Acacia Pharma Announces Positive Phase III Results in Post-Operative Nausea and Vomiting (PONV)
Utrecht, the Netherlands and Cambridge, Massachusetts – Gilde Healthcare, the transatlantic growth capital firm specialized in the healthcare sector, announces that its portfolio company Acacia Pharma (Cambridge, UK) announces positive Phase 3 results with APD421 for the management of post-operative nausea & vomiting (PONV). The data generated demonstrated a statistically significant reduction in the incidence of PONV with APD421 compared to placebo in adult surgical patients at moderate to high risk of suffering PONV (PONV is defined as any episode of emesis or use of antiemetic rescue medication in the first 24 hours after surgery). This condition is a clinically significant problem despite the availability of a range of antiemetic medications. In particular, there remains a clear need for improved options for combination prophylaxis in the highest risk patients, and rescue therapy.
Two double-blind, placebo controlled, Phase 3 studies were conducted in 19 major centres in the US, France and Germany, and recruited a total of 689 surgical patients with two or more of the four validated “Apfel risk factors” for PONV, of whom 626 were evaluable per protocol. APD421 was significantly superior to placebo (p=0.005), giving a relative risk reduction (RRR) of 19.4% in the incidence of PONV. There was no significant difference in the rate of adverse events between APD421 and placebo. Detailed data from these studies will be presented at an upcoming scientific meeting and/or submitted for publication in a peer-reviewed journal.
The company has engaged J.P. Morgan Cazenove to advise the Board on its strategic options.
About Acacia Pharma
Acacia Pharma is developing supportive care product opportunities for post-surgical and cancer patients. Patients and healthcare professionals urgently need new and improved interventions in these rapidly expanding, yet poorly served, areas of supportive care, to improve treatment outcomes and patients’ quality of life. The company’s lead project, APD421 for post-operative nausea & vomiting (PONV), has generated positive results in Phase 3 clinical studies. Its sister project, APD403 for chemotherapy induced nausea & vomiting (CINV) is under investigation in a Phase 2 dose-ranging study. In addition, the company has completed a Phase 2 study with APD515 for xerostomia (dry mouth) in advanced cancer patients and a Phase 2a study with APD209 for cancer cachexia (muscle wasting).
Acacia Pharma is led by an experienced management team, members of which have successfully built and exited life sciences companies. Management, Gilde Healthcare, Lundbeckfond Ventures, Novo A/S and Fidelity Biosciences are the Company’s key shareholders. Acacia Pharma is based in Cambridge, UK. www.acaciapharma.com
About Gilde Healthcare
Gilde Healthcare (Utrecht, The Netherlands and Cambridge, Massachusetts) is a transatlantic growth capital investor focused on private healthcare companies. It has over €450 million ($600 million) under management and is actively looking to lead new investments in therapeutics, diagnostics, medical devices and healthcare services. For a list of Gilde’s portfolio companies please visit the website at www.gildehealthcare.com.
Dr Julian Gilbert
Telephone: +44 1223 875132
Pieter van der Meer
Telephone: +31 30 219 2533