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Enlivex (ENLV) Begins Phase IIb COVID-19 Study on Cell Therapy

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Enlivex Therapeutics Ltd. (ENLV - Free Report) announced that it has initiated dosing in a phase IIb study evaluating its off-the-shelf cell therapy, Allocetra, for treating patients with severe and critical COVID-19 with acute respiratory distress syndrome.

The multi-center, placebo-controlled mid-stage study will recruit around 152 severe/critical COVID-19 patients at centers in Israel and certain European countries. The study will investigate the safety and efficacy of Allocetra when administered in addition to standard-of-care treatment. Top-line data from the same is expected in the second quarter of 2022.

The co-primary endpoints of the study are to check the ventilation-free survival and recovery for its two patient sub-populations — severe and critical. The study will also assess the long-COVID-19 symptoms in this patient population, which are the secondary endpoints.

Shares of Enlivex have rallied 35.1% so far this year against the industry’s decrease of 12.5%.

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Per the company, Allocetra has the potential to address an area of unmet medical need for COVID-19 patients in severe or critical condition.

Apart from addressing COVID-19, Allocetra is also being developed for treating several other life-threatening diseases.

A phase IIb study is currently evaluating Allocetra for treating patients with pneumonia-associated sepsis. Top-line data from this study is expected in the second quarter of 2022.

Enlivex plans to begin a phase Ib study on Allocetra in combination with chemotherapy for treating solid peritoneal tumors, in the fourth quarter of 2021. The company also plans to start a phase Ib study evaluating Allocetra in combination with an immune checkpoint inhibitor, in the first half of 2022.

We note that Enlivex has no approved product in its portfolio at the moment. Hence, successful development of Allocetra remains in key focus for the company.

Zacks Rank & Other Stocks to Consider

Enlivex currently carries a Zacks Rank #2 (Buy). Some top-ranked stocks in the drug/biotech sector include Regeneron Pharmaceuticals, Inc. (REGN - Free Report) , Ironwood Pharmaceuticals, Inc. (IRWD - Free Report) and Collegium Pharmaceutical, Inc. (COLL - Free Report) , all sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

Regeneron’s earnings estimates have been revised 19.8% upward for 2021 and 14.2% upward for 2022 over the past 60 days. The stock has surged 34% year to date.

Ironwood’s earnings estimates have been revised 18% upward for 2021 and 43.3% upward for 2022 over the past 60 days. The stock has rallied 10.7% year to date.

Collegium’s earnings estimates have been revised 41.6% upward for 2021 and 36.6% upward for 2022 over the past 60 days.