Overview
VEC-162 is a melatonin agonist entering Phase III trials for the treatment of insomnia. Compounds that selectively bind to melatonin receptors selectively are thought to be able to help treat sleep disorders, and additionally are believed to offer potential benefits in depression. We commenced a Phase III trial of VEC-162 for insomnia in February 2006. VEC-162 is also ready to commence a Phase II trial for the treatment of depression.
Limitations of current treatments
Industry sources estimate that of the 73 million U.S. adults who suffer from some form of insomnia, only approximately 11 million currently receive treatment. So many patients remain untreated because the drugs used to treat insomnia have inherent limitations that leave patients underserved. The key limitations include the potential for abuse, significant side effects and incomplete efficacy:
- Many of the products prescribed commonly for sleep disorders, including Ambien, Lunesta and Sonata, are classified as Schedule IV controlled substances by the DEA due to their potential for abuse, tolerance and withdrawl symptoms.
- Many drugs approved for and used in sleep disorders also induce a number of nuisance side effects beyond the more serious abuse and addiction effects associated with most approved products. These side effects include next-day grogginess, memory loss, unpleasant taste, dry mouth and hormonal changes.
- Many of the approved sleep drugs fail to provide benefit in the two most important ways to measure efficacy: sleep onset effect and sleep maintenance effect.
Potential advantages of VEC-162
We believe that VEC-162 may offer efficacy similar to the most efficacious of the approved sleep drugs, and that it may provide significant benefits to patients beyond those offered by the approved drugs. We believe that VEC-162 is unlikely to be scheduled as a controlled substance by the DEA, because Rozerem, which has a similar mechanism of action to VEC-162, was shown not to have potentional for abuse and was not classified as a Schedule IV controlled substance by the DEA. However, despite the fact that the drugs have a similar mechanism of action, our Phase II results demonstrate that VEC-162 has superior sleep maintenance to Rozerem. VEC-162 also appears to be safe, with no significant side effects or effects on next-day performance.
Overview of Phase II clinical results
We recently completed a radomized, double-blind, multi-center, placebo-controlled Phase II trial evaluating the effect of VEC-162 on healthy volunteers in a transient insomnia setting. This setting involved putting trial participants to bed five hours ahead of their regular sleep time.
A total of 37 healthy volunteers took one of four VEC-162 dosing groups (10, 20, 50, and 100 milligrams) or placebo. Patients took one oral dose 30 minutes before bedtime. The results of this trial demonstrated:
- Reduced duration of wake after sleep onset (WASO). There was a statistically significant (p<0.05) reduction in wake after sleep onset at 100 mg of 68.5 minutes, and a reduction in the duration of wake after sleep onset versus placebo of at least 36 minutes was observed at all doses. The effects were 36 minutes (10 mg) and 45 minutes (20 and 50 mg).
- Improved sleep efficiency. VEC-162 acheived statistically significant improvements in sleep efficiency vs. placebo at 50 mg (p<0.05) and 100 mg (p<0.02). Absolute improvement occurred at all doses with at least 12.5% greater sleep efficiency vs. placebo. Specific improvements were 12.5% (10 mg), 13.5% (20 mg), 15.4% (50 mg), and 18.1% (100 mg).
- Improved time to achieve persistent sleep. All patients experienced a reduction in time it took to achieve persistent sleep. The 10 mg dose improved 23.4 minutes vs. placebo (p<0.004), the 20 mg improved 10.1 minutes (not significant), the 50 mg improved 18.8 minutes (p<0.02), and the 100 mg dose improved 19.3 minutes (p<0.03).
- A placebo-like side effect profile. VEC-162 also demonstrated a strong safety profile, with no statistically significant side effects versus placebo and no impairment of next-day performance or mood.
Overview of Phase III clinical trial
We commenced our Phase III trial in February 2006 to evaulate the safety and efficacy of VEC-162 for the treatment of insomnia. The trial is a randomized, double-blind, placebo-controlled trial in which we expect to enroll approximately 400 healthy volunteers. The trial will measure sleep efficiency and time to fall asleep, as well as next-day performance and mood.