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news.UK biopharmaceutical company Vernalis has reported striking weight loss in volunteers over 16 days in its single and multiple ascending dose study of its obesity drug candidate.
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The Phase I trial, which evaluated 66 obese and mildly obese volunteers, demonstrated clinically relevant reductions in body fat, energy intake and waist circumference. V24343 was generally well tolerated over the dose range, with no serious adverse effects.
Simon Sturge, CEO of Vernalis, stated: “We are very excited by these preliminary results which, if confirmed over longer studies, will be of significant benefit to overweight and obese patients. We stated from the outset of this trial that it is our intention to seek a partner for this program, a process which is enhanced by such promising data.”
Measures of efficacy were taken in the multiple ascending dose study, in which patients were treated at four daily dose levels of 5mg, 15mg, 50mg and 100mg. In this trial, there were beneficial effects of V24343 at all dose levels across multiple parameters, including weight loss, waist circumference, body fat and energy intake.
Average weight loss after 16 days was 0.5kg for placebo, 2.6kg for 5mg V24343 and 5.0kg for 100mg V24343.
According to the company, further trials will be required to evaluate the long-term safety and efficacy of this product in the treatment of obesity.