Enlivex Announces Randomization of 135 Patients in Phase 2b Trial of Allocetra in Age-Related Primary Moderate-to-Severe Knee Osteoarthritis

The ongoing study will compare pain and function changes with placebo at three and six months after treatment.

Rhea-AI Summary

Enlivex (Nasdaq: ENLV) has randomized 135 patients and administered their first Allocetra injection in its Phase 2b knee osteoarthritis trial.

The study plans to enroll 182 patients aged 64 and older with moderate-to-severe age-related symptomatic primary knee osteoarthritis. Recruitment continues in the United States, Denmark and Poland. Enlivex expects topline six-month data by mid-2027.

The randomized, double-blind, placebo-controlled trial evaluates safety and efficacy of injections into the knee joint. Key efficacy measures compare changes in pain and function with placebo at three and six months; additional measures assess quality of life and functional mobility. The study follows Phase 1/2a results described as positive by Enlivex, which supported FDA Regenerative Medicine Advanced Therapy (RMAT) designation granted in July 2026.

Positive

• Minor point135 of a planned 182 patients have been randomized and received their first Allocetra injection.
• Minor point. Forward-looking: it has not happened yet and may not happen.Enlivex expects topline six-month Phase 2b data by mid-2027.
• Minor pointFDA RMAT designation was granted in July 2026, supported by Phase 1/2a data Enlivex described as positive.

Negative

• None.

Key Figures

Patients randomized: 135 of 182 patients Topline data timing: Mid-2027 Minimum patient age: 64 years and older

Patients randomized

135 of 182 patients

Phase 2b trial; first injection administered

Topline data timing

Mid-2027

Expected six-month data

Minimum patient age

64 years and older

Phase 2b trial population

Previous Clinical trial Reports

3 past events · Latest: Oct 19

Same Type 3 events

1. Oct 19

   Trial resource focus

   24h Move

   +1.2%

   Cost reductions redirected resources to the same Phase 2b trial and retained mid-2027 data timing.

2. Nov 24

   Phase IIa clinical data

   24h Move

   +13.7%

   Phase IIa reported significant pain and function improvements versus placebo at three and six months.

3. Aug 18

   Phase I/II clinical data

   24h Move

   -31.3%

   Phase I/II reported improvements versus placebo, including reductions in pain and gains in function.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

regenerative medicine advanced therapy (rmat), intra-articular, double-blind, placebo-controlled

4 terms

regenerative medicine advanced therapy (rmat) regulatory

"FDA Regenerative Medicine Advanced Therapy (RMAT) designation granted in July 2026"

A Regenerative Medicine Advanced Therapy (RMAT) is a U.S. regulatory designation for cell, gene and tissue-based treatments addressing serious or life-threatening conditions that shows early evidence of potential benefit. Think of it as a VIP lane with extra access to the regulator — more interaction, guidance and faster review — which can shorten development time and lower costs, making a program more valuable to investors, though it does not guarantee approval.

intra-articular medical

"efficacy and safety of intra-articular injections of Allocetra"

An intra-articular treatment is one that is injected directly into a joint space, such as the knee or shoulder, to deliver medication or therapy right where the problem is. For investors, this matters because intra-articular delivery can improve effectiveness and reduce systemic side effects compared with pills or injections elsewhere in the body, affecting a drug’s clinical value, regulatory pathway, market appeal, and reimbursement prospects.

double-blind medical

"randomized, double-blind, placebo-controlled Phase 2b trial"

A double-blind process means that neither the people conducting an activity nor the people involved know certain key details, such as who is receiving a treatment or a placebo. This approach helps prevent bias from influencing the results, making the outcome more trustworthy. For investors, it ensures that decisions or judgments are based on unbiased information rather than preconceived opinions or expectations.

placebo-controlled medical

"randomized, double-blind, placebo-controlled Phase 2b trial"

"Placebo-controlled" describes a testing method where one group receives the actual treatment or intervention, while another group receives a harmless, inactive version called a placebo. This approach helps determine whether the real treatment has genuine effects beyond psychological expectations. For investors, understanding this ensures confidence that reported benefits are real and not influenced by bias or false perceptions.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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•      135 patients, out of a total planned 182, have been randomized and were administered the first injection of Allocetra^TM; enrollment actively ongoing at clinical sites in the United States and in Europe

•      Topline six-month data expected by mid-2027

•      Phase 2b builds on positive three- and six-month Phase 1/2a data, which supported FDA Regenerative Medicine Advanced Therapy (RMAT) designation granted in July 2026

Nes-Ziona, Israel, Oct. 28, 2026 (GLOBE NEWSWIRE) -- Enlivex Ltd. (Nasdaq: ENLV) ("Enlivex" or the "Company"), a quality longevity company powered by a prediction markets treasury, today announced that 135 patients, out of a total planned 182, have been randomized and were administered the first injection of Allocetra^TM in the Company’s Phase 2b clinical trial of Allocetra™ for the treatment of patients with moderate-to-severe age-related symptomatic primary knee osteoarthritis (OA). The trial is actively recruiting at clinical sites in the United States, Denmark and Poland, and the Company expects to report topline six-month data by mid-2027.

