Adynxx says that their second shot at statistically significant results in a midstage study for their lead pain drug proved the charm. The San Francisco-based biotech didn't post any data, but CEO Rick Orr said that the drug hit the primary endpoint without raising any red flags on the safety side.
Clearing that hurdle leaves Adynxx plotting a course into late-stage development next year, says Orr, who's now in the process of planning a slate of relatively small studies that cut across "surgical models" for AYX1. And in the meantime, the venture-backed company says it will study how best to raise the money that will be needed to cover the big gap between Phase II and registration data.
Adynxx hasn't exactly been flying under the radar, but it slipped largely unnoticed past the first Phase II, which failed the primary endpoint, as well as Cubist's decision to pass on an option to purchase before Merck ($MRK) snapped up the big company in a $9.5 billion deal.
"We saw a clear treatment effect," Orr noted about that first Phase II in late 2013. And while it failed the primary endpoint, he conceded, it provided the basis for the company to set the stage for its second Phase II study with a big increase in dosing.
The highlights: The second Phase II recruited 120 patients and divided them into two groups, the drug cohort and a separate arm of patients who received the standard of care plus a placebo. The drug group posted a clinically significant improvement in pain reported over a 7- to 28-day stretch following knee-replacement surgery.
"In our view we believe that there's really a significant unmet medical need for new treatments and new approaches," says Orr, noting that most current treatments focus on symptom relief while their EGR1-targeting drug looks to prevent pain from occurring in the first place by interfering with a cascade of effects in a key pain pathway. And by offering a nonopioid alternative, they can promise to do it without stirring the hue and cry over easily abused pain therapies.
That kind of story might sit well with public market investors, he adds, noting that the company is considering joining the queue for the still-bubbling biotech IPO market. Adynxx is also planning to push a follow-up pain drug into the clinic to start beefing up its pipeline. Up till now, most of the financing for the company has come from Domain. And Orr says that the virtual 7-member team currently running the company will be beefed up as Adynxx preps for Phase III.