The UK’s Acacia Pharma is looking at strategic options as its late-stage treatment for post-operative nausea and vomiting moves closer to regulatory filings.
The Cambridge-headquartered group has unveiled positive Phase III results which showed that APD421 demonstrated a statistically significant reduction compared to placebo in the incidence of PONV, a common complication of surgery. Specifically, the two studies, which evaluated 626 patients at 19 centres in the USA, France and Germany, showed a relative risk reduction of 19.4% in the incidence of PONV for the Acacia drug.
Chief executive Julian Gilbert said: that a significant number of patients suffer from PONV “despite routine use of prophylactic antiemetics, predominantly 5HT3s and corticosteroids, increasing healthcare costs and reducing patient satisfaction”. He claimed that “there is a clear need for an efficacious, safe antiemetic with a different mechanism of action for use in combination prophylaxis in the highest risk patients, and to rescue patients who suffer PONV despite receiving prophylaxis".
Dr Gilbert went on to say the data indicate APD421 is an effective dopamine antagonist antiemetic, “which has the potential to become a mainstay of therapy,”. Acacia chief medical officer Gabriel Fox added that dopamine antagonists “were a popular and very efficacious option for anaesthetists seeking to prevent PONV, until the emergence of safety concerns such as heart rhythm disturbances and movement disorders”.
Dr Fox concluded by saying that having completed three studies “with many of the world’s leading experts in PONV”, APD421 shows great promise “without the safety issues previously seen with this class of drugs”. Following the successful trials, the company has now engaged JP Morgan Cazenove to advise the board on its strategic options.