Acacia Pharma has hit the primary endpoint in another Phase III trial of its postoperative nausea and vomiting (PONV) drug. The study adds to the burgeoning pool of late-phase data on the drug, which last made headlines in 2014 when it outperformed the placebo in another Phase III trial.Acacia Pharma CEO Julian Gilbert
In the 15 months between the two data readouts, Acacia filed for a £150 million ($220 million) IPO on the London Stock Exchange, only to nix its plan in the face of a tough market for biotech stocks. Had the IPO gone ahead, the data posted this week could have provided an early fillip for investors. Acacia tested its drug, now known as Baremsis but formerly called APD421, in 1,204 surgical patients with three or four of the PONV risk factors. Baremsis was associated with a risk reduction of 22%, a significant result that is comparable to the outcome of the earlier Phase III trial.
The latest study gave patients a standard antiemetic, such as ondansetron or dexamethasone, plus either Baremsis or a placebo. Patients in the Baremsis arm experienced a complete response rate of 57.7%, compared to 46.6% among participants who received the placebo. Acacia thinks the data are strong enough to file for approval as a way to prevent PONV. "We anticipate submitting our NDA to the FDA in the second half of 2016," Acacia CEO Julian Gilbert said in the statement. Acacia is also developing Baremsis as a treatment for PONV. The first of two therapeutic trials is now underway.
Cambridge, U.K.-based Acacia sees Baremsis providing physicians with a third way to prevent PONV, which is currently tackled with 5HT3 antagonists and corticosteroids. A study published in the New England Journal of Medicine in 2004 found that even the most effective combination of drugs failed to prevent PONV in 17% of patients. And with hospitals wary of using the dopamine antagonist component of the regimen, droperidol, because of a black-box warning, Acacia thinks there is a niche for a product that can offer similar effects without the side effects. Baremsis could be that product.
Acacia now finds itself with the data to support a submission to FDA but without the IPO funding it was planning to use to build out its U.S. commercial infrastructure. When Acacia postponed its IPO in October, it said it would rely on existing investors "to execute the key elements" of its strategy. In the year preceding the IPO filing, Acacia considered selling up, outlicensing programs or raising more cash privately before deciding it was best served by going public.
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