Date: 2013-10-15
Type of information:
phase: 2
Announcement: results
Company: Acacia Pharma (UK)
Product: APD515, an optimised oromucosal formulation of a currently marketed drug (a muscarinic agonist)
Action mechanism: APD515 is a salivary stimulant.
Disease: xerostemia (dry mouth) in advanced cancer patients
Therapeutic area: Cancer - Oncology
Country: UK, Denmark
Trial details: The randomised, double-blind, placebo-controlled trial will take place in seven centres in the UK and Denmark, enrolling 30 patients with advanced cancer and a persistently dry mouth. Patients received a week of APD515 treatment and a week of placebo, in a randomly assigned order, with a week’s washout in between. Patients graded their symptoms before and after treatment and were asked to record which treatment week they preferred. Patients’ unstimulated salivary flow was measured before and after each treatment period.
Latest
news: * On October 15, 2013, Acacia Pharma, a pharmaceutical company specialising in the development of drugs for supportive care, has announced positive results from its Phase II study of APD515 for the treatment of xerostomia (dry mouth) in advanced cancer patients. The study showed that APD515 significantly reduced the symptoms of dry mouth (the primary endpoint) compared to placebo. The randomised, double-blind, placebo-controlled, cross-over 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. Subjective scoring was done on a standard 100mm visual analogue scale, where 0 represented no dryness at all and 100 the worst dryness possible. The average score for mouth dryness was 26.01 after treatment with APD515 and 43.52 after placebo (p=0.0005).
Other subjective scores, for oral comfort, difficulty speaking and difficulty swallowing, all showed a significant improvement for APD515 over placebo. The overall number of adverse events was low, with no significant difference between APD515 and placebo.The study also assessed whether the blinded treatment had made patients’ symptoms better, worse or unchanged. There was a highly significant difference in favour of APD515, with 17 out of 27 patients judging that their dry mouth had improved after APD515, compared to only seven after placebo. When asked for their treatment preference on a blinded basis at the end of the study, 19 subjects preferred APD515 and only one preferred the placebo.Initially, Acacia Pharma intends to develop APD515 in advanced cancer patients, up to 80% 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.* On July 25, 2011, Acacia Pharma has initiated a Phase II clinical study of APD515, an optimised oromucosal formulation of a currently marketed drug for the new use of treatment of xerostomia (dry mouth) in advanced cancer patients. Xerostomia usually results from reduced salivary flow or altered salivary composition and is common in advanced cancer patients, in the elderly, in people taking a wide range of common medications and in certain conditions such as Sjögren’s syndrome. Results of the trial are expected during the fourth quarter of 2011.
Initially, Acacia Pharma intends to develop APD515 in advanced cancer patients, up to 80% 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 may then be developed in other patient populations once clinical proof of concept has been obtained within the advanced cancer population.
* On February 7, 2011, Acacia Pharma has announced completion of its phase 1 trial with APD515. The trial was conducted in healthy volunteers, each of whom received APD515 at three different doses, by three different methods of administration. APD515 was shown to be safe and well-tolerated across the dose range and by oral, topical (oromucosal) and mixed topical/oral administration. No serious or significant adverse events occurred and no significant changes in blood chemistry, ECGs, vital signs or other clinical tests were seen. The pharmacokinetics and safety results of the study support further development of APD515 and a Phase II study in adult patients with dry mouth is being prepared, with initiation planned for the second quarter of 2011.
