Rademikibart improves lung function in moderate to severe asthma
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Key takeaways:
- Rademikibart improved lung function and asthma control in adults with moderate to severe persistent asthma.
- The drug was “generally well tolerated” in this patient population.
Adults with moderate to severe persistent asthma receiving rademikibart every 2 weeks showed greater improvements in lung function at week 12 compared with patients assigned placebo, according to topline results from a phase 2b trial.
Asthma control also improved with both the 150 mg and 300 mg doses of rademikibart (CBP-201, Connect Biopharma) assessed in the trial at the 24-week mark, according to a press release from Connect Biopharma.
“The study showed that rademikibart improved lung function within 1 week of treatment initiation in patients with asthma — this relatively fast onset of action was sustained over time,” John V. Fahy, MD, professor of medicine in the division of pulmonary and critical care medicine at University of California, San Francisco (UCSF), where he directs the Severe Asthma Faculty Practice, told Healio.
“The overall efficacy and safety profile is very favorable and strongly supports further development,” Fahy added.
In a global, multicenter, randomized, double-blind, placebo-controlled phase 2b trial, researchers assessed 322 adults with moderate to severe persistent asthma to determine the efficacy and safety of rademikibart after 24 weeks.
Researchers evaluated two different doses of rademikibart — 150 mg (n = 106) and 300 mg (n = 108) — given every 2 weeks with a loading dose of 600 mg compared with placebo (n = 108).
By week 12, researchers observed large improvements in pre-bronchodilator FEV1 compared with baseline in the 150 mg rademikibart group (235 mL) and the 300 mg rademikibart group (283 mL). The placebo group only showed an improvement of 95 mL at this point, equating to significant differences in least square means for the 150 mg dose (140 mL; P = .005) and 300 mg dose (189 mL; P < .001) of rademikibart.
Notably, improvements in lung function appeared early on in treatment, with some showing up within the first week. According to the press release, patients in both rademikibart dose groups showed significant improvements through week 24.
Researchers also looked at pre-bronchodilator FEV1 changes at week 12 among patients with eosinophil levels of 300 cells/µL or more and found that both rademikibart dose groups had significant differences in least square means vs. the placebo group (150 mg rademikibart, 243 mL; 300 mg rademikibart, 328 mL; P < .001 for both).
After adjusting for placebo, researchers found significant absolute changes in Asthma Control Questionnaire scores between baseline and week 24 in both rademikibart groups (150 mg, –0.44; P < .001; 300 mg, –0.33; P < .01). Similar to the improvements in the lung function, improvements in asthma control occurred within 1 week of treatment.
At week 24, the number of total exacerbations was lower in the rademikibart groups vs. the placebo group (150 mg rademikibart, 11 exacerbations; 300 mg, 13 exacerbations vs. placebo, 25 exacerbations), which suggests a “strong trend” of fewer exacerbations with the drug, although the press release noted the trial wasn’t powered to assess this outcome. Rademikibart also may delay the time to first exacerbation, according to the release.
In terms of safety, patients from both rademikibart groups tolerated the drug and experienced comparable frequently reported treatment-emergent adverse events to patients from the placebo group, including COVID-19, cough, dyspnea and wheezing.
“If approved, and if phase 3 data confirm current phase 2-3 benefits seen, then rademikibart based on initial findings for asthma and atopic dermatitis could be a transformational therapy,” Edward Kerwin, MD, medical director of Clinical Research Institute in the Allergy and Asthma Center of Southern Oregon, told Healio. “It could be dosed monthly for patients with uncontrolled atopic diseases, and lead to a high level of disease control and stabilization with minimal side effect risk. Patients may tolerate this treatment very well as a monthly, at-home injected therapy.”
The release noted that detailed findings from this trial will be presented at a future medical congress, and Connect Biopharma is planning on discussing the drug’s phase 3 regulatory path with the FDA.