FDA greenlights Connect Biopharma’s asthma and COPD trials

SAN DIEGO - Connect Biopharma Holdings Limited (NASDAQ:CNTB), currently valued at $30 million and trading near its 52-week low of $0.55, has received the U.S. Food and Drug Administration’s (FDA) approval to proceed with Phase 2 clinical trials for its drug candidate rademikibart, targeting patients with moderate-to-severe asthma or chronic obstructive pulmonary disease (COPD) experiencing acute exacerbations. According to InvestingPro analysis, the company appears undervalued based on its Fair Value assessment. This development follows a Type C meeting with the FDA, where the need for new treatments in this area was acknowledged, given the lack of approved biologic therapies for such exacerbations.

The company plans to initiate two parallel randomized, double-blind, placebo-controlled Phase 2 trials in the second quarter of 2025. Each trial is set to enroll approximately 160 patients with uncontrolled, moderate-to-severe asthma or COPD with eosinophils ≥300 cells/µL who are experiencing an acute exacerbation. With a strong current ratio of 12.04 and more cash than debt on its balance sheet, the company appears well-positioned to fund these trials, though InvestingPro data indicates a rapid cash burn rate that investors should monitor. These studies aim to assess the efficacy of a single 600 mg subcutaneous dose of rademikibart over a 28-day period following an acute exacerbation.

Connect Biopharma’s CEO, Barry Quart, Pharm.D., expressed optimism about the trials, citing previous Phase 2 study results where rademikibart showed rapid improvement in pulmonary function. These trials are particularly significant as they address the high risk of recurrent exacerbations within the first 28 days after an initial episode, a period when patients are most vulnerable.

The decision to proceed with the trials is based on promising data suggesting rademikibart could provide rapid benefits to patients. Approximately 45% of patients receiving the current standard of care experienced treatment failure within 28 days following an acute exacerbation, highlighting the urgent need for better treatments.

Mario Castro, MD, MPH, a professor at the University of Kansas School of Medicine, supports the evaluation of rademikibart’s potential benefits following an acute exacerbation, given the lack of approved biologics for immediate symptom relief post-exacerbation.

Connect Biopharma expects to report data from both Phase 2 trials in the first half of 2026, with sufficient cash reserves to fund operations into 2027. The company is dedicated to transforming care for asthma and COPD and is positioning rademikibart as a next-generation, potentially best-in-class anti-interleukin-4-receptor alpha (IL-4Rα) antibody. Analyst price targets range from $6 to $8, suggesting significant upside potential, though the company’s next earnings report is due on April 17, 2025. InvestingPro subscribers have access to 13 additional exclusive insights about CNTB’s financial health and market performance.

This news is based on a press release statement from Connect Biopharma, and the company cautions that drug development is a high-risk venture, with early-stage clinical trial results not necessarily indicative of later-stage or larger-scale trials, nor do they guarantee regulatory approval.

In other recent news, Connect Biopharma Holdings reported its full-year 2024 financial results and announced plans for a Phase 2 trial of its drug rademikibart, targeting acute exacerbations in asthma or COPD, scheduled for the second quarter of 2025. H.C. Wainwright maintained a Buy rating on Connect Biopharma, with an $8.00 price target, reflecting confidence in the drug’s market potential. Analysts at H.C. Wainwright have projected global peak sales of rademikibart to reach $2.3 billion by 2038, factoring in a 25% probability. Meanwhile, Connect Biopharma received a Nasdaq notification regarding its stock price falling below the $1.00 minimum required for continued listing. The company has until September 22, 2025, to comply with Nasdaq’s minimum bid price rule by maintaining a $1.00 or higher bid price for ten consecutive business days. If compliance is not met, Connect Biopharma may qualify for an additional 180-day period to meet the requirements. Despite these challenges, the company’s development efforts continue, focusing on addressing the unmet needs in acute asthma and COPD exacerbations. The Nasdaq notice does not immediately affect the listing or trading of Connect Biopharma’s ADSs.

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