04 January 2012
Phase 2 Study Initiated With APD421 In Post-Operative Nausea & Vomiting (PONV)
Cambridge, UK – 4th January 2012: Acacia Pharma, a pharmaceutical company specialising in the development of drugs for cancer supportive care, announces the initiation of a Phase 2 study 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.
APD421 comprises an intravenous formulation of a currently marketed dopamine D2 antagonist for the new, patent-protected, use of management of PONV. Acacia Pharma has generated positive Phase 2a clinical data when the drug was given prophylactically to cancer patients being treated with the highly emetogenic chemotherapeutic agent, cisplatin. These data indicate that APD421 has the potential to be an effective anti-emetic in man with particular value in controlling nausea, a major unmet need.
The APD421 Phase 2 study is taking place in 13 major centres in France, Germany and the USA and will recruit 200 surgical patients at moderate to high risk of suffering PONV. The trial compares 3 doses 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 being studied as a secondary endpoint. The study is expected to complete second quarter of 2012.
PONV offers Acacia Pharma a rapid, low risk 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 the active ingredient. APD421 has been widely used at much higher doses as a CNS agent for 25 years. The active ingredient in APD421 is also being developed as APD403 for the prevention of chemotherapy induced nausea & vomiting (CINV).
More than 130 million surgical procedures are performed worldwide each year, with PONV occurring in approximately 35% of cases 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 require rescue therapy in the first 6 hours after surgery, representing a substantial commercial opportunity.
Dr Gabriel Fox, Acacia Pharma’s Chief Medical Officer commented: “We are delighted to be working with an outstanding group of investigators, including some of the world’s leading authorities on PONV. A positive result will pave the way not only for APD421 in PONV, but also for the development of its sister product, APD403 in CINV.”
Acacia Pharma’s CEO, Dr Julian Gilbert, added: “We are pleased to have started this Phase 2 dose ranging study in Acacia Pharma’s initial indication of PONV. The data we have generated to date clearly demonstrate anti-emetic activity in man and therefore we have high hopes of a successful outcome in this trial.”