Despite the many avenues for treating pain these days, the Institute of Medicine estimates that it costs the U.S. a whopping $635 billion annually in medical charges and lost productivity. That’s the problem a young San Francisco pharmaceutical startup called Adynxx is trying to address.
Existing drug treatments come with unpleasant or outright dangerous side effects (remember the COX-2 inhibitor brouhaha?), and some opioids can even be addictive. Adynxx is hoping to get around those issues by treating pain at its roots, before it even starts.
The company has two goals, according to founder and chief scientific officer Julien Mamet, who’s also the inventor of the technology: First is to prevent pain after surgery, and second is to treat pain in chronic conditions.
In its first application, the technology is addressing that first point, targeting resting and movement-invoked pain in patients undergoing surgeries on areas of the body below the neck. AYX1 is a single-dose drug that’s injected into the spine before surgery — although Mamet said it could potentially be injected up to 24 hours after surgery and still be effective. It uses small, synthetic pieces of DNA to inhibit the activity of transcription factors that trigger multiple pain-related proteins.
A phase 1 study just completed found the drug to be well tolerated in 30 healthy patients. A phase 2 trial will measure efficacy of the drug in reducing pain that occurs acutely after surgery, during physical therapy and in the long-term in patients having total knee replacements, CEO Rick Orr told MedCity News. Enrollment for that study will begin by the end of the year.
Orr said Adynxx has been funded through phase 2 by a 2010 series A to the tune of $18 million from Domain Associates, with which he has a long-standing relationship. Orr, with backing from Domain, was part of executive teams that grew and exited three pharmaceutical companies over a five-year period. Two of them were antibiotic developers: Peninsula Pharmaceuticals, which was acquired for $245 million in 2005 by a Johnson & Johnson subsidiary, and Cerexa, acquired by Forest Laboratories in 2006 for $480 million. The other was heart drug developer Corthera, snatched up for $620 million by Novartis in 2010.
Orr joined Adynxx in 2010, three years after the company was founded by Mamet. The now seven-employee operation also has other candidates in its pipeline including preclinical drugs for chronic lower back pain and neuropathic pain.
But for now it’s focused on finding out whetherAYX1 actually works for some of the patients receiving the 32 million surgeries done in the U.S. every year. The company faces additional competition from Exparel, a nonopioid local analgesic for postoperative approved by the U.S. Food and Drug Administration last year, and new pain treatment devices being developed in the field of neurostimulation.
Although Orr and Mamet were optimistic about their drug, they were realistic in admitting that won’t be the panacea for pain. “We would expect that it would be administered in addition to current standard of care,” Orr said. “Our further expectation is that it would allow patients to rely less upon current standards of care, meaning fewer opioids would be needed.”
[Photo from flickr user Pink Sherbet Photography]