Trek Therapeutics Looks to Launch New HCV Regimen by 2020

Trek Therapeutics pic

Trek Therapeutics
Image: trektx.com

Formerly the group director of virology at Connecticut-based Bristol-Myers Squibb, Robert Hindes, MD, now works at Trek Therapeutics in Cambridge, Massachusetts, where he serves as the chief medical officer. A co-founder of the company, Robert Hindes, MD, helps oversee Trek Therapeutics’ mission of treating undiagnosed hepatitis C worldwide.

Trek Therapeutics has an ambitious goal – to unveil a new cure for the hepatitis C virus (HCV) within the next two years. The company is targeting Mexico and countries in Central and Eastern Europe. These countries have a difficult time accessing traditional HCV treatments because they lie in the “middle-income” area and aren’t eligible for drastically reduced prices for medicine that are made available in impoverished areas.

Trek Therapeutics is working to develop an affordable regiment that does not produce the liver issues (damage, failure, cancer) that the current crop of drugs can cause. In its flagship trial, Trek Therapeutics was able to cure all the patients who took part in its new regimen, and the company is confident it will be ready to roll out the new treatment by 2020.

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Contracting the Hepatitis C Virus

Hepatitis C Virus pic

Hepatitis C Virus
Image: webmd.com

Robert Hindes, MD, started his career as an infectious diseases consultant at Danbury Hospital and New Milford Hospital in Connecticut. A co-founder of Trek Therapeutics, Robert Hindes, MD, now oversees the development of medicines to treat several acute and chronic viral infections.

Trek Therapeutics primary current focus is on treatments for the hepatitis C virus (HCV). The risk of contracting HCV can be reduced with common sense preventative measures:

1. Avoid exposure to blood. HCV usually spreads when the blood of an infected person enters the bloodstream of an uninfected individual. Individuals who work in the medical profession should wear protective clothing and gear that minimize the chance of direct contact with blood or body fluids.

2. Refrain from sharing personal care products. Razors and toothbrushes may spread the infection through razor cuts or bleeding gums. Even a small amount of blood can infect another person, so individuals should use their own personal care products.

3. Practice safe sex. 

4. Make sure that tattoos and piercings are administered by experienced practitioners using sterilized instruments. Tattoo and piercing parlors that fail to follow appropriate sanitary procedures can spread HCV through the use of contaminated needles. Conduct thorough research on parlors before you get a tattoo or piercing, and make sure the artist you choose can produce his or her license.

How Does Hepatitis C Spread?

 

Trek Therapeutics pic

Trek Therapeutics
Image: trektx.com

Robert Hindes, MD, has been engaged in clinical research in infectious diseases and virology for almost 3 decades. Starting with clinical, bench, and animal research during his fellowship at Harvard Medical School, Robert Hindes, MD, continued conducting research at Danbury Hospital, Bristol Myers Squibb, Pharmasset, and Gilead. He is currently based in Massachusetts, where he serves as the cofounder and chief medical officer of Trek Therapeutics.

Founded in 2014, Trek Therapeutics is a public benefit corporation that develops treatments for infectious diseases. Recently, the firm completed a Phase 2a randomized, double-blind trial investigating the combination of faldaprevir QD with TD-6450 QD plus ribavirin BID that achieved SVR4 in all subjects with genotype 4 HCV.

HCV, or hepatitis C virus, causes an infection of the liver that often leads to cirrhosis, liver cancer, and liver failure. The condition, which currently affects more than 2.7 million people in the United States, spreads when HCV-infected blood enters the bloodstream of a healthy person. Typically, HCV is spread through sharing needles, medical procedures with unsterilized equipment, and through unprotected sex between men. The virus may also spread during heterosexual sex or when toothbrushes, nail clippers, or razors are shared.

Goals of Phase II Clinical Trials

hepatitis C virus

 

Having previously functioned as an infectious disease consultant at Danbury and New Milford Hospital in Connecticut while teaching at Yale University and New York Medical College, Robert Hindes, MD, serves as the chief medical officer of Trek Therapeutics. In his leadership role with the pharmaceutical developer, Robert Hindes, MD, oversees Phase II clinical trials for a next-generation treatment for hepatitis C virus, with a plan to develop affordable drugs for patients without access to effective therapies..

The primary objective of Phase II clinical trials is to establish the safety and therapeutic efficacy of a drug. Most importantly, companies must use Phase II trials to demonstrate a measurable benefit to the patient. Drugs in Phase II trials must also produce a primary response in the intended target; for example, an anti-cancer drug must actually display anti-cancer properties. Finally, Phase II trials enable researchers to expand the toxicological and pharmacological data collected in Phase I.

In terms of structure, Phase II clinical trials typically recruit approximately 100 to 200 subjects, but this number varies greatly among studies. Due to the relatively small sample sizes, the success of drugs in Phase II trials is assessed by observed differences between the drug(s) being studied and the placebo or active control arm, and generally not by statistical comparisons. Commonly referred to as “pilot” studies or proof-of-concept studies, Phase II trials determine whether a drug is a good candidate for larger, statistically powered Phase III trials in a larger population.