Acacia Pharma initiates Phase II study with APD405 in post-operative nausea & vomiting (PONV) - Gilde Healthcare

Acacia Pharma initiates Phase II study with APD405 in post-operative nausea & vomiting (PONV)

June 8, 2009

Cambridge, UK – Acacia Pharma, a pharmaceutical company specialising in the development of supportive care drugs, announces the initiation of a Phase II study of its lead compound, APD405, 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.

APD405 is a novel, intravenous formulation of a drug, which has been marketed for more than twenty years as an oral treatment for central nervous system conditions. Acacia has shown that the drug is also a potent anti-emetic and therefore offers a new and exciting, multi-modal approach to the control of nausea and vomiting.

APD405 is active at both dopamine (D2) and serotonin receptors, two validated mediators of nausea and vomiting. Based on this pharmacological profile and Acacia’s own pre-clinical data, the company is optimistic that the agent will be especially valuable against nausea and against opioid-induced emesis, two areas of the highest unmet need. Future development will also investigate the application of APD405 for the prevention of chemotherapy induced nausea & vomiting (CINV), another important area of unmet need that can significantly impact quality of life for cancer patients.

A Phase I trial conducted in 29 healthy male and female volunteers reported positive data in January 2009, demonstrating that APD405 is safe and well-tolerated across a range of doses. Furthermore, APD405 is not associated with cardiovascular toxicity or extrapyramidal symptoms (such as involuntary movements), which can be serious side effects of other D2-antagonists.

Acacia’s Phase II study is taking place in 18 major centres in France, Germany, Switzerland and the USA and aims to recruit 260 surgical patients, at moderate to high risk of PONV, over the coming six months. The trial compares four different doses of APD405 against placebo, with the primary endpoint being the incidence of nausea or vomiting over the first 24 hours after surgery. The study is expected to complete in the fourth quarter of 2009.

Acacia Pharma’s CEO, Dr Julian Gilbert, commented: “The excellent progress of our lead compound continues with this Phase II proof-of-concept study, which is starting just over a year after we first invested in this programme. We believe this rapid advancement is further validation of our model of developing new uses for existing medicines.

“We are delighted to be working with a truly outstanding group of investigators, including many of the world’s leading authorities on PONV. A positive result in this trial will pave the way not only for APD405 in PONV, but also for its development in CINV, another important area of unmet need in cancer patients.”

About Acacia Pharma

Acacia Pharma is a pharmaceutical company focused on supportive care, particularly cancer supportive care which is 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 number of supportive care indications 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. The Company’s lead product opportunity APD405 for the prophylaxis and treatment of nausea & vomiting has completed Phase I clinical development and is in Phase II clinical evaluation in PONV. Acacia’s second development opportunity, APD209 for cancer cachexia, has completed preclinical evaluation and a Phase IIa Study in cancer cachexia patients has been initiated. In addition, the Company is also working on products for additional supportive care indications such as xerostomia, cancer fatigue and skin toxicities associated with certain new anti-cancer agents. Acacia’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.

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