Dr. Barry Quart brings over 30 years of extensive experience serving in leadership positions in biotechnology and pharmaceutical companies and developing innovative pharmaceutical products. He has personally led several early-stage companies through late-stage clinical development, regulatory strategy, highlighted by nine U.S. Food and Drug Administration (FDA) approved drugs.

Dr. Quart was most recently CEO at Heron Therapeutics. He first served as CEO and Director starting in 2012, transitioned to President and CEO in 2019 and was named Chair of the Board in October 2020. At Heron, Dr. Quart oversaw the development and approval of four drugs: two drugs for CINV (CINVANTI® and SUSTOL®) and two acute care dugs (ZYNRELEF® and APONVIE®). Prior to Heron, Dr. Quart co-founded Ardea Biosciences, Inc. in 2006 and served as its President and Chief Executive Officer and Director from its inception through its acquisition by AstraZeneca PLC in 2012. At Ardea, Dr. Quart invented and oversaw the development of a drug for gout (ZURAMPIC®), as well as the design and development of a series of MEK inhibitors for cancer licensed to Bayer AG. Dr. Quart currently serves on the Board of Directors of Kiniksa Pharmaceuticals. He is the inventor of 18 U.S. patents and an author on 75 publications and abstracts. Dr. Quart received his Pharm.D. from the University of California, San Francisco.

Connect Biopharma is a clinical-stage biopharmaceutical company focused on advancing treatments for inflammatory diseases. Your lead candidate, rademikibart, is a next-generation anti-interleukin-4-receptor alpha for asthma and chronic obstructive pulmonary disease (COPD). Can you describe the underlying science and what differentiates this approach from currently approved biologics and competitors?

Rademikibart is Connect’s lead candidate for the treatment of autoimmune and inflammatory diseases. It is a human monoclonal antibody that targets the interleukin-4 alpha receptor (IL-4Rα), which is a common subunit for IL-4 and IL-13 receptors. These cytokines, IL-4 and IL-13, are central to the type 2 helper T cell (Th2) inflammatory pathway and drive several inflammatory conditions and diseases. Scientific evidence indicates that dual inhibition of IL-4 and IL-13 is required to achieve the desired efficacy in Th2-mediated diseases.

Rademikibart binds to a distinct and unique epitope in IL-4Rα that prevents the receptor from interacting with other receptor subunits that ultimately give rise to Th2-mediated diseases such as asthma. Rademikibart’s unique binding profile provides the molecular basis for important clinical differentiation: rapid onset of action with more pronounced improvement in airway function than observed with other biologics and an improved safety profile with none of the hyper-eosinophilia observed with dupilumab, the first IL-4R directed antibody approved for asthma and COPD.

The need for novel therapies to address acute exacerbations of asthma and COPD remains a critical need. Can you explain the significance of rademikibart’s potential in addressing this unmet need and why this is an area of focus? 

Unlike other biologic therapies, which typically can take weeks (and in some cases months) to achieve symptom improvement, rademikibart has demonstrated significant improvement in airway function in asthma patients within 24 hours. Moreover, this clinical effectiveness has been sustained for up to 24 weeks with an improved safety profile compared to dupilumab.

Acute exacerbations of inflammatory diseases represent a large, unmet need with no approved biologic therapies currently available. While existing, approved biologics have proven effective in maintenance therapy, they do not address the urgent therapeutic gap for acute exacerbations. Data suggest that rademikibart has the potential to meet this unmet gap by providing rapid and meaningful relief for the millions of individuals annually affected by exacerbations of asthma and chronic obstructive pulmonary disease (COPD).

There have been some recent setbacks in the asthma treatment landscape, including some high-profile clinical trial failures. Rademikibart has demonstrated encouraging safety and efficacy in moderate-to-severe uncontrolled asthma, as recently published in the American Journal of Respiratory and Critical Care Medicine. Can you talk more about the key takeaways from the study? 

In March, Connect announced the publication of positive results from its global Phase 2 trial of rademikibart, reinforcing its potential as a novel biologic treatment for patients with asthma and Type 2 inflammation.

