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.

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Nucleotide Analogs for the Treatment of Hepatitis C Virus

Trek Therapeutics pic

Trek Therapeutics
Image: trektx.com

A graduate of Rutgers New Jersey Medical School, Robert Hindes, MD, has dedicated over two decades to the study of infectious diseases. He currently oversees the clinical development of innovative hepatitis C medications as chief medical officer at Trek Therapeutics, having previously served as vice president of clinical development at Pharmasset. In that role, Robert Hindes, MD, played a leading role in the development of a nucleotide analog for hepatitis C virus (HCV), which resulted in breakthrough drug regimens for the treatment of the highly prevalent infectious disease.

Nucleotides are one of the key building blocks of the human body. Each comprising a five-carbon sugar, a nitrogenous base, and one or more phosphate groups, the molecules combine in linear polymers to form nucleic acids such as DNA and RNA. Nucleotides indirectly play a role in the fight against infectious diseases.

Certain antiviral drugs, known as nucleotide analogs, are designed to appear to viruses as nucleotides. Because nucleotide analogs have the potential to stop viruses from replicating, they have contributed to effective therapies for viral diseases including HIV and herpes. In the case of HCV, nucleotide analogs can facilitate chain termination regardless of the HCV genotype, encouraging viral suppression while limiting viral resistance. While this strategy amounts to suppressive therapy in the case of HIV, herpes, and hepatitis B, the combination of viral suppression and a high barrier to resistance, along with unique properties of the hepatitis C virus, allow patients with HCV infection to be cured.