Acacia Pharma Initiates Pivotal Phase 3 Studies with APD421 in Post-Operative Nausea & Vomiting (PONV)
CAMBRIDGE, England, September 17, 2013 /PRNewswire/ –
Acacia Pharma, a pharmaceutical company specialising in the development of drugs for
supportive care, announces the initiation of two pivotal Phase 3 studies of APD421 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.
The Phase 3 studies are taking place in 19 major centres in France, Germany and the
USA. They will recruit a total of 680 surgical patients at moderate to high risk of
suffering PONV (patients with two or more of the four established “Apfel” risk factors for
PONV). The trials compare the optimal dose of APD421 against placebo, the primary endpoint
being no vomiting or retching and no requirement for anti-emetic rescue medication in the
first 24 hours after surgery. The incidence and severity of nausea is also being studied.
The studies are expected to complete in the first quarter of 2014.
APD421 comprises an intravenous formulation of the marketed dopamine D2 /D3 antagonist
amisulpride, for the completely new, patent-protected, use of management of PONV. Acacia
Pharma has generated highly positive Phase 2 clinical data on APD421, showing the optimal
dose significantly reduced the PONV rate from 69% in the placebo group to 40% (p=0.006).
APD421 was equally efficacious against both vomiting and nausea.
More than 130 million surgical procedures are performed worldwide each year, with PONV
occurring in approximately 35% of cases in untreated patients and in 70% of those classed
as high risk. Despite a number of anti-emetics in common use, many patients still suffer
post-operatively with vomiting and especially nausea. About a third of those given
prophylaxis for PONV still require rescue therapy in the first 6 hours after surgery,
representing a substantial unmet medical need and commercial opportunity.
PONV offers Acacia Pharma a rapid development opportunity for APD421, owing to the
acute nature of the condition, the large number of surgical procedures and the
well-documented, benign safety profile of amisulpride, which has been widely used at much
higher doses as an antipsychotic agent for 25 years. Amisulpride is also being developed
by Acacia Pharma as APD403 for the prevention of chemotherapy induced nausea & vomiting
Dr Gabriel Fox, Acacia Pharma’s Chief Medical Officer commented: “Our Phase 3
programme will give a very robust read-out on the efficacy and safety of APD421 compared
to placebo in a broad population of surgical patients at risk of suffering PONV. We have
been highly encouraged by the positive feedback from regulatory agencies and experienced
clinical investigators in Europe and the US and look forward to seeing the data from these
Acacia Pharma’s CEO, Dr Julian Gilbert, added: “We are delighted to have initiated
these Phase 3 studies so soon after securing our recent funding. The Phase 2 data we
generated last year were excellent and we are confident of obtaining similar results in
these bigger pivotal clinical studies.”
About Acacia Pharma
Acacia Pharma (http://www.acaciapharma.com) is a pharmaceutical company focused on
cancer supportive care, 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 range of
supportive care indications such as nausea & vomiting, xerostomia (dry mouth) and cachexia
(muscle wasting) 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. In addition, Acacia Pharma’s products are
expected to reach the market quickly given that they are based on the novel use of
Acacia Pharma is led by an experienced management team who have already successfully
built and exited a number of 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.
SOURCE Acacia Pharma