SMT D002 is a medication which has potential for use as an acne treatment. In pill form it has reportedly proved very successful at reducing sebum production during clinical trials carried out by UK-based drug discovery company Summit Corporation PLC (AIM: SUMM). It is claimed to be safer than isotretinoin, which is currently the only medication accepted by the medical profession as being an effective sebosuppressive.
It has been referred to as a 'cure for acne' by the press. In fact it could not accurately be referred to as a cure, but at best an effective preventive treatment.
SMT D002 is a codename for an existing drug, used to treat a condition other than acne. For commercial reasons, Summit will not reveal its name or what it is currently used for. However, it is highly suspected that the drug is oxybutynin chloride, due to the discovery of US Pat. 12303680 - Filed Jun 7, 2007 - SUMMIT (CAMBRIDGE) LIMITED. Oxybutynin chloride is used to treat overactive bladder and urinary conditions. Additional evidence found at www.biomedcentral.com/content/pdf/cd-939533.pdf.
Two successful Phase I trials have been reported by Summit PLC. The first trial was described as a double-blind Phase I study in healthy volunteers using a single oral dose that showed up to a 70% reduction in sebum secretion. Prior to starting the second trial, Summit's director of clinical development Nigel Blackburn was quoted as saying:
The Phase I results are startlingly good. Reducing sebum production has been the "holy grail" of acne treatment for 30 years, and there has been little success aside from Roaccutane [isotretinoin] which has significant side effects.
At the doses we are looking at any side effects should be mild compared with those resulting from Roaccutane treatment'.
The second study was conducted using 18 healthy volunteers and examined the effect of repeat oral doses of SMT D002 over a four-day period. The key findings of the trial were reported as follows:
- 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
Summit PLC has indicated no plans to bring the pill form of SMT D002 to market, but has stated an intention to develop a topical formulation of the drug. The reason for developing a topical formulation has been given by Summit as 'to improve the way [it] is administered' and 'because it [is] likely to work more quickly'.
In May 2009 it was reported that, as part of a restructuring programme, a cross-licence agreement had been made with Orient Pharma Ltd:
Under the terms of the agreements, Orient gains exclusive development and
commercialisation rights in Asia Pacific and Australasia and will be responsible for all development, manufacturing and distribution costs associated with the products within its territories.
Summit retains the rights to the products in North America, Europe and the rest of the world and has rights to access data generated by Orient. This includes new formulations of the products and clinical trial results, which the Company can use to secure future commercial agreements within its territories.'
A press release dated May 2010 implies that Summit PLC is no longer committing significant resources to SMT D002:
Although Summit’s future research and development activities are now primarily focused on the SeglinTM
technology, [programmes including SMT D002] remain a potential source of future value upside that requires no investment from the Company.'