Acacia announces positive results from final pivotal Phase 3 trial of BAREMSIS™
NDA to be submitted to the US FDA 1H 2017
Cambridge, UK – Acacia Pharma Group Ltd ("Acacia"), the supportive care company, announces positive results from its fourth and final pivotal Phase 3 study investigating its lead product BAREMSIS™ for the rescue treatment of patients who develop post-operative nausea & vomiting (PONV), despite having received prior anti-emetic prophylaxis. No other anti-emetic has a specific label for treating this significant unmet need.
BAREMSIS will be positioned as the drug of choice for treating the 30-40% of surgical patients who suffer PONV despite prior prophylaxis, as well as for combination prophylaxis in high-risk patients. Acacia aims to submit to the US FDA as part of its New Drug Application (NDA) in 1H 2017.
Gilde Healthcare acted as anchor investor in the formation of Acacia and in subsequent financing rounds.
The Phase 3 rescue treatment trial compared two doses of BAREMSIS, a novel dopamine D2/D3 antagonist antiemetic, against placebo in patients with established nausea and/or vomiting after surgery, who had previously received prophylactic anti-emetics. The double-blind study, the first ever major study to investigate rescue with a different class of antiemetic, took place in leading institutions in the USA, Canada, France and Germany and recruited 2,285 patients, of whom 705 (31%) went on to experience PONV and were randomised into the trial. The primary endpoint was the successful resolution of the episode of PONV (no recurrence of vomiting or requirement for further antiemetic rescue) in the 24-hour period after rescue treatment, termed a complete response. The optimum dose of BAREMSIS significantly improved the complete response rate when compared to placebo (p=0.003); the magnitude of effect was consistent with the Company's previous Phase 3 trial results. Detailed data will be presented in relevant scientific meetings and submitted for publication in a peer-reviewed journal.
PONV is distressing, can have a detrimental impact on surgical outcomes and significantly impede the post-operative recovery process. It can delay hospital discharge, lead to unanticipated readmissions increasing healthcare costs and give the patient a poor surgical experience. Better management of PONV can therefore decrease hospital costs and improve patient outcomes and satisfaction scores.
About Acacia Pharma
Acacia Pharma (Cambridge, UK) is a specialty pharmaceutical company focused on the development and commercialisation of new treatments for supportive care of patients with debilitating conditions arising as a consequence of surgery, cancer or cancer treatment. Management, Gilde Healthcare, Lundbeckfonden Ventures, Novo A/S and F-Prime Capital are the Company's key shareholders. Acacia Pharma is headquartered in Cambridge, UK and has US operations in Indianapolis, IN. www.acaciapharma.com
About Gilde Healthcare
Gilde Healthcare is a specialized European healthcare investor managing two business lines: a venture & growth capital fund and a lower mid-market buy-out fund. Gilde Healthcare's venture & growth capital fund invests in medtech, diagnostics, digital health and therapeutics. The portfolio companies are based in Europe and North America. Gilde Healthcare's lower mid-market buy-out fund invests in profitable European healthcare services companies with a focus on the Netherlands, Belgium and Germany. The portfolio consists of healthcare providers, suppliers of medical products and other service providers in the healthcare market.
Since 2001 Gilde Healthcare has raised €800 million ($900 million) for its specialized funds. www.gildehealthcare.com
Gilde Healthcare II is supported by the European Communities Growth and Employment Initiative, MAP – ETF Start-up Facility.