Nemolizumab is a first-in-class investigational monoclonal antibody directed against the IL-31 receptor alpha that blocks signaling from IL-31.

Galderma’s nemolizumab performed well in Prurigo Nodularis (PN).

Nemolizumab is a first-in-class investigational monoclonal antibody directed against the IL-31 receptor alpha that blocks signaling from IL-31.Nemolizumab is an investigational drug and Galderma has not received approval for any indication in any country. Nemolizumab was granted Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA) in December 2019 for the treatment of pruritus associated with prurigo nodularis, a status reconfirmed in February 2023.

In the phase III OLYMPIA 2 trial, nemolizumab monotherapy met all primary and key secondary endpoints and demonstrated significant improvements on itch, skin clearance and sleep disturbance compared with placebo in adult patients with prurigo nodularis.

 The results were presented as a late-breaking presentation at the 2023 American Academy of Dermatology (AAD) Annual Meeting 

Fully 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, the study showed. In addition, 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.

Key secondary endpoints showed rapid onset of action and significant improvements in itch and sleep disturbance (p<0.0001) as early as week 4.

More than 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).

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)

The safety profile was consistent with the phase II trial results

"The results confirm the potential of this every four weeks injectable monoclonal antibody targeting the IL-31 receptor alpha, with rapidly acting effects on itch and sleep disturbance, and subsequent improvement of skin lesions,” says Shawn Kwatra, MD, an associate professor of dermatology at Johns Hopkins University in Baltimore.