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Despite Pain Drug’s Mid-Stage Miss, Adynxx Plans a Larger Phase 3 Test

Xconomy San Francisco — 

An Adynxx pain drug has failed to meet the main goal of a mid-stage study, but the company instead points to results in a subset of patients that it says are strong enough to justify advancing the treatment into a larger Phase 3 clinical trial.

Adynxx develops drugs to block proteins that control genes that have been studied for their role in pain. The San Francisco company’s lead drug, brivoligide, targets a protein called EGR1. Adynxx tested the drug as a treatment for post-surgical pain in patients who have undergone knee-replacement procedures.

The Phase 2 study enrolled 210 patients, randomized to receive either the Adynxx drug or a placebo just before undergoing knee surgery. In addition, patients also received standard pain management treatment throughout the study, including prescriptions of opioid drugs. Patients were assessed on a pain measurement scale in the seven to 28 days following surgery. Those given the injectable Adynxx drug did not meet the main goal of pain reduction in a 15-meter walking test. But Adynxx says patients who initially had higher pain scores on this scale and were treated with the Adynxx drug showed a “meaningful reduction in pain and opioid use.”

According to Adynxx, this subset of patients showed a faster recovery from pain and used 37 percent fewer opioids compared to patients in the placebo group—a reduction that the company says is roughly equivalent to 90 5 mg Vicodin tablets. The side effects reported in the study were typical of those in patients who undergo knee replacement.

Adynxx and its investors are trying to position brivoligide as way to reduce the use of addictive opioid drugs. The company says it is now planning a Phase 3 study testing its drug in patients who have high scores on the pain scale. In a prepared statement, Dennis Podlesak, chairman and partner of Adynxx investor Domain Associates, said that the drug could help patients whose high pain levels could require management with more opioid drugs. Domain was an early backer of Adynxx and it was one of the investors that participated in a $16 million Series B round of financing last year to fund the latest mid-stage study.

Adynxx’s approach to treating pain had drawn interest from Cubist Pharmaceuticals, leading to a 2013 deal that gave it the option to license the San Francisco biotech’s pain drug. But after looking at the clinical trial results a year later, Cubist declined to exercise that option. Cubist was later acquired by Merck (NYSE: MRK).

—Knee replacement photo by Flickr user Kim via a Creative Commons license.