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TYME Says Oncology Research 'Reveals Potential New Oral Therapy TYME-19 in the Fight Against COVID-19'; Highlights 'a potential new approach to treating COVID-19 using a metabolic agent'

TYME-19 is an oral synthetic bile acid that has demonstrated broad spectrum antiviral activity as well as efficacy against COVID-19 in preclinical studies Initiating proof-of-concept RESPOnD trial to investigate

  • TYME-19 is an oral synthetic bile acid that has demonstrated broad spectrum antiviral activity as well as efficacy against COVID-19 in preclinical studies
  • Initiating proof-of-concept RESPOnD trial to investigate TYME-19 for safety and efficacy in recently diagnosed, symptomatic COVID-19 patients
  • RESPOnD trial is being led in collaboration with investigators from Massachusetts General Hospital and Weill Cornell Medical Center
  • Trial is targeted to begin as soon as customary clinical trial site approvals are completed
  • TYME-19 is intended to be a well-tolerated therapeutic that could be used at earlier stages of COVID-19 infection and in future viral outbreaks

Tyme Technologies, Inc. (NASDAQ:TYME), an emerging biotechnology company developing cancer metabolism-based therapies (CMBTsTM), announced a potential new approach to treating COVID-19 using a metabolic agent, TYME-19. TYME-19 is a synthetic bile acid, a family of metabolic agents that the Company also uses in its anticancer product, TYME-18. Because of its expertise in metabolic therapies, the Company was able to quickly identify TYME-19 as a potent, well characterized antiviral bile acid and has performed preclinical experiments establishing effectiveness against COVID-19. Bile acids have primarily been used for liver disease; however, they represent a family of critical cellular regulators across cardiovascular, neurologic, and metabolic systems, with some also having antiviral properties.

TYME has partnered with physicians from Massachusetts General Hospital and the Weill Cornell Medical Center to design a trial for recently diagnosed, symptomatic patients. The proof-of-concept trial is expected to start as soon as customary trial site approvals are completed.

"There is an enormous unmet medical 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," said Curtis L. Cetrulo, Jr., M.D. of Massachusetts General Hospital and Harvard Medical School. "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."

In preclinical testing, TYME-19 repeatedly prevented COVID-19 viral replication without attributable cytotoxicity to the treated cells. Previous preclinical research has also shown select bile acids like TYME-19 have had broad antiviral activity. TYME-19 is part of a family of metabolic agents called bile acids that have formerly been associated with liver disease but are becoming 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 systems1,2. TYME is a leader in the development of bile acids as potential therapies for cancer, COVID-19 and other diseases.

TYME and its collaborating partners at Massachusetts General Hospital and Weill Cornell Medical Center are initiating a proof-of-concept study to evaluate TYME-19 versus placebo in newly diagnosed, symptomatic patients with defined high-risk factors. The trial will measure specific indicators of safety and efficacy, including time to resolution of symptoms, changes in viral load, rate of hospitalization and others. 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.

Viruses hijack a cell's ability to make proteins and lipids and divert these processes to make viral proteins and lipids in order to reproduce. Viruses accomplish this by inducing stress in the endoplasmic reticulum (ER), where cells process proteins, which enables the virus to remodel protein and lipid synthesis. In preclinical testing, TYME-19 has been shown to counteract these effects, preventing viral replication, by reducing ER stress3,4. 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.

"The demonstrated tolerability of this agent, the multiple antiviral mechanisms of TYME-19, and the recent finding that certain bile acids occur naturally as part of our response to viral infection, make it an exceptional potential treatment against a virus that spreads rapidly, like COVID-19," said Dr. John Rothman, Executive Vice President, Product Development at TYME. "Although bile acids have traditionally been developed for hepatic disease, they have recently been recognized as steroid hormones with broad metabolic functions in the body including neuro- and cardio-protective roles, as well as antiviral properties. 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."

Beyond TYME-19, TYME is utilizing its experience in cell metabolism to identify a pipeline of proprietary oral compounds that are designed to have improved antiviral efficacy for use against COVID-19 and future viral outbreaks.

"We hope that TYME-19 can soon be an important treatment alternative for doctors in the fight against COVID-19," said Steve Hoffman, TYME's Chairman and CEO. "We chose TYME-19 because of its similarity to our metabolic cancer agent TYME-18, the breadth of research, its ease of manufacturing and oral administrability. Moreover, 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. At the same time, we remain committed to our cancer metabolism-based development programs and we will continue to follow the science to where we can improve the lives of patients in need."