Biologic treatment for asthma and COPD

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Connect Biopharma Reports First Quarter 2025 Financial Results and Provides Business Update
Globenewswire· 2025-05-15 13:00
Core Viewpoint - Connect Biopharma is advancing its clinical development of rademikibart, a novel biologic treatment for asthma and COPD, with positive Phase 2 trial results and a strong financial position to support ongoing studies and operations [1][2][3]. Clinical Development - The company initiated Phase 2 Seabreeze STAT studies for rademikibart as an adjunct treatment for acute exacerbations in asthma and COPD, with topline data expected in the first half of 2026 [1][3]. - A positive Type C meeting with the FDA was completed, aligning on the Phase 2 study protocols [3]. - Rademikibart showed significant improvements in lung function, with a mean difference from placebo in forced expiratory volume of +420 mL in patients with eosinophilic-driven asthma after 24 weeks [3]. Financial Performance - For the three months ended March 31, 2025, the company reported a net loss of $10.3 million, or $0.19 per share, compared to a net loss of $8.7 million, or $0.16 per share, for the same period in 2024 [8][13]. - Research and Development expenses decreased to $6.6 million from $8.7 million year-over-year, while General and Administrative expenses increased to $4.8 million from $4.0 million [8][13]. - As of March 31, 2025, cash, cash equivalents, and short-term investments totaled $84.0 million, expected to fund operations into 2027 [8][15]. Upcoming Events - The company has four posters accepted for presentation at the American Thoracic Society (ATS) 2025 International Conference, supporting the development of rademikibart for patients with moderate-to-severe asthma or COPD experiencing acute exacerbations [2][3][8].
Connect Biopharma Announces Publication of Positive Data from Global Phase 2 Trial of Rademikibart in Patients with Moderate-to-Severe Uncontrolled Asthma
Globenewswire· 2025-03-31 20:05
Core Insights - Connect Biopharma announced positive results from the global Phase 2 trial of rademikibart, indicating its potential as a novel biologic treatment for asthma and Type 2 inflammation, with significant improvements in lung function and reduced exacerbation rates [1][6]. Group 1: Trial Results - The Phase 2 trial involved 322 adult patients with moderate-to-severe uncontrolled asthma, randomized to receive either rademikibart (150 mg or 300 mg every 2 weeks after a 600 mg loading dose) or placebo for 24 weeks [2]. - Significant improvements in forced expiratory volume in one second (FEV1) were observed, with a mean difference from placebo of +420 mL in patients with eosinophils ≥300 cells/µL at baseline [5]. - Rademikibart demonstrated rapid onset of action, with improvements in FEV1 beginning at week one and sustained through 24 weeks [1][2]. Group 2: Safety and Efficacy - Rademikibart was generally well-tolerated, with most treatment-emergent adverse events being mild or moderate, and no serious adverse events related to the treatment [5]. - No eosinophilia-related adverse events were reported, contrasting favorably with other biologics like dupilumab, which had a 13% incidence in similar patient subgroups [5][6]. - The treatment resulted in fewer acute exacerbations compared to placebo, with 24 events in 214 patients receiving rademikibart versus 26 events in 108 patients receiving placebo [5]. Group 3: Future Prospects - Based on the trial data, Connect Biopharma received FDA agreement to advance rademikibart into Phase 3 trials for asthma maintenance treatment [3]. - The company sees significant opportunities to study rademikibart in the critical period following acute exacerbations of asthma or COPD, where current therapies have not been systematically studied [6]. - Rademikibart has the potential to address the needs of approximately 1 million asthma patients and 1.3 million COPD patients in the U.S. who experience acute exacerbations annually [7].