Connect Biopharma plots phase 3 regulatory path after asthma asset hits mid-stage trial goals

A few weeks after selling off certain regional rights to monoclonal antibody (mAb) rademikibart, Connect Biopharma is back to share that the mid-stage asthma trial assessing the candidate has hit its main goal, demonstrating significantly improved lung function.

The topline results come from a phase 2b, double-blind trial conducted across five countries and 322 patients with moderate-to-severe persistent asthma. Patients were randomized into one of three groups, receiving either: 150 mg of rademikibart every two weeks with a loading dose of 600 mg; 300 mg every two weeks with a loading dose of 600 mg; or placebo.  

The trial met its primary endpoint of absolute change from baseline in pre-bronchodilator forced expiratory volume over one second—a way to determine the amount of air someone can exhale during a forced breath. Connect reported that both rademikibart doses significantly improved lung function over placebo at week 12. In fact, the improvements started as early as week 1 and lasted through 24 weeks of treatment.

The California-based biotech also reported a strong improvement in asthma control that became statistically significant starting at week 2 through week 24 for both dosing groups.

As for safety, the treatment was found to be generally well tolerated in both rademikibart arms, according to Connect.   

“Patients treated with rademikibart ... showed a trend towards meaningful, up to 50%, reductions in severe asthma exacerbations over the 24-week trial even without powering for this endpoint,” Edward Kerwin, M.D., medical director for the Clinical Research Institute, Allergy and Asthma Center of Southern Oregon, said in a Dec. 12 release. “Rademikibart looks like a potential transformational therapy that could benefit a substantial group of uncontrolled asthmatic patients who struggle globally for asthma control and freedom from exacerbations.”

Connect's next move is to set up a meeting with the FDA to discuss rademikibart’s phase 3 regulatory path.

But despite the trial win, investors seemed unimpressed, sending Connect’s stock down 11% to 80 cents as of 11:00 a.m. ET.   

The asthma data follows a separate data drop from a few weeks ago when Connect shared long-term results from an atopic dermatitis (eczema) trial of rademikibart. The 52-week follow-up built on initial 16-week results, which met the primary efficacy and safety goals of the trial and showed that the majority of initial responders to the mAb maintained their response, according to Connect.

The new results also come shortly after Simcere Pharmaceutical paid $21 million upfront with the potential for up to $120 million in biobucks for the rights to develop and commercialize rademikibart in Greater China. Under the agreement, Connect will wrap up rademikibart’s ongoing late-stage clinical trials for eczema occurring in China. Simcere will then be responsible for submitting a new drug application in the country, a move expected by the end of the first quarter of 2024.