Bone Therapeutics is mulling options for its lead program after the osteoarthritis treatment flopped in a phase 3 study.
The company sought to show that the treatment, a mix of hyaluronic acid, plasma proteins and a fast-acting analgesic, could beat placebo at reducing knee pain from osteoarthritis in a trial of more than 700 patients. Hitting the study’s secondary goal—beating a comparator treatment called Hylan G-F 20—would have been the cherry on top.
After three months, the treatment, JTA-004, did neither.
The company’s stock dipped 33% Monday morning from its closing price of €2.66 on Friday.
Bone Therapeutics CEO Miguel Forte played up the treatment’s safety profile in a statement, even as he called the results “disappointing.”
“Knee osteoarthritis studies are recognized across the industry to be challenging to evaluate. They are also frequently complicated by a high placebo effect,” Forte said in the statement. “We will continue to analyze the data and will consider potential next steps.”
The company highlighted its second most advanced program in the statement, saying it expected to finish recruiting for a phase 2b study in patients with tibial fractures in the first half of next year. It is developing the treatment—an allogeneic, or off-the shelf, cell therapy called ALLOB—for difficult fractures and lumbar spinal fusion.
The phase 2b trial will gauge whether one injection of ALLOB can speed up bone healing and ward off complications. The company expects to report top-line data by the end of 2022, though this timeline is up in the air, thanks to pandemic conditions.
ALLOB was also in a phase 2a study in patients undergoing spinal fusion surgery, which uses rods, screws and bone grafts to stabilize the spine. Two years after treatment, 27 out of 30 patients (90%) had successful bone fusion, the company reported in October 2020.