UK life sciences group BTG has kicked off a clinical programme assessing the potential of its oral multiple sclerosis candidate BGC20-0134, having initiated dosing of healthy volunteers in a Phase I study.
The Phase I trial is randomised, double-blind and placebo-controlled in design, and will test the pharmacodynamic, pharmacokinetic and safety profiles of single and multiple oral doses of the agent, the group confirmed.
BGC20-0134 is essentially a structured lipid which works by restoring the balance of cytokines released by the body’s immune system that are thought to play a key role in the inflammation and destruction of nerve sheaths, which leads to neuronal damage and the onset of symptoms associated with the condition.
The company is certainly very hopeful of the agent’s potential; a pilot study of a prototype compound found that patients with the relapsing-remitting MS experienced decreases in both relapse rates and disability scores, as well as improvements in pain and cognitive endpoints, and preclinical models have shown the potency of BGC20-0134 to be three times that of the prototype.
Addressing an unmet need
The successful development of a drug to treat the condition would be a mighty boon for the firm, given that “the effective treatment of MS remains a significant unmet need”, according to Louise Makin, BTG’s chief executive officer. “We are pleased to have started clinical development of BGC20-0134”, she added, “which has the potential to address different forms of the disease and has the advantage of being an oral product.”
The new clinical programme is the latest in a stream of positive news flow for BTG over the recent months, both on the financial and pipeline side. Its first six months of the year 2007/8 saw revenues more than double to £47.6 million and, on the development front, the moved its migraine candidate BGC20-1531 into clinical trials, while results from Phase I trials of its sleep apnea (BGC20-0166) and head lice (BGC20-0582) treatments are expected sometime during the first quarter.
