Creabilis, a clinical stage European biotechnology firm, has treated the first patients in its Phase IIb study of its lead product, CT327 (a TrkA kinase inhibitor), for patients with atopic dermatitis (AD).
The Phase IIb trial of CT327 is a multi-centre, randomised, double-blind, placebo-controlled study carried out on adult and adolescent patients older than 12 years with mild to moderate AD and at least moderate pruritus.
According to the company, the primary endpoints of the trial will analyse pruritus using a visual analogue scale (VAS), control of disease determined by Investigator Global Assessment (IGA) and also quality of life measures.
Some 210 patients would be enroled in the trial and results are scheduled to be released in the second quarter of 2014.
The company intends to bring CT327 closer to all patients suffering from this common disease by completing the Phase IIb trial based on the data secured from its previous Phase IIb study.
Creabilis CEO Eliot Forster said atopic dermatitis is a debilitating and poorly treated dermatological disorder often described as ‘itch with a rash’.
"We have a strong scientific rationale for the potential of CT327 as a novel treatment for chronic pruritus and have already demonstrated positive results in the clinic," Forster added.
In a previous Phase IIb study, CT327 showed a statistically significant and clinically meaningful reduction of pruritus and an improvement in psoriasis symptoms compared to placebo vehicle in psoriasis patients.
CT327 is believed to reduce the sensitisation of sensory neurons, a process that plays a pivotal role in the pathogenesis of pruritus by inhibiting TrkA kinase, the high affinity receptor for Nerve Growth Factor (NGF).
Creabilis used its proprietary Low Systemic Exposure (LSE) ‘topical-by-design’ technology to develop CT327.
In addition, the first-in-human studies of CT340, a potent narrow spectrum kinase inhibitor in development for the topical treatment of neuropathic pain, are expected to begin in 2013.
CT340 was also developed using LSE technology and is also IND-ready.
Creabilis CMO David Roblin said AD and related pruritus have a significant impact on patients’ and carers’ quality of life.
"Although some older treatments exist, there is a significant need for new therapies that are safe for long-term use," Roblin said.
"A new therapeutic agent like CT327 that specifically addresses pruritus, the cardinal symptom of the disease, would make a real difference to patients."
In dermatology, currently there are no approved therapies for the treatment of chronic pruritus.
Image: Atopy of the flexure crease of the elbow. Photo: courtesy of James Heilman, MD