Positive results from a Phase II study of APD515 – a drug to treat xerostomia (dry mouth) in advanced cancer patients – have been reported by Cambridge UK medical technology business Acacia Pharma.
The study showed that APD515 significantly reduced the symptoms of dry mouth compared to placebo.
Dr Julian Gilbert, Acacia Pharma’s CEO said: “Dry mouth is a common and distressing issue in advanced cancer patients that is significantly under-recognised.
“It is associated with a wide range of oral and systemic complications and can contribute to a greatly reduced quality of life. Our market research indicates that a locally delivered, liquid formulation of a suitable salivary stimulant would be of major benefit to many cancer sufferers, and these data indicate that APD515 should meet this profile.”
The trial was conducted in 11 centres in the UK and Denmark and enrolled 32 patients with advanced cancer and a persistently dry mouth.
The study met its primary endpoint of a significant improvement in the subjective scoring of mouth dryness after one week of treatment with APD515 compared to placebo.
Dr. Gabriel Fox, Acacia Pharma’s chief medical officer, added: “This was a robust trial, whose cross-over design allowed us to compare the effects of APD515 and placebo in the same patient.
“The study has shown an unequivocal benefit for APD515 in advanced cancer patients suffering with a dry mouth. APD515 is the first product opportunity to be developed in this hitherto poorly managed patient group.”
Initially, Acacia Pharma intends to develop APD515 in advanced cancer patients, up to 80 per cent of whom suffer from some degree of xerostomia, either as a direct result of their disease or as a consequence of their chemotherapy or other medicines they are taking.
APD515 also has the potential to be developed for other xerostomic patient populations. The company will be optimising the formulation and presentation in preparation for Phase III testing in an advanced cancer population.