Navigation Links
Creabilis Announces Headline Results of its Phase 2b Trial of Topical TrkA Kinase Inhibitor CT327
Date:5/10/2013

LUXEMBOURG, May 10, 2013 /PRNewswire/ --

Clinically and Statistically Significant Reduction of Chronic Pruritus (Itch) Seen in Psoriasis Patients

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.

For further information please contact:

Creabilis
Eliot Forster
info@creabilis-sa.com
Creabilis SA
15 rue Edward Steichen
L-2540 Luxembourg
                   
Citigate Dewe Rogerson
Chris Gardner or Nina Enegren
Tel: +44(0)20-7282-1050
E-mail: nina.enegren@citigatedr.co.uk



'/>"/>
SOURCE Creabilis SA
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Creabilis Awarded Prestigious European Commission FP7 Grant to Further Develop its LSE Topical-by-Design Technology
2. Omeros Announces $16.2 Million Registered Direct Offering of Common Stock
3. Allscripts announces first quarter 2013 results
4. The MED Group Announces New Agreement with CareCentrix Effective May 1, 2013
5. ASSA ABLOY Door Group Announces RF Shielding Openings
6. APHY announces new store openings as part of major expansion
7. NxStage Announces Second Quarter 2013 Investor Conference Schedule
8. Pro-Dex, Inc. Announces Fiscal 2013 Third Quarter Financial Results Conference Call and Webcast
9. Parametrics Medical, LLC Announces the Release of Their Coll-e-Strong Line of Soft Tissue Allografts
10. Sequenom Announces Participation At The Bank Of America Merrill Lynch Health Care Conference
11. GW Pharmaceuticals plc Announces the Closing of its Initial Public Offering on the Nasdaq Global Market
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/15/2017)... , Aug. 15, 2017 AccuGenomics, Inc., a ... , today announced that the company has provided an ... of North Carolina at Chapel Hill and to Qura ... to characterize and quantify HIV reservoir and viral expression ... intervention. The HIV Cure Center is a joint initiative ...
(Date:8/8/2017)... Aug. 8, 2017  BioLineRx Ltd. (NASDAQ/TASE: BLRX), a ... reports its financial results for the second quarter ended ... the second quarter 2017 and to date: ... development programs for the Company,s lead project, BL-8040: ... study with BL-8040 as novel stem cell mobilization treatment ...
(Date:8/7/2017)... 7, 2017  Diplomat Pharmacy, Inc. (NYSE: DPLO), the nation,s ... ended June 30, 2017.  All comparisons, unless otherwise noted, are ... Second Quarter 2017 Highlights include: ... million, an increase of 3.5% Total prescriptions ... margin of 7.5% versus 7.6% Gross ...
Breaking Medicine Technology:
(Date:8/18/2017)... ... August 18, 2017 , ... With over 16,000 ... bioidentical hormone replacement therapy and integrative medicine, has become a frontrunner for people ... such as menopause, andropause, thyroid disorder and adrenal insufficiencies. , Founded in ...
(Date:8/18/2017)... ... August 18, 2017 , ... 800response, the ... monitoring solutions, announced today the launch of a redesigned corporate website, 800response.com ... aesthetic, fully responsive design, and an enhanced search directory for businesses and advertising ...
(Date:8/18/2017)... (PRWEB) , ... August 18, 2017 , ... “Beyond Our ... fulfilled life. “Beyond Our Imaginations: The Infinite God” is the creation of published author, ... across the country. , Lawrence shares, “The problem with becoming a greater man of ...
(Date:8/18/2017)... ... 18, 2017 , ... “Prompted By Love”: a love story thrown into doubt ... Nettles. Author Mary P. Nettles has devoted her life to ministry since the ... lifelong desire to write was, however, not fulfilled until 2014 when "The Color of ...
(Date:8/17/2017)... ... August 17, 2017 , ... Shared leadership between physicians ... effective, very effective, or effective by 85% of respondents, according to the recent ... Reports are based on surveys of the NEJM Catalyst Insights Council, a qualified ...
Breaking Medicine News(10 mins):