Israeli immunotherapy company Enlivex Therapeutics (Nasdaq: ENLV) reported positive interim results of a Phase II clinical trial of its Allocetra product in severe and critical Covid-19 patients.
The interim clinical results relate to eight Covid-19 patients who were treated with Allocetra, six of whom were in severe condition and two of whom were in critical condition. Seven completely recovered and were discharged from the hospital, after an average of 4.7 days following Allocetra administration. The eighth treated patient in the Phase II study has experienced a clinical improvement following treatment with Allocetra and is currently classified as moderate/severe condition . The company says that the Allocetra treatment has been well tolerated with no treatment-related serious adverse events.
Allocetra is designed to treat the severe condition in which the immune system itself attacks the body. At this stage, the virus that caused the disease may no longer be active or even present in the body, but the immune reaction cannot be stopped. Enlivex's product was developed control the immune system and prevent it from running wild. It was originally developed to deal with sepsis following other infections, before the coronavirus pandemic hit, but the immune system works in a similar way irrespective of the source of infection.
If the current results added to previous ones in the company's trial, twelve patients have completely recovered after being treated with Allocetra.
The product will still need to undergo a controlled trial, since in a trial with no control group in a small hospital it is not possible to know how many patients would have recovered by themselves. Nevertheless, the results from twelve patients who were in severe to critical condition and were genuinely chosen at random, in that it could not be predicted that they would recover, seem promising.
Enlivex's share price is up 26%, giving it a market cap of $140.5 million. The share price fell 30% after the results were announced of the successful trials of vaccines by Pfizer and Moderna, which changed the projections of the future course of the coronavirus pandemic. Enlivex's share price is now rising again, making up most of the drop.
Enlivex CEO Oren Hershkovitz said, "We believe that Allocetra, if approved, could potentially cover the void that currently exists in treatments for severe or critical Covid-19 patients. The upcoming anticipated regulatory approval of various Covid-19 vaccines is a game-changer in the fight against the pandemic, yet with various surveys demonstrating 33% of the US population unwilling to get vaccinated, and studies showing that vaccines are not 100% effective, our commercial model estimates continued demand for the treatment of severe or critical Covid-19 patients for years to come."
Published by Globes, Israel business news - en.globes.co.il - on December 3, 2020
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