The U.K. biotech Acacia Pharma has won the embrace of some top-shelf venture players willing to step in to fund a late-stage study of its lead drug. Fidelity Biosciences and Novo A/S joined existing investors Gilde Healthcare and Lundbeckfond Ventures to put up a $23.5 million B round designed to get a new therapy to prevent nausea and vomiting in cancer patients through late-stage development and prospectively into the hands of a commercial partner.
Cambridge, U.K.-based Acacia has been working to develop a significant new use for a currently marketed dopamine D2/D3 antagonist, though Acacia's CEO isn't revealing just yet which commercial product he's working with. The drug has been reformulated so that it can be given in a lower dose intravenously as needed, optimizing its delivery for a new indication. The company's timeline calls for new drug applications in Europe and the U.S. in the third quarter of 2014.
A Phase II study for the lead therapy--APD421, to prevent nausea and vomiting in post-operative (PONV) cancer patients--concluded that the optimal dose just about cut the rate of PONV in half compared to a placebo. And in a small Phase IIa study that read out last fall, the biotech said that a follow-up program for APD403--a combination of its therapy with intravenous ondansetron--prevented vomiting and the need for anti-emetics in 19 of 23 patients (an 83% response rate compared to the company's historical benchmark of 50% for ondansetron alone) after being treated with cisplatin. Only two of the 23 patients reported significant nausea requiring medication.
Acacia's business model is a familiar one in the biotech industry. By "reprofiling" an already approved therapy, the company can significantly dial down the risk involved and follow a carefully focused development program on a lean budget. Acacia is a virtual company, with a trio of fulltime employees and a core group of four consultants, says CEO Julian Gilbert, a veteran of Arakis, a 2005 Fierce 15 company acquired by Sosei in 2005 for £107 million ($166.62 million).
And with this latest raise, the developer plans to get its lead product all the way through Phase III--with mid-stage results for a related indication--on just $37 million in total funds raised.
"We're more virtual than we set out to be," Gilbert tells FierceBiotech. But the seed cash came in 2008, along with the arrival of a global economic hurricane. And that's forced the biotech to be extraordinarily efficient with its cash. The plan now is to line up a partner with solid Phase III data in hand. But when asked, the CEO also conceded that a buyout could make good sense at that point as well. Acacia has no commercial organization, and Gilbert isn't planning on setting one up.
- here's the press release