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Expert Interview

Slingshot members are talking to an expert! The topic is:

Evaluating the Breakthrough in Chronic Spontaneous Urticaria Treatment: A Deep Dive into Celldex Therapeutics' Barzolvolimab CDX-0159 Phase 2 Study

Ticker(s): CLDX

Who's the expert?

Institution: Allergy Specialists

  • Board certified Internist and Allergist in private practice in Dallas, Texas treating adults and children with allergic diseases and asthma. 
  • Clinical Professor of Internal Medicine at the University of Texas Southwestern Medical School in Dallas and teaches at Parkland Memorial and Presbyterian Hospitals in Dallas. 
  • Follows 140 type 1 and 2 patients with HAE.
  • Member of the U.S. Hereditary Angioedema Association and on the panel responsible for the HAWK, ICON and WAO hereditary angioedema consensus documents.

Interview Questions
Q1.

Considering the rapid onset of action within 2 weeks and sustained activity observed in the study, how does barzolvolimab's efficacy and speed of response compare to current CSU treatments?

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Q2.

With the majority of study participants having severe disease (UAS7≥28), what is the significance of barzolvolimab's efficacy in this particular patient group?

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Q3.

How did the efficacy of barzolvolimab vary across the different dosing regimens (75 mg Q4W, 150 mg Q4W, 300 mg Q8W), and what implications does this have for personalized treatment strategies?

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Q4.

In the study, barzolvolimab showed similar improvement in patients experienced with/refractory to omalizumab and omalizumab-naïve patients. How does this highlight the drug's unique mechanism of action?

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Q5.

Could you elaborate on the safety profile of barzolvolimab, particularly focusing on the observed adverse events like hair color changes and neutropenia?

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Q6.

What insights can you provide regarding the responder analyses, particularly the percentages of patients achieving complete control (UAS7=0) and well-controlled states (UAS7≤6)?

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Q7.

Given the 52-week results are anticipated later this year, what are your expectations regarding the long-term efficacy and safety of barzolvolimab in CSU management?

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Q8.

How might the introduction of barzolvolimab reshape the treatment landscape for chronic spontaneous urticaria, especially for patients with antihistamine-refractory or omalizumab-refractory disease?

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Q9.

What other indications do you think mast cell depletion would work in? Can you speak to the level of unmet need in food allergy and prurigo nodularis?

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