The global, multicenter, randomized, double-blind, placebo-controlled Phase 2b trial is designed to evaluate the efficacy and safety of intra-articular injections of Allocetra™ in patients aged 64 and older with moderate-to-severe age-related symptomatic primary knee OA, the population for which the U.S. Food and Drug Administration (FDA) granted RMAT designation. Key efficacy endpoints include changes from baseline in pain and function compared with placebo, measured at three and six months following treatment. Additional endpoints include changes in quality-of-life measures and functional mobility assessments.

Einat Galamidi, M.D., Chief Medical Officer of Enlivex, commented, "We are very excited by the progress of our Phase 2b trial. Reaching more than 70% of randomization in the trial reflects strong engagement from our investigators and patients across the United States and Europe. Our team is committed to executing this study to the highest standards of quality and in accordance with our stated timelines, and we look forward to reporting topline six-month data by mid-2027.

About Enlivex (Nasdaq: ENLV)

Enlivex is a quality longevity company powered by a prediction markets treasury. The Company is advancing Allocetra™, an advanced clinical-stage immunotherapy targeting inflammatory conditions associated with aging, with a primary focus on age-related osteoarthritis. In addition to its clinical programs, Enlivex operates a prediction markets treasury strategy built around the Rain protocol, the leading decentralized prediction markets infrastructure on Arbitrum. This dual strategy combines the development of quality longevity therapeutics with exposure to the emerging prediction markets ecosystem.

About Knee Osteoarthritis

Knee osteoarthritis (KOA) is one of the most prevalent and disabling diseases worldwide, affecting more than 32 million Americans today and projected to impact 78 million Americans by 2040. There are currently no approved disease-modifying therapies; treatment is largely limited to pain relief, intra-articular steroids, or surgery, and the burden increases sharply with age. By age 60, KOA affects roughly 30% of the population, and about half of knee OA patients are 60 years and older. This demographic is expanding with global aging trends, underscoring the need for new, durable therapies.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements may be identified by words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "would," "could," "intends," "estimates," "suggests," "target," "has the potential to," "goal," and other words of similar meaning, including statements relating to the anticipated benefits of the Company's digital asset treasury strategy; the assets to be held by the Company; the expected future market, price, trading activity, and liquidity of the RAIN token; the impact of expanded exchange listings and increased token liquidity on market participation and accessibility; the potential effects of digital asset liquidity on the liquidity of the Company's ordinary shares; macroeconomic, political, and regulatory conditions surrounding digital assets; the Company's plans for value creation and strategic positioning; market size and growth opportunities; regulatory conditions; competitive position; technological and market trends; future financial condition and performance; expected clinical trial results; market opportunities for the results of current clinical studies and preclinical experiments; and the effectiveness of, and market opportunities for, ALLOCETRA™ programs. Each forward-looking statement contained in this press release is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statement. Applicable risks and uncertainties include, among others, the risk of failure to realize the anticipated benefits of the Company's digital asset treasury strategy; changes in business, market, financial, political, and regulatory conditions; risks relating to the Company's operations and business, including the highly volatile nature of the price, trading volume, and liquidity of RAIN and other cryptocurrencies; risks associated with digital asset exchange listings, trading venues, and market infrastructure; the risk that the price and liquidity of the Company's ordinary shares may be correlated with the price or liquidity of the digital assets it holds; risks related to increased competition in the industries in which the Company operates; risks relating to significant legal, commercial, regulatory, and technical uncertainty regarding digital assets generally; risks relating to the treatment of crypto assets for U.S. and foreign tax purposes; and those risks and uncertainties identified in the Company's filings with the Securities and Exchange Commission. The forward-looking statements in this press release speak only as of the date of this document, and the Company undertakes no obligation to update or revise any of these statements, except as required by applicable law.

ENLIVEX CONTACT
Shachar Shlosberger, CFO
Enlivex Ltd.
shachar@enlivex.com 

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

How many patients have received Allocetra in Enlivex's Phase 2b knee osteoarthritis trial?

135 patients have been randomized and received their first injection, out of a planned 182. Recruitment remains active at clinical sites in the United States, Denmark and Poland.

When does Enlivex expect results from its Phase 2b Allocetra knee osteoarthritis trial?

Enlivex expects to report topline six-month data by mid-2027. The study evaluates safety and efficacy, with key efficacy measures comparing changes in pain and function against placebo at three and six months following treatment.