Press Releases

10 May 2019

BARHEMSYS® Significantly Improves PONV in Rescue Treatment of Ambulatory Patients

New post-hoc subset analysis from positive Phase 3 trial selected as part of the Excellence and Innovation Awards to be presented at SAMBA 2019  
Cambridge, UK and Indianapolis, US – 10 May 2019: Acacia Pharma Group plc (“Acacia Pharma”, the “Company”) (EURONEXT: ACPH) announces that an abstract reporting additional data and analyses from its positive Phase 3 clinical trial of BARHEMSYS® (intravenous amisulpride) as a rescue treatment for post-operative nausea & vomiting (PONV) has been selected for oral and poster presentation at the 34th Annual Meeting of the Society for Ambulatory Anesthesia (SAMBA) in Austin, TX, USA (9-11 May). 
The new post-hoc subset analysis (details below) found that significantly more ambulatory (day-case) surgical patients maintained a complete response (CR), defined as no vomiting or retching episodes (excluding any events in the first 30 min) or administration of antiemetic rescue medication in the 24 hours after dosing, with 10 mg BARHEMSYS than with placebo. Furthermore, in ambulatory patients, the median time to treatment failure was 160 minutes with placebo but was not reached with 10 mg BARHEMSYS.
The abstract has been ranked by SAMBA as one of the top 3 abstracts submitted and will be presented as part of the Excellence and Innovation Awards. Primary study data were previously published (online-first in 2018) by Habib et al. in Anesthesiology (Ref. 1).
“We are honoured that SAMBA has selected these data on BARHEMSYS as part of its Excellence and Innovation Awards programme,” commented Dr Gabriel Fox, Acacia Pharma’s Chief Medical Officer. “We see this as a testament to the hard work put in by study investigators and Acacia Pharma colleagues, as well as the continuing importance of PONV in anaesthesiology and post-operative care.”
In the new post-hoc analysis, significantly more ambulatory patients (35 of 68 pts, 51%) had a CR in the 24 hours after dosing with 10 mg BARHEMSYS than placebo (21 of 61 pts, 34%; P=0.024). In the ambulatory subset, the CR rate with 10 mg BARHEMSYS was 65% at 2 hours post-dosing and 51% at 24 hours, whereas in in-patients, it was 72% at 2 hours and 38% at 24 hours.
This subset analysis reports post-hoc outcome measures from Acacia Pharma’s positive 702-patient, randomised, double-blind, placebo-controlled Phase 3 study. This study met its primary endpoint showing that a single 10 mg dose of BARHEMSYS was significantly more effective than placebo at treating PONV after failed prophylaxis.
The proportion of patients with one or more treatment-emergent adverse events was 43% in the group receiving 10 mg BARHEMSYS and 48.1% in the placebo group. The only adverse events occurring in at least 5% of patients in either group were nausea 24 hours or more after treatment (12% with BARHEMSYS 10 mg vs 13% with placebo), flatulence (6% vs 8%), constipation (5% vs 7%), vomiting 24 hours or more after treatment (4% vs 6%), headache (4% vs 7%), infusion site pain (5% vs 4%) and pruritus (4% vs 6%).
Details of the oral and poster presentation are:
Abstract title: Amisulpride is Effective for Rescue Treatment of Ambulatory Patients with Postoperative Nausea and Vomiting: Data from a Randomized, Placebo-Controlled, Phase III Study.  
Authors: Bergese S.D, Uribe, A., Bichajian, L., Ashburn, C., Fox, G.M. and Habib, A.S. 
Date/time: Saturday 11 May, 12:00 noon – 13:30 Central Daylight Time
1. Habib, A.S. et al. Amisulpride for the Rescue Treatment of Postoperative Nausea or Vomiting in Patients Failing Prophylaxis – A Randomized, Placebo-controlled Phase III Trial. Anesthesiology 2019;130(2):203-212.
2. Gan, Tong J., et al. Consensus guidelines for the management of postoperative nausea and vomiting. Anesthesia & Analgesia 2014; 118:85-113.
Acacia Pharma Group plc
Julian Gilbert, CEO
Christine Soden, CFO
+44 1223 919760
Citigate Dewe Rogerson (Financial PR) 
Mark Swallow, Shabnam Bashir, David Dible
+44 20 7638 9571
About PONV
PONV is a common complication of surgery, occurring in approximately 30% of surgical patients and up to 80% of high-risk patients. It is associated with the use of anaesthetic gases and opioid pain-killers and is particularly common following gynaecological, abdominal, breast, eye and ear operations, especially those lasting an hour or more. PONV has been ranked as the most undesirable of all surgical complications in some patient surveys.
Acacia Pharma estimates that approximately 65 million surgical procedures are conducted in the US each year that are eligible for antiemetic use to prevent PONV. Based on market research, Acacia Pharma estimates that the total market in the US for high risk prophylactic and rescue treatment comprises an estimated 34 million patients annually.
About Acacia Pharma
Acacia Pharma is a hospital pharmaceutical company focused on the development and commercialisation of new nausea & vomiting treatments for surgical and cancer patients. The Company has identified important and commercially attractive unmet needs in nausea & vomiting and has discovered two product candidates based on the same active ingredient, amisulpride, to meet those needs.
The Company’s lead project, BARHEMSYS® for post-operative nausea & vomiting (PONV), has generated positive results in four Phase 3 clinical studies. Its sister project, APD403 for chemotherapy induced nausea & vomiting (CINV), has successfully completed one proof-of-concept and one Phase 2 dose-ranging study in patients receiving highly emetogenic chemotherapy.
Acacia Pharma is based in Cambridge, UK and its US operations are centred in Indianapolis, IN. The Company is listed on the Euronext Brussels exchange under the under ISIN code GB00BYWF9Y76 and ticker symbol ACPH. 
Forward looking statement
This announcement includes forward-looking statements, which are based on current expectations and projections about future events. These statements may include, without limitation, any statements preceded by, followed by or including words such as "believe", "expect", "intend", "may", "plan", "will", "should", "could" and other words and terms of similar meaning or the negative thereof. Forward-looking statements may and often do differ materially from actual results. These forward-looking statements are subject to risks, uncertainties and assumptions about the Company and its subsidiaries and investments, including, among other things, the development of its business, trends in its operating industry, and future capital expenditures and acquisitions. By their nature, forward-looking statements involve risk and uncertainty because they relate to future events and circumstances. Any forward-looking statements reflect the Company's current view with respect to future events and are subject to risks relating to future events and other risks, uncertainties and assumptions relating to the Group's business, results of operations, financial position, prospectus, growth or strategies and the industry in which it operates. Save as required by law or applicable regulation, the Company and its affiliates expressly disclaim any obligation or undertaking to update, review or revise any forward-looking statement contained in this announcement whether as a result of new information, future developments or otherwise. Forward-looking statements speak only as of the date they are made.

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