Biosplice submits NDA for lorecivivint, a potential first-of-its-kind therapy that aims to slow knee osteoarthritis itself.
Osteoarthritis shapes how millions of people wake up, walk, work and age. California-based biotech Biosplice Therapeutics aims to change that through a New Drug Application (NDA) with the US Food and Drug Administration for lorecivivint (LOR), a drug designed to treat knee osteoarthritis in a fundamentally different way [1].
For decades, osteoarthritis care has been defined by compromise. Patients manage pain while joints continue to deteriorate, often ending in surgery. Biosplice’s submission signals a new and serious attempt to intervene earlier and alter the disease itself.
Lorecivivint is injected directly into the knee joint once or twice a year. That detail alone sets it apart from daily pills or short-term steroid shots. But the bigger distinction lies in what the drug is trying to do.
In clinical trials, LOR did what many osteoarthritis treatments aim for: it reduced pain and improved physical function. But it also did something rarer. Imaging from Biosplice’s Phase 3 OA-07 trial showed that patients treated with LOR maintained, and in some cases improved, the space inside the knee joint where cartilage normally absorbs impact.
That space typically shrinks as osteoarthritis progresses. Preserving it suggests the joint is not breaking down as quickly. For patients, this could mean staying mobile longer, delaying joint replacement and maintaining independence.
In the two-year OA-07 study, patients receiving lorecivivint reported less pain within six months. By one year, they showed improvements not only in pain but also in their ability to move and function, compared with placebo.
What caught researchers’ attention, however, was what happened over time. Patients who initially received a placebo and later switched to LOR also began to show improvements in joint structure. That kind of reversal is rarely seen in osteoarthritis research.
The results build on earlier Phase 2 studies that showed similar benefits, strengthening the case that this was not a statistical fluke, but a repeatable effect.
Osteoarthritis affects older adults disproportionately, which makes safety non-negotiable. Across more than 1,800 patients treated over a decade-long development program, LOR’s safety profile was similar to placebo.
One reason is its localized delivery. The drug remains in the knee joint, with no detectable exposure elsewhere in the body. That matters in a population often managing heart disease, diabetes or other chronic conditions alongside joint pain.
Professor Tim McAlindon of UMass Chan School of Medicine, who advised on the program, described the profile as unusually strong, especially given the drug’s potential to affect disease progression.
Lorecivivint was first identified in 2011. Its NDA submission represents more than ten years of clinical trials, regulatory patience and financial risk, an increasingly rare timeline in biotech.
“After over a decade of clinical trials, we are pleased to be the first company to submit a data package in the US for a potentially disease-modifying drug in knee OA,” said Erich Horsley, CEO of Biosplice [1]. He pointed to a patient journey that is “painful and disheartening,” shaped by limited options and inevitable decline.
Chief Medical Officer Dr Yusuf Yazici highlighted the scale of the opportunity, noting that once approved, LOR could offer both near-term pain relief and long-term structural benefit to roughly 25 million Americans with knee osteoarthritis.
Osteoarthritis is often dismissed as an inconvenience of aging. In reality, it is closely tied to disability, cardiovascular risk and higher mortality – largely because reduced mobility sets off a chain reaction throughout the body.
For us in the longevity sector, preserving joint health is about keeping people active, socially engaged and metabolically healthy for longer. A therapy that slows joint degeneration could extend healthspan.
Whether lorecivivint ultimately earns FDA approval remains uncertain. But its submission alone signals that age-related diseases should be approached not as inevitable declines to be managed, but as biological processes that can be slowed, and perhaps reshaped.
