Connect Biopharma Holdings Limited (NASDAQ:CNTB) stock hit its 52-week low on Tuesday after releasing topline results from its global Phase 2 study evaluating rademikibart.
The clinical-stage biopharmaceutical company is testing the anti-interleukin-4-receptor alpha antibody as an add-on treatment for acute exacerbations in adult and adolescent patients facing asthma and type 2 inflammation.
Mixed Data
The Phase 2 Seabreeze STAT Asthma trial enrolled 160 patients. Researchers randomized participants evenly to receive either a 600mg subcutaneous dose of rademikibart or a placebo, alongside standard care.
Rademikibart decreased the treatment failure rate by approximately 66% over 28 days compared to the placebo. However, this primary endpoint missed statistical significance because the overall treatment failure rate landed lower than researchers initially projected.
The trial met its key secondary endpoint, demonstrating a statistically significant improvement in lung function.
Patients receiving rademikibart saw a 250 mL increase from baseline in post-bronchodilator forced expiratory volume at day seven.
In contrast, the placebo group experienced only a 120 mL increase. Connect Biopharma proposes using this metric as the primary endpoint for future Phase 3 trials.
Safety Data And Next Steps
Rademikibart demonstrated a favorable safety profile with no new safety signals.
The adverse event incidence remained low and comparable to the placebo. No adverse events caused study discontinuations in either group. Researchers noted just one serious adverse event in the treatment arm versus three in the placebo arm.
Looking ahead, Connect Biopharma expects to report topline data from its ongoing Phase 2 COPD study later this month.
The company also plans to meet promptly with the Food and Drug Administration to align on a Phase 3 program.
CNTB Price Action: Connect Biopharma Hldgs shares were down 32.46% to $1.16 at the time of publication on Tuesday. The stock is trading at a new 52-week low, according to Benzinga Pro data.
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