Enlivex CEO outlines roadmap after knee arthritis trial results

Enlivex Therapeutics Ltd. (NASDAQ: ENLV) CEO Oren Hershkovitz issued a shareholder letter detailing the company's strategic roadmap following Phase IIa trial results for its Allocetra treatment in knee osteoarthritis patients.

The Phase IIa trial showed statistically significant improvements in pain and function among patients aged 60 and older with primary osteoarthritis. In this patient group, representing 54% of study participants, Allocetra demonstrated a 72% reduction in pain versus placebo and 109% improvement in function compared to the control group.

The company reported that patients in the Allocetra arm experienced a 49% absolute reduction in pain from baseline and 50% absolute improvement in function. The treatment was well tolerated with no drug-related serious adverse events, according to the press release.

Enlivex plans to release six-month data from the ongoing Phase IIa trial in November 2025. The company expects regulatory approval of its Phase IIb protocol in the first quarter of 2026, with first patient dosing planned for the second quarter of 2026. Three- and six-month topline data from the Phase IIb trial are expected in the second to third quarter of 2027.

The Phase IIa study enrolled 130 patients initially, with provisions to add up to 50 additional patients. The trial evaluates joint pain and function compared to placebo at three, six and 12 months post-treatment.

Knee osteoarthritis affects more than 32 million Americans, with projections indicating 78 million Americans will have the condition by 2040. The prevalence increases with age, affecting 30% of the population by age 60. Currently, no disease-modifying treatments are approved for the condition.

The company stated it is pursuing partnership opportunities with larger companies and non-dilutive funding based on the trial results.

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