Cambridge, UK and Indianapolis, US – Acacia Pharma (EURONEXT: ACPH) announces results from its latest study of BARHEMSYS™, its anti-emetic currently under FDA review for the management of post-operative nausea & vomiting (PONV).
The study did not find a significant risk for heart rhythm disturbances (arrhythmias) at the highest proposed dose of BARHEMSYS, given alone or in combination with intravenous ondansetron, a widely used PONV therapy with a known effect on the heart trace.
The data confirm that a single 10 mg dose of BARHEMSYS, which has previously been shown to reduce PONV in clinical trials, will not have a clinically significant effect on the QTc interval, part of the ECG trace which is an important indicator of cardiac risk, even when given with ondansetron. If approved, BARHEMSYS is likely to be given to many patients also receiving ondansetron.
In 30 healthy volunteers, the average maximum effect on the QTc interval of a single 10 mg dose of BARHEMSYS, infused over one minute, was 5.2 milliseconds (90% confidence interval 3.53-6.96 milliseconds). When a standard 4 mg dose of IV ondansetron was given at the same time, the average maximum effect was 7.3 milliseconds (90% confidence interval 5.48-9.16 milliseconds). The internationally agreed threshold level of regulatory concern for serious arrhythmias, such as torsade de pointes, is a mean effect on QTc of 10 milliseconds.
The randomised, double-blind, placebo-controlled, cross-over study, conducted in a specialist Phase 1 trials unit in London, UK, also demonstrated that a second 10 mg dose of BARHEMSYS, given two hours after the first, had a similar pharmacokinetic profile and did not significantly affect the QT or clinical safety profile of the drug. No serious adverse events were reported in the trial and there was no material difference in safety profile between BARHEMSYS (with or without concomitant ondansetron) and placebo.
The most common adverse events were infusion site pain/discomfort, which occurred in eight subjects (28%) with BARHEMSYS alone, nine subjects (30%) with BARHEMSYS plus ondansetron and 12 subjects (40%) with placebo; and headache, which occurred in four subjects (14%) with BARHEMSYS alone, three subjects (10%) with BARHEMSYS plus ondansetron and two subjects (7%) with placebo.
BARHEMSYS is currently under review by FDA for the proposed indications of the treatment of established PONV, whether or not prior prophylaxis was given, and the prevention of PONV, alone or in combination with other antiemetics, with a target action date of May 5, 2019.
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. Acacia Pharma 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.
Acacia Pharma’s lead project, BARHEMSYS™ for post-operative nausea & vomiting (PONV), has generated positive results in four Phase 3 clinical studies. A New Drug Application (NDA) for BARHEMSYS is under review by the US Food and Drug Administration (FDA). 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 centered in Indianapolis, IN. The Company is listed on the Euronext Brussels exchange under the under ISIN code GB00BYWF9Y76 and ticker symbol ACPH.
About Gilde Healthcare
Gilde Healthcare is a specialized European healthcare investor managing €1 billion across 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, 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 Benelux and DACH-region. The portfolio consists of healthcare providers, suppliers of medical products and other service providers in the healthcare market.
Gilde Healthcare II is supported by the European Communities Growth and Employment Initiative, MAP – ETF Start-up Facility.