A group of Israeli researchers have launched a Phase II study of a drug that they believe could keep patients off mechanical ventilation and speed their recovery.
The trial, which is being collectively run by Ziv and Rambam medical centers with researchers from Bar-Ilan University and Technion-Israel Institute of Technology, is examining the use of a drug based on a naturally occurring peptide called angiotensin 1-7 to help counter the impact of COVID-19 on the lungs.
A peptide is a set of amino acids.
Coronavirus enters a person’s cells through angiotensin-converting enzyme 2 (ACE2) receptors. These same receptors produce angiotensin 1-7, explained Dr. Karl Skorecki, dean of the Azrieli Faculty of Medicine of Bar-Ilan University in the Galilee. Angiotensin 1-7 is a protein that is naturally produced in the body and is responsible for preventing cell proliferation and inflammation.
“When the enzyme is busy acting as a receptor, it can no longer do what it is supposed to do, which is make angiotensin 1-7,” Skorecki said. “The hope is that by replenishing this peptide, their lungs will get back what the virus nefariously took away from them.”
Around 3% of all people who contract coronavirus in Israel are hospitalized, and many do not respond to what have become traditional steroid or antiviral drug treatments.
The trial is using TXA127, a pharmaceutical formulation of angiotensin 1-7 developed by the US company Constant Therapeutics LLC.
The CEO of the company, Rick Franklin, said that “I am proud of my Jewish roots and of partnering with Rambam, Ziv, Bar-Ilan and the Technion, which are world-renowned institutions.”
Because the protein is a biological substance, the likelihood of it causing side effects is low, according to Skorecki.
The Phase II trial was approved by the Health Ministry and will involve 120 hospitalized COVID-19 patients whose condition is defined as moderate. Sixty patients will receive the treatment and 60 a placebo.
So far, more than a dozen patients have enrolled in the trial.
The idea to test angiotensin 1-7 was generated by the Prof. Zaid Abassi, staff scientist at Rambam Health Campus.
“I thought if there was a decrease in this enzyme in the body, maybe external administration of the protein would prevent the complications caused by coronavirus, with an emphasis on improving lung damage,” Abassi explained. “Once the idea came up, a race against the clock began.”
Skorecki said the hope is that the trial will be completed in the next two to four months.
Coronavirus mutations would not affect the effectiveness of treatment, according to Rambam’s Dr. Etty Kruzel.
“We are so confident in the results that [Constant Therapeutics] is already recruiting partners to prepare for global manufacturing and distribution.”