Acacia Pharma begins APD421 Phase 3 study in combination with standard anti-emetics for PONV

Acacia Pharma Ltd ("Acacia Pharma" or "the Company"), the supportive care company developing products for US and international markets, announces the initiation of a Phase 3 study investigating APD421 in combination with standard anti-emetics, in the prevention of post-operative nausea & vomiting (PONV) in high-risk patients. PONV remains a clinically significant problem in patients undergoing surgery, despite the availability of a range of anti-emetic medications. International consensus guidelines recommend the use of multiple anti-emetics to prevent PONV in high-risk patients.

The study is taking place in approximately 30 leading institutions in the USA, France, and Germany and aims to recruit up to 1,200 surgical patients at high-risk of suffering PONV over the next 6-12 months. The trial compares APD421 plus a standard anti-emetic (for example ondansetron or dexamethasone), against placebo plus the same standard anti-emetic. The primary endpoint is 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 are also being studied. Further studies are planned to investigate the use of APD421 in the treatment of established PONV, with the aim of seeking FDA regulatory approval and bringing the product onto the US market.

Data generated by Acacia Pharma in Phase 2 and Phase 3 clinical trials indicate that APD421, its proprietary low dose intravenous formulation of the marketed dopamine antagonist amisulpride, is an effective, safe anti-emetic. The Company believes that a drug with these characteristics can be used to manage PONV:

• prophylactically in combination with standard anti-emetics (eg 5HT₃ antagonists and/or corticosteroids) in high-risk patients, and
• to rescue patients with PONV despite prior prophylaxis with non-dopamine-antagonist anti-emetics.

Dr Gabriel Fox, Acacia Pharma's Chief Medical Officer commented: "We have already demonstrated the benefit of APD421 when used on its own to prevent PONV. The aim of this study is to show that APD421 is safe and effective when used in combination with other anti-emetics having different mechanisms of action, in patients at high risk of getting PONV. The study is one of the largest PONV studies ever undertaken and is being conducted by many of the world's leading PONV experts in Europe and the US."

Amisulpride is also being developed by Acacia Pharma as APD403 for the prevention of chemotherapy induced nausea & vomiting (CINV).