Acacia Pharma initiates Phase IIa clinical trial with APD421 for nausea & vomiting

Cambridge, UK – Acacia Pharma, a pharmaceutical company specialising in the development of drugs for cancer supportive care, announces it has initiated a dose-escalating, Phase IIa proof-of-concept study of its product candidate APD421.

APD421 is an intravenous formulation of a currently marketed dopamine D2 antagonist for the new use of prevention and treatment of nausea & vomiting. Acacia Pharma has shown APD421 to be highly effective in preclinical models of both chemotherapy-induced nausea & vomiting (CINV) and post- perative nausea and vomiting (PONV). APD421 could offer advantages over existing D2 antagonists used as anti-emetics, given its superior therapeutic window. 

The single ascending dose study is taking place in four hospitals in Denmark and the UK, and will enrol up to 54 cancer patients receiving the highly emetogenic chemotherapy drug cisplatin. The primary endpoint will be protection from vomiting and no requirement for anti-emetic rescue medication during the first 24 hours after dosing with cisplatin. 

Upon successful completion of this proof-of-concept study, Acacia Pharma will proceed to a dose-ranging study of APD421 in adult surgical patients. PONV offers the most rapid development opportunity for APD421, owing to the acute nature of the condition and the large number of surgical procedures performed. 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 six hours after surgery, representing a substantial commercial opportunity. More than 130 million surgical procedures are performed worldwide each year, PONV occurring in approximately 35% of cases and in 70% of those classed as high risk. 

Dr Julian Gilbert, Acacia Pharma’s CEO said,

“Acacia Pharma has generated excellent preclinical data on APD421. This innovative proof-of-concept study is designed to confirm that the anti-emetic effects previously seen by Acacia Pharma translate to man, before we embark upon Phase II dose ranging.”

Contacts

Acacia Pharma
Dr Julian Gilbert
Telephone: +44 (0)1223 875130

Citigate Dewe Rogerson
David Dible
Dr Mark Swallow
Telephone: +44 (0) 20 7638 9571

About Acacia Pharma

Acacia Pharma (www.acaciapharma.com) is a pharmaceutical company focused on cancer supportive care, a rapidly developing commercial opportunity. The growth in the cancer supportive care market has been driven by the increasing incidence of cancer, the expansion of effective cancer therapies and the desire to improve both the effectiveness of treatment and the quality of life of cancer patients. 

Acacia Pharma has generated a pipeline of product opportunities addressing a range of supportive care indications such as nausea & vomiting, xerostomia and cachexia using a commercially driven approach to product discovery based on known drugs. This strategy leads to product opportunities with a higher probability of success and enables rapid clinical proof-of concept. In addition, Acacia Pharma’s products are expected to reach the market quickly given that they are based on the novel use of well-characterised pharmaceuticals. 

Acacia Pharma is led by an experienced management team who have already successfully built and exited a number of life sciences companies. Management and Gilde Healthcare are the Company’s key shareholders. Acacia Pharma is based in Cambridge, UK.