Nemolizumab Continues to Wow in PN

The phase III OLYMPIA 2 trial showed that nemolizumab monotherapy significantly and rapidly improved itch and skin lesions, with clinically meaningful improvements as early as week four.

Nemolizumab monotherapy significantly and rapidly improves itch and skin lesions in patients with prurigo nodularis, with clinically meaningful improvements seen as early as week four, according to results from the OLYMPIA 2 Trial, which appears in the New England Journal of Medicine.

Nemolizumab was well tolerated, and its safety profile was consistent with phase II trial results, the study showed.

Nemolizumab is a first-in-class investigational monoclonal antibody specifically designed to target the IL-31 receptor and inhibit IL-31 signaling. IL-31 plays a key role in multiple disease mechanisms in prurigo nodularis, including itch signaling, epidermal changes and fibrosis. 

The study included 274 adult patients with moderate to severe prurigo nodularis. Patients treated with nemolizumab monotherapy (without background topical corticosteroids or topical calcineurin inhibitors) showed clinically meaningful and statistically significant improvements in both primary endpoints, compared to placebo, after 16 weeks of treatment, specifically:

• More than twice as many nemolizumab-treated patients achieved an at least four-point improvement in itch intensity, as measured by the peak-pruritus numerical rating scale (PP-NRS), when compared to the placebo group.
• More than three times as many nemolizumab-treated patients reached clearance or almost-clearance of skin lesions, when assessed using the investigator’s global assessment score, compared to the placebo group.

The trial also met all key secondary endpoints confirming rapid responses on itch and sleep disturbance as early as week four, specifically:

• More than five times as many nemolizumab-treated patients achieved itch response when compared to the placebo group as measured by a four-point or greater reduction in PP-NRS score.
• More than eight times as many patients achieved a PP-NRS score of less than two, when compared to the placebo group. Results improved through to week 16.
• More than three times as many nemolizumab-treated patients demonstrated a four-point improvement in sleep disturbance, as measured by the sleep disturbance numerical rating scale, when compared to the placebo group. Results improved through to week 16.

“Chronic itch is by far the most burdensome symptom for patients with prurigo nodularis, and this is often poorly controlled,” says study author Shawn Kwatra, MD, a professor of dermatology at Johns Hopkins University and Director of the Johns Hopkins Itch Center in Baltimore. The fact that nemolizumab – by inhibiting IL-31 signaling – has the potential to provide a new treatment type that rapidly improves both itch and skin lesions is exciting news.”

Galderma is investigating the use of nemolizumab and has not received approval in any jurisdiction for any indication. Nemolizumab was granted Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA) in December 2019 for the treatment of itch associated with prurigo nodularis, a status reconfirmed in March 2023. 

Results from the phase III OLYMPIA 2 trial will be submitted to selected health authorities around the world.