Acacia Pharma, a pharmaceutical company specialising in the development of drugs for supportive care, announces the initiation of two pivotal Phase 3 studies of APD421 in the prevention of post-operative nausea & vomiting (PONV). PONV remains a clinically significant problem in patients undergoing major surgery, despite the availability of a range of anti-emetic medications.
The Phase 3 studies are taking place in 19 major centres in France, Germany and the USA. They will recruit a total of 680 surgical patients at moderate to high risk of suffering PONV (patients with two or more of the four established "Apfel" risk factors for PONV). The trials compare the optimal dose of APD421 against placebo, the primary endpoint being no vomiting or retching and no requirement for anti-emetic rescue medication in the first 24 hours after surgery. The incidence and severity of nausea is also being studied. The studies are expected to complete in the first quarter of 2014.
APD421 comprises an intravenous formulation of the marketed dopamine D2 /D3 antagonist amisulpride, for the completely new, patent-protected, use of management of PONV. Acacia Pharma has generated highly positive Phase 2 clinical data on APD421, showing the optimal dose significantly reduced the PONV rate from 69% in the placebo group to 40% (p=0.006). APD421 was equally efficacious against both vomiting and nausea.
More than 130 million surgical procedures are performed worldwide each year, with PONV occurring in approximately 35% of cases in untreated patients and in 70% of those classed as high risk. Despite a number of anti-emetics in common use, many patients still suffer post-operatively with vomiting and especially nausea. About a third of those given prophylaxis for PONV still require rescue therapy in the first 6 hours after surgery, representing a substantial unmet medical need and commercial opportunity.
PONV offers Acacia Pharma a rapid development opportunity for APD421, owing to the acute nature of the condition, the large number of surgical procedures and the well-documented, benign safety profile of amisulpride, which has been widely used at much higher doses as an antipsychotic agent for 25 years. Amisulpride is also being developed by Acacia Pharma as APD403 for the prevention of chemotherapy induced nausea & vomiting (CINV).
Dr Gabriel Fox, Acacia Pharma's Chief Medical Officer commented: "Our Phase 3 programme will give a very robust read-out on the efficacy and safety of APD421 compared to placebo in a broad population of surgical patients at risk of suffering PONV. We have been highly encouraged by the positive feedback from regulatory agencies and experienced clinical investigators in Europe and the US and look forward to seeing the data from these studies."
Acacia Pharma's CEO, Dr Julian Gilbert, added: "We are delighted to have initiated these Phase 3 studies so soon after securing our recent funding. The Phase 2 data we generated last year were excellent and we are confident of obtaining similar results in these bigger pivotal clinical studies."
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