EP Vantage interview – Acacia seeks late-stage validation with new VC cash

Acacia Pharma this week unveiled the biggest venture capital round raised by a UK-based drug developer so far this year, gathering £15m ($23.5m) in a Series B round. The company is focused on cancer supportive care products and the cash will enable it to complete phase III trials on its lead project and make two others ready for pivotal studies.

The company’s advanced pipeline attracted investors, chief executive Julian Gilbert says – he expects to file APD421, a treatment for post-surgical nausea and vomiting, with regulators in the third-quarter of next year. And he hopes that the company’s novel approach will ultimately attract partners; its two emesis products employ a mechanism of action new to this field.

Finding a purpose

Both APD421 and APD403 – in development for chemotherapy-induced nausea and vomiting (CINV) – have the same active ingredient, a repurposed D2/D3 antagonist that has been on the market for many years. The class is better known for its anti-psychotic properties; Acacia has reformulated an as yet undisclosed drug.

Phase IIa data on APD403 revealed promising efficacy in reducing the emesis side effects of chemotherapy; the project’s apparent big impact on nausea in particular is what Mr Gilbert hopes will differentiate it in a competitive and highly genericsed market.

“There are some very good drugs out there for chemotherapy-induced nausea and vomiting, but they are not very good at preventing the nausea,” he says. “So we believe our drug could be added to current regimens to overcome the one element that is still an unmet need and improve response rates.”

It is standard practice to combine emesis drugs to treat the sometimes horrendous side effects of chemotherapy. The 5-HT3 antagonists, the NK-1 antagonists and the much older class of dopamine D2 antagonists are all widely used.

“What we come in with is a D2/D3. It has a novel mechanism: it specifically tackles nausea and it can be added to all other combinations,” he says.

The phase IIa trial was conducted in combination with ondanestron – GlaxoSmithKline’s former 5-HT3 blockbuster Zofran – and found that APD403 added substantial benefits for patients being treated with cisplatin chemotherapy. With the new funds Acacia now intends to conduct a larger phase IIb study.

Pivotal stage

Meanwhile APD421, the same drug but formulated as a very low-dose intravenous injection for use post-surgery, will enter phase III testing in a couple of weeks. The company hopes that its impact on nausea will differentiate it in this setting as well, to combat the side effects of anaesthesia.

Two pivotal trials have been agreed with regulators while a third comparator study against a leading competitor will also be run. Mr Gilbert declined to reveal further details about the studies, but said data should be available in the first quarter of next year.

“This is an incredibly acute indication – was the patient sick 24 hours after surgery? These are extremely speedy studies,” he says.

This clear and short path to market helped persuade investors to participate, Mr Gilbert says – new investors Fidelity Biosciences and Novo A/S led the round while existing investors Gilde Healthcare and Lundbeckfond Ventures participated. They no doubt have their eye on a quick exit – Acacia is a late-stage company by the standards of the venture–backed world.

The plan is to seek partners for the projects, Mr Gilbert says, and he reckons the cash will get the projects to the stage where partners will be interested.

“Post-operative nausea and vomiting is an indication where you need to have phase III data. In CINV, because it’s a much better-known area with clear understanding of what the unmet needs are, it’s more likely to be a phase II requirement,” he says.

A third project, APD515, to treat the extreme dry mouth condition xerostomia that often afflicts advanced cancer patients, will also be prepared for phase III with the new cash. Assuming all the trials succeed, Acacia could soon be boasting a broad portfolio of late-stage cancer care products.

A takeout has to be Acacia’s investors’ ideal outcome; Mr Gilbert has done it before with Arakis, a company with a similar drug-repurposing strategy that he co-founded and that was sold to Sosei in 2005 for £107m. With data due next year, they should soon know whether he will be able to repeat the trick.

To contact the writer of this story email Amy Brown in London at AmyB@epvantage.com or follow @AmyEPVantage on Twitter

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