Positive Results from Phase I Clinical Trial of SMT D002 for the Treatment of Seborrhoea, a Primary Cause of Acne
* SMT D002 suppresses sebum levels by 90% in repeat-dose
* Results confirm potential of SMT D002 as a novel treatment for acne
OXFORD, April 15, 2008 - Summit Corporation plc (AIM: SUMM), a leading UK biotechnology company, today announces a positive outcome from its repeat-dose Phase I clinical trial of SMT D002, its candidate for the treatment of seborrhoea (excessive sebum production), a primary cause of acne.
The study was conducted in 18 healthy volunteers and examined the effect of repeat oral doses of SMT D002 over a four-day period. The key findings of the Phase I clinical trial are:
* Statistically significant levels of sebum suppression (primary endpoint) of 90% when compared to the placebo group (p=0.04) * SMT D002 proved to be safe with no serious or unexpected adverse side-effects reported * Sebum levels measured over six hours following treatment using a Sebumeter, an industry accepted method * Results from trial support a previous positive Phase I single-dose study conducted in nine volunteers
The results of this trial confirm the potential of SMT D002 as a new therapeutic agent for the treatment of seborrhoea in acne patients. Acne is a multi-billion dollar market and it is estimated that there are 54 million patients in the developed world with acne. Approximately eight million acne sufferers are also resistant to current topical retinoid acne treatments and therefore any new and effective treatment is anticipated to gain a sizeable share of this high-value market. In addition, seborrhoea is a non-motor symptom of Parkinson's disease that is estimated to affect a large proportion of patients.
Summit plans to develop a topical formulation of SMT D002 to further evaluate its efficacy in the treatment of acne and the Company is actively seeking a commercial partner to advance this candidate from the clinic through to the market.
SMT D002 has been developed using Summit's drug reprofiling expertise whereby the Company identifies and seeks to establish new therapeutic uses for existing marketed drugs with a long history of safe use.
Richard Storer, DPhil, Chief Scientific Officer of Summit commented: "The positive outcome of this Phase I clinical trial represents a major advancement of SMT D002 towards becoming a novel treatment for seborrhoea in acne and other indications including Parkinson's disease. The study showed clinically significant levels of sebum suppression and confirmed the positive data from an earlier clinical study. We believe that these clinical data significantly enhance the value of the SMT D002 programme and make it a very attractive partnering opportunity for development towards the market."
- ENDS - For more information, please contact: Summit plc Steven Lee, PhD, Chief Executive Officer Darren Millington, ACMA, Chief Financial Officer Richard Pye, PhD, Investor Relations +44 (0)1235 443951 + 44 (0)7825 313476 Citigate Dewe Rogerson Mark Swallow, PhD / Sylvie Berrebi / David Dible +44 (0)207 638 9571 Panmure Gordon Andrew Burnett / Rakesh Sharma (Corporate Finance) Ashton Clanfield (Corporate Broking) +44 (0)207 459 3600
About Summit plc Summit plc is a leading UK biotechnology company that discovers and develops proprietary new drugs. The Company's internal drug development programmes are underpinned by its advanced carbohydrate chemistry and zebrafish drug screening technology platforms, which it also provides on a collaborative or fee-for-service basis to the pharmaceutical industry. Summit plc has a broad range of drug discovery programmes in the clinical, pre-clinical and discovery stages of development, which target serious diseases with a high unmet medical need. These therapeutic areas include neurological disorders, anti-infectives, ophthalmic diseases and oncology. Summit plc's in-house drug development capabilities combine world-class expertise in both carbohydrate chemistry with high-volume, high-content screening using its proprietary zebrafish technologies. These whole organism screens have the potential to dramatically decrease the time and cost of drug discovery and development by delivering data that are highly predictive of the efficacy and toxicity of potential drug compounds in humans. The company listed on the AIM market of the London Stock Exchange in October 2004 - symbol: SUMM Further information about the company is available at www.summitplc.com
Sylvie Berrebi Account Manager Citigate Dewe Rogerson
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Posted: April 2008