Last week, US-based biotechnology company Tyme Technologies announced a new oral treatment for the coronavirus that could prove pivotal in the fight against COVID-19.
The drug, named TYME-19,could be given to patients that test positive for COVID-19 before they are hospitalized, and could also be taken by front line health care workers and high-risk individuals to minimize the chance of infection, said a representative from Tyme Technologies.
TYME-19 is made from synthesized antiviral bile acid and has proved efficient at fighting COVID-19 in preclinical trials, the firm said at the time. Tyme Technologies partnered with doctors from the Massachusetts General Hospital and the Weill Cornell Medical Center for clinical trials of the drug.
“TYME-19 is the only agent in this class of metabolic-based medicines derived from bile acids. It has a unique mechanism of action modeled after the body’s own defenses against virus infection. TYME-19 is oral and instant, differing from all injectables including vaccines,” Steven Hoffman, co-founder, chief executive, and chief science officer of Tyme Technologies told Al Arabiya English on Wednesday.
Here’s everything you need to know about the new treatment:
Does TYME-19 stop the coronavirus?
So far, preclinical trials have proven successful, with TYME-19 stopping COVID-19 from replicating in treated cells without causing damage.
“In preclinical testing, TYME-19 repeatedly prevented COVID-19 viral replication without cytotoxicity in treated cells. Previous preclinical research has also shown select bile acids like TYME-19 have had broad antiviral activity,” Hoffman added.
However, Hoffman added that further testing is necessary, and highlighted the importance of the firm’s partnership with Massachusetts General Hospital and Weill Cornell for further testing opportunities. A new proof-of-concept study is set to take place to evaluate the effectiveness of TYME-19 versus a placebo in newly diagnosed patients with high-risk factors. The study is set to take place before the end of 2020.
“Positive results from the proof-of-concept study could lead to a development program in which TYME-19 is studied as a potential new oral treatment for patients with COVID-19 before they require hospitalization, and/or as prophylaxis for high-risk individuals and front-line workers,” Hoffman explained.
How was TYME-19 developed?
Tyme Technologies developed TYME-19 based on experience the firm had in developing a different type of bile acid, TYME-18, for its anticancer products.
“TYME-19 is part of a family of metabolic agents called bile acids that have previously been associated strictly with liver disease but recently are recognized for their potential utility to treat multiple diseases. Bile acids are important regulators for many cellular functions throughout the central nervous, cardiovascular and metabolic systems,” Hoffman said.
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 viruses from doing so, Hoffman went on to explain.
“In preclinical testing, TYME-19 has been shown to counteract these effects, preventing viral replication, by reducing ER stress. In addition, TYME-19 is believed to physically degrade viruses by solubilizing the protective lipid layer and other structural components, which prevent a virus from binding to and infecting a cell,” he said.
How is TYME-19 different from other COVID-19 medications in development?
Hoffman highlighted the company’s belief in TYME-19's safety as a COVID-19 drug, noting that it can be taken orally and is stable at room temperature – thus lowering the risk of the drug degrading through improper care.
TYME-19 will also be “relatively inexpensive to manufacture,” Hoffman said – an important factor to consider given the global need coronavirus treatment. The drug can also help protect front line health workers and high-risk populations, crucial to slowing the spread of the virus before a cure and vaccine can be developed, he said.
“Doctors need more tools between hospital care and vaccines. Until there is a cure (not just a vaccine), doctors will need multiple medicines for their treatment regimen … Vaccines are a key part of the solution for a pandemic, but there needs to be better therapies available while the vaccines are being developed,” Hoffman added.