A new oral treatment for the coronavirus that could be given to patients that test positive for COVID-19 before they are hospitalized has been announced. It could also protect high-risk individuals and frontline health care workers.
The drug, developed by US-based biotechnology company Tyme Technologies, is made from synthesized antiviral bile acid and has proved efficient at fighting COVID-19 in preclinical trials, the firm said.
Tyme has been developing the drug, named TYME-19, since the onset of the pandemic, and has partnered with doctors from the Massachusetts General Hospital and the Weill Cornell Medical Center for drug trials.
“There is an incredible need for patients after diagnosis for a safe treatment that would alleviate their symptoms and eliminate the need for them to go to a hospital. Currently, most of therapeutic drug development is focused on hospitalized patients,” Dr Curtis Cetrulo Jr., of Massachusetts General Hospital and Harvard Medical School said in a statement.
While in preclinical testing, TYME-19 was repeatedly shown to prevent COVID-19 from replicating in treated cells without causing damage, the firm said. Previous research has also demonstrated that TYME-19 could be used as an effective treatment against other viruses, included other coronaviruses like SARS or MERS, and others, including influenza, hepatitis, and West Nile virus.
“We are encouraged with this new approach to fight COVID-19, especially one in a class of therapies that has a well understood safety profile and considerable research behind it. We are also hopeful that TYME-19’s potential broad antiviral properties could help us prepare for future outbreaks,” Cetrulo continued.
Viruses attack the ability of the body’s cells to make proteins and lipids, instead using this process to replicate itself. TYME-19 has been shown to prevent this process, the company said.
“The demonstrated tolerability of this agent and the multiple antiviral mechanisms of TYME-19, make it an exceptional potential treatment against a virus that spreads rapidly, like COVID-19,” Dr. John Rothman, the executive vice president of product development at Tyme said.
“TYME-19 is a synthetic bile acid with numerous therapeutic effects, including broad spectrum antiviral activity that has yet to be exploited. Its ability to inhibit viral replication leaves open the question of whether it may not just be a potential therapy for early stage disease but may also be a prophylactic therapy,” he explained.
The next step
The company says that the next step will be a proof-of-concept study to evaluate the new treatment by comparing it to a placebo in newly diagnosed patients of COVID-19 that are classified as high-risk.
Should the results come back positive, a development program may be put in place to study TYME-19 as an oral treatment for patients with COVID-19 and as a preventative measure for high-risk individuals and front-line workers.
“We hope that TYME-19 can soon be an important treatment alternative for doctors in the fight against COVID-19 … we believe metabolic agents have been largely overlooked for their potential as innovative therapies that could save lives, change the course of care and ultimately reduce the burden on healthcare systems,” Steve Hoffman, the chairman and CEO of Tyme said in the statement.