Phase III OLYMPIA 2 trial of CIM 331 meets all primary endpoints in prurigo nodularis and data is presented at 2023 American Academy of Dermatology Annual Meeting.- Galderma

The phase III OLYMPIA 2 trial met all primary endpoints, showing nemolizumab monotherapy significantly improved pruritus (itch) and skin lesions compared with placebo in adult patients with moderate to severe prurigo nodularis. Results showed that: 56 percent of nemolizumab-treated patients achieved a response in itch intensity, as defined by an at least 4-point improvement in peak-pruritus numerical rating scale (PP-NRS) score, compared to 21 percent in the placebo group (p<0.0001). 38 percent of nemolizumab-treated patients reached treatment success in skin lesions, as defined by an investigator’s global assessment (iga) score of 0 or 1, compared to 11 percent in the placebo group (p><0.0001).></0.0001).></0.0001).>

Key secondary endpoints showed rapid onset of action and significant improvements in itch and sleep disturbance (p<0.0001) as early as week 4: over five times as many patients in the nemolizumab group vs placebo achieved significant and clinically meaningful improvement in itch intensity, as defined by a 4-point improvement in pp-nrs - (41.0% for nemolizumab vs 7.7% for placebo p><0.0001). nearly four times as many patients in the nemolizumab group versus placebo achieved significant and clinically meaningful improvement in sleep disturbance as measured by a 4-point improvement in sleep disturbance numerical rating scale (sd-nrs) - (37.2% for nemolizumab vs 9.9% for placebo p><0.0001). the safety profile was consistent with the phase ii trial results. the results were presented as a late-breaking presentation at the 2023 american academy of dermatology (aad) annual meeting by dr. shawn kwatra, associate professor of dermatology at the johns hopkins university school of medicine.></0.0001).></0.0001).></0.0001)>