New biological insights and increased recognition from FDA are transforming osteoarthritis from a testing ground for new pain therapies into its own high-priority indication.
At least two mechanisms with disease-modifying potential for osteoarthritis (OA) have moved into Phase II and III testing, and dozens of new targets are being explored in preclinical experiments and early-stage clinical trials.
OA, which involves breakdown of the cartilage that cushions joints, is the most common form of arthritis, affecting up to 15% of people over 60 in the U.S. and Europe. However, drug development activity has been scarce in part because the condition has been widely viewed as a normal part of aging.
“There’s been a confluence of recognition that this disease has escaped decent interventions because when you present with OA at a physician, they often just tell you you’re getting old,” said Jamie Dananberg, CMO of Unity Biotechnology Inc.
No therapies are approved for OA, and the standard of care is general analgesics such as non-steroidal anti-inflammatory drugs (NSAIDs), injectable lubricants, and ultimately joint replacement. But NSAIDs come with a host of side effects and only mask the pain, and lubricants are rapidly cleared and have a very short-lived cushioning effect.
“This disease has escaped decent interventions because when you present with OA at a physician, they often just tell you you’re getting old.”
A 2018 draft guidance from FDA on new endpoints for OA trials that go beyond pain metrics has started to change industry’s