeutics has embarked on global Phase 3 trials for its drug candidate, barzolvolimab, aimed at treating adults with chronic spontaneous urticaria (CSU). The trials will evaluate the drug's efficacy and safety, with a primary focus on the reduction in urticaria activity. In parallel, Celldex has completed patient enrollment for its Phase 2 clinical trial of the same drug, targeting Chronic Inducible Urticaria (CIndU).
Analyst firm Stifel initiated coverage on Celldex with a Buy rating, highlighting the potential of barzolvolimab, which showed promising results in Phase 2 trials. Similarly, Wolfe Research assigned an Outperform rating to Celldex, indicating the company's potential attractiveness for mergers and acquisitions.
These are recent developments in Celldex Therapeutics' ongoing efforts to develop treatments for severe inflammatory and allergic diseases. The company's progress in these trials and positive analyst ratings underscore its commitment to advancing healthcare research and delivery. It's important to note that these updates do not predict the future performance of Celldex but provide insights into its recent activities and potential growth areas.
InvestingPro Insights
As Celldex Therapeutics (NASDAQ:CLDX) announces promising results from their Phase 2 trial for barzolvolimab, the financial metrics and analyst insights provided by InvestingPro paint a broader picture of the company's current market standing.
With a market capitalization of $2.77 billion, Celldex holds a significant position in the biotechnology industry. The company's commitment to innovation is underscored by its substantial revenue growth of 92.76% in the last twelve months as of Q1 2024, despite a quarterly dip of -83.87% in Q1 2024. This growth may reflect investor confidence in the company's pipeline and its potential to bring new treatments to market.
InvestingPro Tips suggest that Celldex has a stronger liquidity position, holding more cash than debt on its balance sheet, which is a positive signal for investors concerned about the company's financial resilience. Moreover, two analysts have revised their earnings upwards for the upcoming period, indicating a potential uptrend in the company's financial performance.
However, it is important to note that the company's gross profit margin stands at a negative 1923.62%, reflecting the high costs associated with drug development and the challenges faced in generating profit in the competitive biotech sector.
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