a new way to test these patients. With sequential parallel comparison design, or SPCD, patients are split randomly into a treatment arm and a placebo arm of the trial. The placebo patients who don’t show a response are then randomized a second time into either a placebo or treatment arm. It’s a way to “wash out” a lot of placebo responders—the “professional patients” who start feeling better simply by joining a trial.
In an interview earlier this year, Fava told Xconomy there have been about 25 psychiatric trials since 2003 using SPCD, a tiny number compared to more than 300 trials a year in indications where the placebo effect is significant, he says.
One of the most advanced SPCD trials is being run by Alkermes (NASDAQ: [[ticker:ALKS]]) to test its drug against major depression. The suite of Phase 3 tests, dubbed FORWARD, are slated to finish in early to mid 2016. Alkermes CEO Richard Pops told Xconomy earlier this year that SPCD is one way to blunt the placebo effect, “which has been a longstanding objective.”
“It’s not like you’re cutting corners, or you’re trying to embellish a signal that’s faint, it’s simply a way of minimizing placebo response,” Pops said.
Fava, who is or has been a consultant to Alkermes and a long list of other drug companies, said that better trial design is only part of the solution. Clinical sites, like hospitals, need to do a better job of patient selection—sometimes called quality assurance—instead of sending vans to homeless shelters to pick up people to participate, for example, or conducting interviews that “lead the witness,” Fava said.
Still, the Alkermes trial will be closely watched as part of the new wave of drugs that rely on deeper understanding of patients and biology.
Not all the new efforts focus on pharmaceuticals. As I wrote in March, mental health researchers and providers are moving toward digital therapies, used with or without drugs, to help patients with conditions that range from post-traumatic stress to autism to depression.
In this new rush of neurological intervention, money plays a big part, too. Denali Therapeutics has a ton of it, as well as at least five Genentech alumni in top positions. The South San Francisco, CA-based startup will deploy its initial $217 million commitment from Arch, Flagship Ventures, the State of Alaska Permanent Fund, and Fidelity to do basic research but also license work from the outside.
BlackThorn isn’t likely to pull down the same commitment as its Arch portfolio partner Denali. But one hallmark of the biotech boom is that early stage investors are not often shy about funding high risk startups with high risk capital. And even though neuroscience is somewhat back in fashion, there’s no argument that launching a new firm like BlackThorn is still high risk.
—Deputy Biotechnology Editor Ben Fidler contributed to this report.
