Investing.com -- The FDA has granted Regenerative Medicine Advanced Therapy designation to Enlivex's experimental immunotherapy Allocetra for age-related knee osteoarthritis, Investing.com has learned.

The designation applies to Allocetra's use in patients aged 64 and older with symptomatic knee osteoarthritis, and is expected to give the biotech company more frequent, early-stage access to the FDA as it moves the therapy through its Phase IIb trial.

RMAT status can also open the door to accelerated approval and priority review, potentially shortening the path to market.

The designation is said to reflect confidence in data from Enlivex's completed Phase I/IIa trial, in which patients with primary age-related knee osteoarthritis treated with Allocetra showed statistically significant improvements in pain and physical function compared with placebo, with effects that held up for at least six months.

The company noted a potential pathway to expedite development of a treatment for a condition affecting "a large and growing aging population with limited treatment options."

The company has since launched a randomized, controlled Phase IIb trial across the U.S. and Europe, aiming to enroll 182 patients aged 64 and older with primary knee osteoarthritis. The first U.S. patient has already been dosed, and Enlivex expects top-line data by the end of the second quarter of 2027.

The FDA has also requested a Type B meeting with the company to discuss the broader Allocetra development program, including elements of its Phase IIb and pivotal trial planning, which Enlivex intends to schedule in the coming months.

More than 32 million Americans currently live with Knee osteoarthritis, a figure projected to climb to roughly 78 million by 2040. Current treatment options are limited, with severe cases often requiring total knee replacement.