Ardana’s flagship product Teverelix LA has moved a step closer to Phase II testing, following a successful meeting with US regulators during which a development path for the drug as a treatment for endometriosis was agreed upon.
As a result of the pre-Investigational New Drug meeting with the US Food and Drug Administration, the Edinburgh-based pharmaceutical group says it now expects to submit plans for the first Phase II study design sometime this year.
Current treatments for endometriosis include GnRH agonists, but these can induce unpleasant side effects similar to those experienced by menopausal women, such as hot flushes, reduced libido and loss of bone density, due to a severe reduction in oestrogen levels.
Phase I trials of Teverelix LA, however, indicate that the agent may side-step such side effects because of its ability to reduce oestrogen levels to a lesser extent, in a dose-dependent manner, and, encouragingly, it appears to have no affect on certain bone absorption markers either.
Unmet need
According to Ardana chief Dr Huw Jones, there is a “high unmet medical need for an effective treatment for endometriosis which does not produce menopausal symptoms or a loss of bone mineral density”, and, as one in 10 women is thought to have the condition, this market is a potentially lucrative one for the firm.
The company is also assessing the drug in prostate cancer and benign prostatic hyperplasia, and investors were obviously pleased with its progress in endometriosis, as shares were up nearly 1.9% at 39.7 pence at close of play yesterday.
