Connect Biopharma Shares Surge on Positive Phase 2 COPD Drug Data

Shares of Connect Biopharma Holdings (NASDAQ: CNTB) surged as much as 25% on Wednesday following the company's announcement of positive results from a Phase 2 trial of its drug candidate, rademikibart, for treating chronic obstructive pulmonary disease (COPD).

Key Trial Results

The Seabreeze STAT COPD study evaluated rademikibart in patients experiencing an acute exacerbation of the disease. According to the company, the drug demonstrated significant efficacy compared to a placebo over a one-month period when added to standard care.

Key findings from the 159-participant global study include:

• A 81% reduction in the rate of treatment failure.
• An 85% reduction in new moderate-to-severe COPD exacerbations.
• A 100% reduction in hospitalizations or emergency department visits for new acute COPD exacerbations.

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The trial enrolled patients with an eosinophil count of at least 300 cells/μL, a biomarker indicating a specific type of inflammation. The company also reported that rademikibart was well-tolerated, with a lower incidence of adverse events than the placebo group and no new safety signals observed.

Path to Phase 3

Rademikibart is a monoclonal antibody designed to block the functions of IL-4 and IL-13, two proteins involved in inflammatory diseases. Following these positive mid-stage results, Connect Biopharma stated it plans to engage with the U.S. Food and Drug Administration (FDA) to align on a Phase 3 clinical program for the drug as an add-on treatment for COPD.

This marks a critical step for the San Diego-based company as it seeks to advance its pipeline of treatments for inflammatory conditions. Connect Biopharma has already granted an exclusive license to Simcere Pharmaceutical for rademikibart in Greater China, a deal for which it is eligible to receive up to approximately $99 million in milestone payments.