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.

Examining the Causes of Hepatitis C

 

Hepatitis C pic
Hepatitis C
Image: webmd.com

Robert Hindes, MD, served as the group director of virology at Bristol-Myers Squibb, which is based in Wallingford, Connecticut, prior to taking in his role as the chief medical officer of Trek Therapeutics. Focusing on the development of affordable hepatitis C (HCV) drugs that are accessible to the largest possible audience, Robert Hindes, MD, oversees the development of all clinical strategies employed by Trek Therapeutics.

A viral condition, HCV is transmitted when a person comes into contact with the blood or other bodily fluids of somebody who carries the infection. Blood, however, is the main transmitter, as even small traces of it are capable of passing on the infection. Some believe the virus is capable of surviving in blood outside of the human body for a number of weeks in areas that remain at room temperature.

The predominant cause of the infection is the sharing of needles by drug users; for instance, the NHS, the United Kingdom’s public health service, estimates the practice to be the cause of around 90 percent of infections in that country. Less common causes include unprotected sex, particularly amongst people who have other sexually transmitted infections such as genital sores or HIV. There is also the potential for HCV to be passed to others if items that come into contact with blood (such as tattoo equipment, needles, razors, and scissors) have not been properly sterilized before use.

There is also an estimated 5 percent chance that the infection can be passed from mother to child, though it is believed that this cannot occur through breastfeeding.

Barriers to Treatment in Patients With c

Chronic Hepatitis C  pic
Chronic Hepatitis C Treatment
Image: trektx.com

Robert Hindes, MD, co-founded Trek Therapeutics in 2014 and serves as the pharmaceutical company’s chief medical officer. At Trek, Robert Hindes, MD, has focused his efforts on developing affordable therapies for patients with chronic hepatitis C.

For many people living with hepatitis C (HCV), dealing with the disease itself is only part of the struggle. Treatments exist for most genotypes of HCV, but these therapies are so expensive and so hard to access that many patients cannot obtain the medical care they need.

Historically, HCV therapies that included interferon required long durations of treatment, brought debilitating side effects, and cured fewer than half the patients who received drug therapy. Many patients avoided treatment because of the side effects and relatively low cure rate of the drug combinations available. Now that safer and more effective treatments are available, many patients cannot afford or have no access to the newer HCV drugs. Pharmaceutical companies and patient advocate groups have recently begun to work together to find a solution for this problem. However, it is likely that access to affordable and effective drug therapies will continue to be unavailable to a large number of patients for at least the next several years, and it is hoped that the drugs being developed by Trek will help to address this unmet medical need.

New Study From Trek Therapeutics Tests TD-6450 and Faldaprevir

 

Trek Therapeutics pic
Trek Therapeutics
Image: trektx.com

As the co-founder and chief medical officer of Trek Therapeutics, Robert Hindes, MD, is responsible for designing and managing clinical studies evaluating Trek’s hepatitis C drugs. Robert Hindes, MD, and Trek have recently been focused on trials involving TD-6450 and faldaprevir, two of the company’s most promising in-licensed assets.

In mid-June, Trek Therapeutics began a new study to evaluate the effectiveness of TD-6450 plus faldaprevir against HCV genotype 1b. The study will measure the regimen’s effectiveness both with and without the addition of ribavirin, an antiviral commonly used to treat HCV. These trials are being conducted in both New Zealand and the United States.

Trek’s next generation NS5A inhibitor, TD-6450, is an essential component in the combination drug regimen. TD-6450 was designed to perform better than similar antivirals, especially against the particular strains that were resistant to first generation NS5A inhibitors. So far, TD-6450 and faldaprevir results have been very encouraging, demonstrating rapid and sustained suppression of HCV. If all goes well, these new treatments may be able to improve quality of life for people infected with HCV but with poor access to the expensive regimens being marketed in the US and Europe.