Unlocking Approval: Baldo Scassellati Sforzolini from Galderma in a Stimulating Dialogue Exchange with PharmaShots

Shots:

Galderma’s Nemluvio (nemolizumab) was recently approved by the US FDA for the treatment of adults with prurigo nodularis, following positive Phase III results from the OLYMPIA study.

Today at PharmaShots, we have Baldo Scassellati Sforzolini, Global Head of Research & Development at Galderma, to discuss the study’s design and the potential of Nemluvio in treating conditions like Atopic Dermatitis.
Nemluvio works by inhibiting IL-31 signalling, which plays a key role in driving various disease mechanisms in Prurigo Nodularis. It is now the second FDA-approved treatment for this condition

Saurabh: Prurigo nodularis is often seen as an underdiagnosed condition. From your experience, what makes diagnosing and treating this chronic skin disease particularly challenging? 

Baldo: Limited studies investigating the prevalence of prurigo nodularis as well as the lack of standardized classifications and understanding of its pathophysiology lead to prurigo nodularis being underrecognized and underdiagnosed. This results in poor disease management and suboptimal outcomes for patients. Symptoms of prurigo nodularis are driven by complex interactions between the skin, nerve, and immune cells, and disrupting this cycle through rapid, sustained itch relief is crucial to improving long-term outcomes.

Saurabh: With Nemluvio now under review by several regulatory authorities, like the EMA and Health Canada, how do you see it potentially impacting patients on a global scale? 

Baldo: Until the U.S. FDA’s approval of Nemluvio (nemolizumab), there was only one approved treatment for prurigo nodularis. We’re confident in the impact it will have for patients with prurigo nodularis who urgently need more treatment options.

Saurabh: The Phase III OLYMPIA trials showed impressive improvements in itches and skin nodules. Could you walk us through the key goals of the study, the primary and secondary endpoints that ultimately led to Nemluvio's approval? 

Baldo: The OLYMPIA program – the largest clinical trial program conducted in this condition to date – included two identically designed, pivotal phase III clinical trials, which enrolled 560 patients – OLYMPIA 1 and 2.

The trials met their primary and all key secondary endpoints. The primary endpoints were focused on clearance or almost-clearance of skin and reduction in itch intensity at Week 16. Key secondary endpoints measured the rapidity of reduction of itch intensity and improvements in sleep disturbance. The data show that nemolizumab provides significant and clinically meaningful improvements on itch, sleep disturbance and skin lesions, with rapid onset of action on itch – as early as Week 4.

56% and 49% of nemolizumab-treated patients achieved at least a four-point reduction in itch intensity, as measured by the peak-pruritus numerical rating scale and 26% and 38% of nemolizumab-treated patients reached clearance or almost-clearance of skin nodules at Week 16, as measured by the investigator’s global assessment scale, in OLYMPIA 1 and 2 respectively.

In addition, 41% of nemolizumab-treated patients in OLYMPIA 1 and 2 achieved at least a four-point reduction in itch intensity at Week 4 and 50% and 52% of nemolizumab -treated patients in OLYMPIA 1 and 2 respectively, achieved at least a four-point reduction in sleep disturbance at Week 16, as measured by the sleep disturbance numerical rating scale.

Saurabh: How do you think Nemluvio will change the SoC for Prurigo nodularis, especially for patients struggling with severe itch and sleep disturbance? 

Baldo: Currently, symptoms of prurigo nodularis are often managed with systemic or topical treatments which have shown limited efficacy as they do not address the underlying pathophysiology of the disease and can also carry the risk of adverse effects. Nemolizumab specifically inhibits IL-31 cytokine signaling, which is known to drive itch and is involved in inflammation, altered epidermal differentiation, and fibrosis (hardening of skin tissue) in prurigo nodularis.

Nemluvio is a first-in-class therapy with a unique mode of action that effectively targets the underlying disease mechanisms of prurigo nodularis by inhibiting IL-31 cytokine signaling. Nemluvio is also the first treatment for prurigo nodularis approved by the U.S. FDA that lists a peak-pruritus numerical rating scale score of <2 (meaning itch free or almost itch free) on its label. With itch often reported as the most burdensome symptom of prurigo nodularis, we’re confident in the impact it will have for patients with prurigo nodularis who urgently need more treatment options.

Saurabh: Besides Prurigo nodularis, Nemluvio is also being looked at for conditions like atopic dermatitis. Given its unique mechanism of targeting IL-31, are there any other future indications or expansions being explored? 

Baldo: The ARCADIA program, evaluating the efficacy and safety of nemolizumab in adolescent and adult patients with moderate-to-severe atopic dermatitis has been completed and, based on the positive results of the ARCADIA 1 and 2 trials, the U.S. FDA accepted for review our Biologics License Application, with a decision expected by the end of the year. We are currently awaiting decisions from several other regulatory authorities on our filing applications, including the European Medicines Agency, Health Canada, and via the Access Consortium.

We are currently assessing potential indications for other itch-related skin diseases, dedicating our efforts to exploring areas with unmet treatment needs where nemolizumab could have the greatest impact on patients.

Saurabh: Now that Nemluvio has FDA approval, what are Galderma’s next steps for bringing it to other markets and expanding its global reach? Since Nemluvio is already approved and marketed as Mitchga in Japan for several indications, how does Galderma plan to harness the global potential of Nemluvio in markets beyond Japan and Taiwan? 

Baldo: Our marketing authorization applications for nemolizumab in both prurigo nodularis and atopic dermatitis are under review by multiple regulatory authorities, including the U.S. FDA, the European Medicines Agency, Health Canada, and via the Access Consortium framework. Further submissions to other regulatory authorities will continue in the coming months.

We are fully committed to bringing nemolizumab to patients as soon as possible, once it has been approved for use.

Image Source: Canva

About the Author:

Baldo Scassellati Sforzolini

Baldo Scassellati Sforzolini is Global Head of Research & Development at Galderma, from July 2020. Baldo joined Galderma from Allergan where he was Senior Vice President, Drug Development Operations and Global Evidence & Value. Prior to this, he served as Allergan’s Senior Vice President, Clinical Development, Vice President and Head of Global Development at Bausch + Lomb, and Vice President Ophthalmology Development at Novartis. He has also held positions in global development at Pfizer and Pharmacia. Baldo holds an MD from the University of Bologna, a PhD in Neurosensory Science and Ophthalmology Residency from the Marche Polytechnic University, a diploma of Pharmaceutical Medicine from Cardiff University, and an MBA from Cranfield School of Management.