Pharmaceutical Executive: What drew you to Connect Biopharma?
Barry Quart: I’ve spent more than three decades in leadership roles in the biotechnology and large pharmaceutical industries, including 16 years as CEO of publicly traded biotech companies. My career has spanned across a range of ventures, from small biotech enterprises to major pharma organizations. Early in my career, after spending some time at a large pharmaceutical company, I joined a small biotech where we developed what ultimately became a key component of the AIDS cocktail treatment. Later, another large pharmaceutical organization acquired that business, marking the beginning of a pattern throughout my professional career: switching between small biotech and well-established pharma giants.
How has treatment for COPD advanced in recent years?
Key Takeaways
- More than 1 million asthma patients and 1.3 million COPD patients visit an emergency department (ED) annually for exacerbations.
- Management of severe exacerbations and the prevention of hospital re-admissions remain challenging with approximately 50% of patients experiencing either a worsening of the exacerbation or another exacerbation within four weeks of discharge.
- There remains a significant unmet need for better treatment options to improve patient outcomes and reduce the burden on healthcare systems.
In both industry settings, I’ve led the development and registration of nine pharmaceutical products. Throughout my career, my focus has been on advancing promising therapies that address significant unmet needs, which led me to Connect Biopharma. I was particularly excited about CBP-201 (now called “rademikibart”) for the treatment of inflammatory diseases such as asthma and COPD (chronic obstructive pulmonary disease). In my view, despite its potential to benefit patients, Connect’s lead asset was undervalued, which ultimately motivated me to join the company.
PE: How does rademikibart solve unmet needs in asthma and COPD?
Quart: More than 1 million asthma patients and 1.3 million COPD patients visit an emergency department (ED) annually for exacerbations, which are called episodes or attacks, associated with an increase or worsening of respiratory symptoms, including coughing, wheezing, and shortness of breath.Most often, this can lead to hospitalization and can even cause death.
The current standard of care for treating exacerbations includes fast-acting inhaled bronchodilators and oral/IV corticosteroids. In more severe cases, additional interventions such as IV magnesium sulfate, heliox therapy, and noninvasive ventilation may be necessary. Intubation is only considered if patients do not respond to these initial therapies. Despite these options, management of severe exacerbations and the prevention of hospital re-admissions remain challenging with approximately 50% of patients experiencing either a worsening of the exacerbation or another exacerbation within four weeks of discharge. Currently, no biologic therapy has been approved or systematically studied for the treatment of acute exacerbations. There remains a significant unmet need for better treatment options to improve patient outcomes and reduce the burden on healthcare systems.
Rademikibart is a next-generation, human monoclonal IgG4 antibody directed against IL-4Rα, a common subunit for IL-4 and IL-13 receptors. Blockade of IL-4 and IL-13 binding to IL-4Rα results in inhibition of both IL-4 and IL-13 signaling, which ultimately reduces Th2-driven inflammatory responses, which is the underlying driver of inflammatory diseases such as asthma and COPD. Therefore, rademikibart has significant potential in treating patients suffering from acute exacerbations of asthma or COPD.
PE: What did the Phase 2 study results show for rademikibart?
Quart: The Phase 2 study evaluated the efficacy and safety of rademikibart therapy in adults with moderate-to-severe uncontrolled asthma. The results of the trial showed that rademikibart demonstrated a rapid onset of action with significant improvements in lung function observed at one-week post-treatment, which was then maintained through 24 weeks.Consistent with the improved airway function, patients receiving rademikibart had substantially fewer acute exacerbations than those receiving placebo. In addition, rademikibart was generally well-tolerated, with most side effects being mild or moderate.
The substantial increases in lung function, clinically meaningful decreases in exacerbations, and the favorable safety profile observed highlight rademikibart’s potential as a novel biologic treatment option for patients with chronic asthma and with other respiratory diseases with Type 2 inflammation, such as COPD. In particular, we believe that the unique clinical profile of rademikibart may provide significant immediate benefit for patients having an exacerbation and continue to benefit patients in the four weeks following an acute exacerbation of asthma or COPD, a vulnerable period at which patients are prone to experience another exacerbation.
PE: What are Connect Biopharma’s future plans?
Quart: We recently announced the initiation of two Phase 2 studies evaluating rademikibart as an adjunct treatment for acute exacerbations in asthma and COPD. Based on our data published in the American Journal of Respiratory and Critical Care Medicine, which was presented at the American Thoracic Society 2025 International Conference, we believe rademikibart holds significant potential as a promising treatment for patients suffering from acute exacerbations of certain inflammatory diseases. Because of this, we are well-positioned, well-capitalized, and look forward to sharing topline data from both studies in the first half of 2026.
