Creabilis, a late stage European dermatology company with a focus on chronic pruritus (itch), today announces headline results of its Phase 2b trial with its lead product, CT327, in psoriasis patients. CT327 is a novel, topical, TrkA kinase inhibitor developed using Creabilis' LSE (Low Systemic Exposure) technology that creates 'topical-by-design' drugs.
Chronic pruritus is a debilitating symptom of many dermatological diseases and has a significant impact on quality of life, including sleep. It is the cardinal symptom in atopic dermatitis and a key symptom of psoriasis. No medicine is currently approved for chronic pruritus.
Patients receiving CT327 showed a statistically significant and clinically meaningful reduction in pruritus compared to blinded placebo vehicle. Pruritus was measured using a visual analogue scale (VAS), the accepted regulatory endpoint. The reduction from baseline in pruritus VAS reached 60% for CT327 compared to 20% for vehicle alone (p<0.05). A clinically meaningful reduction in pruritus (VAS ≥ 20mm) was seen in up to 79% of patients for CT327 compared to 36% for vehicle alone (p<0.05). At baseline, 69% of patients reported at least moderate pruritus (VAS > 40mm).
An improvement was also seen in the CT327 treated groups versus vehicle in mPASI (modified Psoriasis Area and Severity Index) in all patients. In patients with at least moderate pruritus at the start of the trial, significant reductions in mPASI were observed for CT327 compared to vehicle. There was no significant impact of any dose of CT327 on the IGA (Investigator Global Assessment) endpoint.
CT327 was safe and well tolerated with no site application reactions and no systemic exposure. Notably, patients on CT327 reported fewer adverse events and withdrawals due to pruritus than the vehicle treated patients.
Eliot Forster, CEO of Creabilis, said: "We are excited by the results seen in this Phase 2b trial. In particular, the benefits of CT327 in treating pruritus are very encouraging and take us closer to the market in an indication with no currently available treatments. We anticipate further clinical development activity, targeting pruritus, in the near term. CT327 will represent a breakthrough for patients and doctors alike, both of whom currently struggle to deal with this distressing condition."
David Roblin, CMO of Creabilis, said: "Pruritus is a debilitating yet under-recognised symptom in psoriasis and in other dermatological and systemic diseases. It has a significant impact on patients' quality of life and is currently poorly treated. There are no licensed products available, nor an established standard of care. There is a significant unmet need for a targeted treatment of chronic pruritus that combines efficacy with a good safety profile. In this study, up to 77% of CT327 treated patients had no or mild pruritus by the end of therapy. Combined with its outstanding safety profile, CT327 has the potential to provide a great benefit to patients."
About the Trial
The trial was a randomised, double-blind placebo controlled dose finding study of the efficacy and safety of a CT327 ointment at 0.05%, 0.1% and 0.5% w/w administered twice daily for eight weeks. One hundred and sixty patients with mild to moderate psoriasis were recruited. The study endpoints were IGA (Investigator Global Assessment), pruritus (VAS), mPASI and adverse event reports. Full data are expected to be presented at a scientific meeting later in 2013.
About Creabilis SA
Creabilis is a late clinical stage European biotechnology company with corporate and R&D functions spread across the UK and Italy.
Creabilis' primary focus is in chronic pruritus, a debilitating symptom of many dermatological diseases with a negative impact on quality of life. Chronic pruritus is an area of significant unmet need, with no medicine currently approved for its treatment.
Creabilis has delivered positive Phase 2b results for CT327 in the treatment of pruritus in psoriasis patients. CT327 is a novel, first-in-class, topically delivered TrkA kinase inhibitor. CT327 was developed using Creabilis' proprietary Low Systemic Exposure (LSE) 'topical-by-design' technology. LSE creates molecules optimized for topical applications. Planning for Phase 3 with CT327 is underway, with a clear route to market and an estimated >$800m in peak annual sales.
Creabilis' pipeline also includes CT340, a potent narrow spectrum kinase inhibitor in development for the topical treatment of neuropathic pain, an area of significant unmet medical need. Like CT327, CT340 was developed using the Company's Low Systemic Exposure (LSE) technology. CT340 is IND-ready and first-in-human studies will commence in 2013.
Creabilis is backed by highly respected life science investors Sofinnova Partners, Neomed and AbbVie Biotech Ventures Inc., and is led by an experienced Management team, with over 100 years of combined R&D experience in pharma and biotech, and over 20 drug approvals.