Acacia Pharma kicks off final component of PhIII program as NDA target date nears

Acacia Pharma has begun the fourth and final component of the Phase III trial program for Baremsis. And, with work to test Baremsis as a treatment for postoperative nausea and vomiting (PONV) now underway, Acacia has set its sights on including data from the study in a NDA in the back half of the year.

Acacia Pharma CEO Julian Gilbert

The final trial, which is the second to test Baremsis as a treatment for PONV, will administer one of two doses of the drug or a placebo to 560 people who develop postoperative nausea despite having received an antiemetic prophylactic prior to surgery. Acacia is looking to see whether Baremsis does a better job than placebo in preventing the recurrence of vomiting or need for for further antiemetic rescue in the 24 hours following treatment.

Cambridge, U.K.-based is running the study in parallel to another Phase III trial of Baremsis, in which the drug is being administered to surgical patients who didn't receive a prophylactic and then went on to develop PONV. The two trials are contributing half of the data set being built by Acacia. For the other half, Acacia tested Baremsis as a prophylactic, resulting in data showing the drug significantly improved the complete response rate when added to current standard of care.

The patchwork of trials is representative of Acacia's plans for Baremsis. "We are looking to get a broad label," Acacia CEO Julian Gilbert told FierceBiotech. The plan is to file for approval of Baremsis in both treatment and prophylactic settings in the second half of the year, setting Acacia up to go after the whole PONV market.

"Our internal forecasts suggest the opportunity is ultimately likely to be split fairly evenly between treatment and prophylaxis," Gilbert said. "We envisage that physicians will first get experience using the drug in the treatment setting, and then start to move it back into prophylaxis." Baremsis is likely to be used initially as a treatment because physicians have few options once PONV has taken hold.

Before Acacia can execute this commercial strategy, it will need to top up its bank balance. "We have the money to get through to filing," Gilbert said. Acacia tried to raise cash through an IPO in London late last year, only to back away from the plan after the biotech market went into freefall. While the IPO market remains challenging, Gilbert is confident Acacia can look closer to home for support.

"We have very supportive investors," he said.

- read the statement (PDF)

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