The company said that it values the FDA’s feedback and is happy that the agency has accepted its request to provide insights on its Hepatitis B development program.
Los Angeles-based biopharmaceutical firm Enochian BioSciences has announced that it has gotten a green light from the U.S. Food and Drug Administration (FDA) for feedback on a possible cure for infections caused by the hepatitis B virus (HBV).
In a statement, the company said that it values the FDA’s feedback and is happy that the agency has accepted its request to provide insights on its Hepatitis B development program. Written comments on the pre-IND (Investigational New Drug) request are expected in the fall.
The request sprang forth after Enochian’s trials on chimeric mice yielded promising results. Scientific experts regard chimeric mice as the gold standard amongst animal models to assess HBV’s effectiveness.
The fact that Enochian’s testing efforts using these mice had led to positive results bodes well for its future in finding a cure for Hepatitis B and a wide range of diseases that have yet to find a solid solution. HBV is a disease that causes chronic liver damage in over 350 million worldwide, killing as many as one million annually.
“We are encouraged by the novel mechanism of action, called Hijack RNA, that shows promise as a potential platform technology for coronaviruses, including the cause of COVID-19, influenza, and HBV, and exploring its use against HIV,” said Dr. Mark Dybul, executive vice chairperson of the board at Enochian BioSciences.
In the same press release, Dr. Carol Brosgart, clinical professor of medicine, epidemiology, and biostatics at UCSF and board director at Enochian, called the results on the chimera mice “impressive,” adding that this news offers great hope that science is on track to finally develop a commercially available product that can cure HBV infection.
In late June 2021, Enochian BioSciences revealed that its innovative cellular therapy, Hijack RNA, has shown the ability to trick viruses into using proteins necessary to reproduction. This triggers the infected cells to die instead of turning into virus makers. Enochian has the exclusive license to use the Hijack RNA approach as a possible way to treat or prevent any variant of coronaviruses or influenza. It is also currently developing the same approach to treat or cure HIV.
“Combined with the promising results from studies to treat or prevent any coronavirus or influenza virus, the data also offers hope that Hijack RNA could be a powerful platform technology to combat some of the most devastating diseases in the world,” said Dr. Dybul in a separate statement.
As for HBV, Enochian found that the virus could no longer be detected in the chimera mice on the eight day of treatment and that no toxicities in the liver and other tissues were observed. Findings from this study were presented at the International Liver Conference.
