Enlivex, a drug developer based in Israel, has released one-year results from a trial of its experimental knee arthritis shots. The company says the treatment’s benefit lasted a full year in older patients on one of its measures, though not on others.1 Patients got three injections of the treatment, called Allocetra, into the knee. Among those aged 64 and older, 79.2% counted as “responders” after 12 months, compared with 47.6% of those who got a placebo (a dummy shot).1 The results are a company announcement and have not been published in a peer-reviewed journal.
What happened
On November 2, Enlivex announced 12-month results from the second stage of its knee osteoarthritis trial.1 Osteoarthritis is the “wear and tear” kind of arthritis, in which a joint becomes painful and stiff. This stage was randomized and placebo-controlled, meaning patients were assigned by chance to get either the real treatment or a dummy.1 It was also double-blind, so neither patients nor their doctors knew who got which.2 In total, 134 patients were randomized and treated.1
A “responder” here was a patient whose knee pain went down and whose knee function went up.1 The company reported that the gap between the treatment and placebo groups at one year was statistically significant, with a p-value of 0.027.1 A p-value is a measure of how likely a gap this size would be if chance alone were at work. Values below 0.05 are usually treated as meaningful.
Investors reacted coolly. On the day of the news, Stock Titan’s price tracker showed Enlivex shares about 18% below the previous close.1
The evidence so far
The trial tracked knee pain and function on a standard patient questionnaire called WOMAC, scored from 0 to 100.1 The company has reported results at three months, six months and one year.3 Three months was the trial’s main checkpoint.3 For patients aged 64 and older, the reported results were:
- At three months: responder rates were 80% higher than placebo (p=0.019). Pain scores were 17.5 points better than placebo and function scores 19.3 points better, both statistically significant.1
- At six months: pain was 15.4 points better and function 19.5 points better than placebo, both statistically significant. Responder rates were 39% higher, but that difference was not statistically significant (p=0.168).1
- At one year: responders were 79.2% versus 47.6% (p=0.027). Pain was 12.2 points better than placebo (p=0.113) and function 13.1 points better (p=0.067). Neither of those score gaps reached statistical significance.1
Enlivex also said age was the strongest predictor of who responded, with the treatment’s effect growing as patients got older.1 The company added that physical performance tests and early-stage blood marker and imaging analyses backed up what patients reported.1 It has not released those data in detail.
On safety, the company said there were no serious side effects linked to the treatment through one year. Side effects were mostly short-lived, mild to moderate reactions in the knee.1
What it does not show yet
The headline numbers come from a subgroup: patients aged 64 and older. The sources do not say how many of the 134 patients were in that group. The trial was built with this kind of search in mind. Its protocol included a mid-trial review by an independent party, partly to help identify a possible “responder sub-group” to guide later testing.2 Findings from a subgroup picked this way are best treated as ideas to test, which is why the company is running a new trial limited to older patients.
The picture over time is also mixed. Pain and function each improved clearly over placebo at three and six months. By one year, both still leaned toward the treatment but no longer passed the usual test of statistical significance.1 The responder measure went the other way: significant at three months, not at six, and significant again at one year.1
Results for the full group at one year were not given in the sources. At three months, Enlivex had reported a 24% reduction in knee pain and a 26% improvement in function across all treated patients, compared with placebo.2 For patients with age-related arthritis, it reported much larger gains of 72% and 95%.2
Nothing in these results shows whether the shots change the joint itself. No medicine approved in the US or Europe has been shown to stop, slow or reverse structural damage in an arthritic joint.2
Who is behind it
Enlivex, listed on the Nasdaq, runs and pays for the trial. All the results come from the company.2 It describes itself as a “macrophage reprogramming immunotherapy company.” Macrophages are immune cells that help control inflammation. The company calls Allocetra a universal, off-the-shelf cell therapy designed to reset these cells to a balanced, calmer state.2
When the three-month data came out in August 2025, chief executive Oren Hershkovitz said:
We believe these results provide clear indication that Allocetra™ has the potential to become a novel, safe and effective treatment for knee osteoarthritis, a growing market with significant unmet medical need.
That statement was made in a company press release.2 Enlivex has other business lines too. Stock Titan’s summary of its recent news lists holdings of a cryptocurrency token, called RAIN, alongside its drug work.4
How it fits the field
Osteoarthritis is the most common form of arthritis. The company, citing published estimates, says it affects more than 32.5 million Americans and more than 300 million people worldwide.2 It also says 40% of men and 47% of women develop knee osteoarthritis in their lifetimes.3 The condition accounts for more than one million US hospital stays a year, mostly for joint replacement.2
In July 2026, the US Food and Drug Administration (FDA) gave Allocetra a “Regenerative Medicine Advanced Therapy” designation for age-related knee osteoarthritis in people 64 and older.4 This label is meant to speed up development of regenerative treatments that show early signs of helping in serious conditions. According to Enlivex, it allows closer early contact with the FDA and possible eligibility for faster review paths.4 It is not an approval. The FDA also asked for a meeting with the company to discuss its plans for further trials.4
What to watch next
Enlivex is running a larger randomized, controlled trial limited to patients 64 and older, in the US and Europe.4 It expects first results by the end of the second quarter of 2027, which ends in June.1 The sources differ on the size of that trial. In July, the company said it was aiming for 182 patients.4 Stock Titan’s record of an October 28 update says 135 patients have been randomized so far.1
The key questions for that trial are whether the benefit seen in older patients shows up again in a study designed for them from the start, and whether pain and function scores hold up over time. Publication of the full data from this trial would also let outside experts judge the subgroup results for themselves.