The study demonstrated clinically meaningful and statistically significant improvements in lung function based on the primary endpoint (forced expiratory volume or FEV₁), with a rapid onset of action observed at one week and sustained efficacy through 24 weeks. Patients receiving rademikibart also experienced a clinically important reduction in acute exacerbations compared to patients receiving placebo treatment. Additionally, the treatment was well-tolerated, with no serious treatment-emergent adverse events related to rademikibart.

You recently announced a positive Type C meeting with the U.S. Food and Drug Administration (FDA) for rademikibart. Could you share the significance of this regulatory interaction and how it impacts the next steps toward potential approval?

In April, we announced positive feedback from our Type C meeting with the FDA’s Division of Pulmonology, Allergy, and Critical Care, in the Office of Immunology and Inflammation.

Following productive discussions with the FDA, we reached alignment on the design of our parallel Phase 2 clinical trials evaluating rademikibart in patients experiencing acute exacerbations of asthma (Seabreeze STAT Asthma Study; NCT06940141) or COPD (Seabreeze STAT COPD Study; NCT06940154), which are underserved therapeutic areas where no biologic therapies have been approved or systematically studied to-date. We have recently initiated parallel Phase 2 clinical trials in both asthma and COPD. The Seabreeze STAT Asthma Study builds on the positive results from the global Phase 2 study of rademikibart in patients with moderate-to-severe uncontrolled asthma, as published in a peer-reviewed journal. The Seabreeze STAT COPD Study was initiated following a successful post-hoc analysis of COPD-like patients from the previously completed global Phase 2b asthma study. We anticipate reporting top-line results from both asthma and COPD studies in the first half of next year.

Looking ahead, our goal is to generate a robust dataset that demonstrates both the clinical and health economic benefit of rademikibart in this untapped space, ultimately supporting engagement with a large commercial partner.

Connect Biopharma is presenting data at the upcoming American Thoracic Society (ATS) Annual Meeting, including Phase 2 results and the post-hoc analyses. What can we expect to learn from the presentations and how might this new data further position rademikibart in the competitive landscape? 

Connect will present four posters at the American Thoracic Society 2025 International Conference on May 18-19. The posters highlight our continued progress with advancing rademikibart in clinical development, showcasing positive efficacy and safety across clinical trials.

Most notably, rademikibart demonstrated rapid and substantial improvements in lung function as early as 24 hours post-treatment. These benefits were sustained through 24 weeks. In patients with type 2 inflammation-driven asthma in this study, acute exacerbations were significantly reduced by 63% to 73%.  Within the study of chronic asthma, there were patients with characteristics of COPD, another inflammatory-based respiratory disease. In these COPD-like patients, rademikibart was associated with sustained lung function improvement over a 24-week treatment period. These findings highlight rademikibart’s therapeutic potential in patients with type 2 inflammation-driven asthma and COPD and support clinical trials in patients experiencing an acute exacerbation of asthma and COPD. The two remaining posters being presented at ATS provide a molecular basis for the unique clinical attributes of rademikibart and discuss the unique safety profile of rademikibart. For more details on Connect’s presentations, please visit the ATS 2025 data news release here.

You bring over three decades of leadership in the biotechnology and pharmaceuticals industry, with a track record of advancing innovative therapies. Can you share key insights from your career journey, including your approach to navigating complex development paths and bringing novel treatments to patients? 

In June 2024, I assumed the position of Chief Executive Officer at Connect Biopharma, bringing over 30 years of experience in the biotechnology and pharmaceutical industries, where I held instrumental roles in the discovery, development, and successful approval of nine drugs. Prior to Connect, I have led two other San Diego-based public biotechnology companies and have previously held senior roles in several multinational pharmaceutical companies. I also currently serve on the Board of Directors at Kiniksa Pharmaceuticals, a biopharmaceutical company focused on discovering, acquiring, developing, and commercializing therapies that target immunological signaling pathways.

As an inventor on 18 U.S. patents and an author of more than 80 publications and abstracts, I have remained deeply engaged in driving innovation and advancing evidence-based approaches to therapeutic development.

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