Chronic Pruritus of Unknown Origin (CPUO) is characterized by a persistent, chronic itch with an unknown cause and is associated with very high burden of disease due to severe itch, sleep deprivation and mental distress1
Galderma’s phase II study builds on emerging research that reinforces the role of IL-31 – a neuroimmune cytokine that is involved in driving itch – in CPUO1
Nemolizumab is a monoclonal antibody that specifically targets the IL-31 receptor alpha, inhibiting the signaling of IL-312
It is approved by multiple regulatory authorities for the treatment of moderate-to-severe atopic dermatitis and prurigo nodularis – conditions in which IL-31 plays a key role in driving itch, inflammation, epidermal dysregulation, and, in prurigo nodularis, fibrosis2-6
ZUG, Switzerland--(BUSINESS WIRE)--Galderma (SIX: GALD), the pure-play dermatology category leader, today announced the first patient enrollment for its phase II study investigating the efficacy and safety of nemolizumab in treating patients living with Chronic Pruritus of Unknown Origin (CPUO). The first patient of the trial – which is taking place in the United States – was enrolled at Dr. Vlada Groysman’s site in Birmingham, Alabama.
CPUO is an underdiagnosed condition defined as itch lasting for more than six weeks without an identified cause.1 It is a common condition and prevalent in nearly 30% of the elderly in certain populations, but despite its debilitating impact – with effects on sleep, mental health, and overall quality of life – there are currently no approved treatments.1,7
Nemolizumab is a monoclonal antibody that specifically targets the IL-31 receptor alpha, inhibiting the signaling of IL-31, a neuroimmune cytokine that plays a key role in CPUO by driving itch, its main symptom.1-4 This randomized, double-blind, placebo-controlled phase II study will determine the therapeutic potential of nemolizumab in adults with CPUO, to support progression to late-stage development.8
|
“We’re excited to launch this study exploring nemolizumab’s potential in patients with CPUO, many of whom have struggled for years without effective treatment options. Nemolizumab has shown outstanding efficacy in prurigo nodularis – a condition that shares important clinical and mechanistic features with CPUO – through its targeted inhibition of IL-31 signaling. With recent research further reinforcing IL-31 as a key driver of itch in CPUO, we’re hopeful that nemolizumab could offer meaningful relief to patients with this condition.” LEAD INVESTIGATOR, CHRONIC PRURITUS OF UNKNOWN ORIGIN PHASE II STUDY
|
