UPDATED: Galderma drug passes PhIII in rare skin disease, setting the stage for approval request
Dermatology behemoth Galderma is one step closer to regulators’ doorsteps for a monoclonal antibody it licensed from Chugai Pharmaceutical after a Phase III readout Wednesday.
The former Nestlé Skin Health unit said that the drug, named nemolizumab, passed muster in one of two Phase III trials in the rare skin disease prurigo nodularis. The drug, tested on its own, was able to clear most skin lesions and reduce itching in patients with the rare skin disease.
The Cetaphil maker will package the results and submit to regulators once gathering data from the second Phase III study, CEO Flemming Ørnskov told Endpoints News in an email. The former Shire CEO declined to disclose when the second part of the OLYMPIA pivotal program would read out in the rare inflammatory disease, which is devoid of any approved therapies.
“If approved, nemolizumab would be a convenient therapy with a monthly injection as opposed to some of the existing biologic therapies which require biweekly injections,” the CEO said.
Galderma is also testing nemolizumab in atopic dermatitis. The Phase III AD trials, under the clinical program umbrella ARCADIA, are expected to complete in late 2022 or the first half of 2023, Ørnskov said. Another long-running biotech working to get into the AD space received FDA approval last December, as Leo Pharma won a nod for an IL-13-targeting drug, named Adbry.
After 16 weeks of treatment, 38% of patients treated with Galderma’s investigational med saw skin lesion clearance or almost-clearance as compared to 11% in the placebo group. On the itching improvement, Galderma’s med led to a four-point reduction or greater in itching in 56% of nemolizumab-treated patients compared to 21% in the control cohort.
All key secondary endpoints were also achieved, the Swiss dermatology company said Wednesday. Patients received two subcutaneous injections at baseline and then either one or two injections, depending on weight, every four weeks across 16 weeks.
Galderma is also investigating the drug in multiple mid- and late-stage trials in atopic dermatitis.
Originally developed by Chugai Pharmaceutical, the anti-IL-31 mAb received approval in Japan in March for treating pruritus (itching) associated with atopic dermatitis. Japanese biotech Maruho is marketing the drug as Mitchga. Maruho has Japan and Taiwan rights to the Chugai drug and Galderma has the exclusive global license elsewhere under a July 2016 deal, for which financials were not disclosed.
The Phase III results prop up the strategy behind Galderma’s increased focus on R&D since spinning out of Nestlé. With “disruptive potential,” nemolizumab is central to the company’s biologics future, Ørnskov said.
Editor’s note: This story was updated to clarify that Leo Pharma’s Adbry is an IL-13 and Galderma’s monoclonal antibody targets IL-31.