CNTB News & Events

Connect Biopharma announced results from a Phase 3 52-week study in patients with moderate-to-severe atopic dermatitis conducted by the company's partner in China, Simcere Pharmaceutical, which were presented during the late-breaking research session of the 2026 American Academy of Dermatology annual meeting on March 28 in Denver, Colorado. The 52-week Phase 3 study was a double-blind, placebo-controlled trial in China that enrolled 259 adolescent and adult patients with moderate-to-severe AD, who were randomized to receive rademikibart 300 mg administered every two weeks or placebo via SC injection during a 16-week induction phase, followed by a 36-week maintenance phase in which patients randomized to rademikibart continued on rademikibart and patients randomized to placebo switched to rademikibart. At Week 52, rademikibart demonstrated strong maintenance of response among Week 16 responders, with continued improvement across all key efficacy endpoints. Rademikibart demonstrated: 96.6% of patients achieved a 75% reduction from baseline in the Eczema Area and Severity Index; 87.1% of patients achieved a score of 0 or 1 with at least a 2-point reduction on the Investigator's Global Assessment of Atopic Dermatitis and 85.3% of patients achieved a 90% reduction from baseline in the Eczema Area and Severity Index. Rademikibart was well tolerated with safety similar to placebo at 16 weeks and lower conjunctivitis than other agents in the class. No significant, drug-related safety issues observed in over 1,500 participants receiving rademikibart in completed studies across indications.

Connect Biopharma highlighted new mechanism of action data for rademikibart and outlined its priorities for 2026. Development Highlights: New mechanism of action data supports the use of rademikibart in combination with standard of care beta-agonists to reverse acute exacerbations and for maintenance therapy in asthma and COPD; Initiated Phase 1b clinical pharmacology study with IV rademikibart to evaluate opportunity to reverse bronchoconstriction even more quickly than subcutaneous dosing; expect to report topline results in the first quarter of 2026; Recruitment of participants into the Phase 2 Seabreeze STAT asthma and Seabreeze STAT COPD studies evaluating the safety and efficacy of rademikibart as an adjunct treatment for acute exacerbations is ongoing with topline data from both studies expected in mid-2026.

Lake Street analyst Thomas Flaten initiated coverage of Connect Biopharma with a Buy rating and $9 price target. Shares have recently gained traction in the market in recognition of the upcoming Seabreeze STAT readouts and the upside they may deliver to shareholders, argues the analyst, who sees "significant headroom for shares beyond today" ahead of readouts due in the first half of 2026 and as the long-term potential of rademikibart "becomes more fully understood."