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.
As chief medical officer of Trek Therapeutics, a public benefit corporation, Robert Hindes, MD, heads a clinical team focused on developing affordable antiviral drugs for global markets. In June 2016, Robert Hindes, MD, and his company announced the start of a Phase 2a study of TD-6450 plus faldaprevir, with and without ribavirin, involving patients with genotype 1b (GT 1b) HCV infection at sites in the United States and New Zealand.
The new study follows the analysis of interim results for the same set of drugs being used to treat patients with HCV GT 4. The 16-patient study yielded successful results, with HCV RNA <LLOQ in all patients by Week 3 of treatment, and SVR in all 10 patients who have post-dosing results.
TD-6450 has been designed to provide better antiviral activity results with genotype 1 resistance-associated variants that are resistant to previously developed NS5A inhibitors, such as daclatasvir. Faldaprevir is a protease inhibitor that is highly active against HCV GT 1 and 4.
During his time with Pharmasset, Robert Hindes, MD, helped to develop the HCV drug Sovaldi and led the company’s clinical development program. When the company was purchased by Gilead Sciences, Robert Hindes, MD, temporarily joined the Gilead team in a transitional capacity before leaving to cofound his own company.
In late 2011, pharmaceutical company Gilead Sciences announced an agreement to purchase the smaller company Pharmasset for $137 per share, or roughly $11 billion in total. This represented nearly a third of Gilead’s total value at the time, making the purchase both risky and rather remarkable. Pharmasset, which had less than 100 employees at the time of purchase, was a small research-based company that was making significant progress with two different drugs meant to treat chronic hepatitis C (HCV).
Gilead Sciences and Pharmasset representatives agreed that the companies shared a common vision for the development of HCV treatments. At the time, Gilead was making progress with its own HCV treatments, but determined that acquiring the Pharmasset nucleoside polymerase inhibitors would help it compete on a higher level and bring effective therapies to the public even faster.
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.