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.
Robert Hindes, MD, co-founded Trek Therapeutics, which is organized as a public benefit corporation that seeks ways of developing innovative yet affordable and accessible antiviral medications. As chief medical officer, Robert Hindes, MD, is engaged with his team in Phase 2a studies of TD-6450 plus faldaprevir.
Faldaprevir, a second generation protease inhibitor, was initially developed for use with ribavirin and pegylated interferon, and it is currently used in new regimens that are interferon-free. In phase 2b and 3 studies in patients with previously untreated genotype 1b hepatitis C virus (HCV), faldaprevir combined with pegylated interferon and ribavirin resulted in SVR rate of 82%.
A 2015 paper published in Liver International evaluated the Phase 2b SOUND-C2 interferon-free study involving a combination of faldaprevir, ribavirin, and deleobuvir. The combination resulted in overall SVR rate of 92%, and was well-tolerated among patients with HCV genotype-1a and 1b. Along with simeprevir, faldaprevir is considered one of the most effective second generation protease inhibitors.
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.
As vice president of clinical development for Pharmasset, Robert Hindes, MD, played an important role in the development of sofosbuvir, known now as Sovaldi. When the small company was acquired by Gilead Sciences, the nucleoside polymerase inhibitor that Robert Hindes, MD, evaluated in combination with other drugs, continued to be evaluated in clinical trials conducted by Gilead.
In early 2016, the FDA granted priority status to a new drug application (NDA) from Gilead Sciences. This new drug is sofosbuvir/velpatasvir, a combination of a polymerase inhibitor and a next generation NS5A inhibitor. If approved, the fixed-dose combination is expected to be active against all HCV genotypes.
Placebo-controlled trials demonstrated the pan-genotypic activity of the drug, and it expected to be a more effective alternative to Harvoni in patients with non-GT1 HCV. Another recent trial showed 95 percent SVR for patients who have both HCV and HIV.
Sofosbuvir/velpatasvir received the designation of breakthrough therapy from the FDA, meaning the agency recognizes its potential for widespread use and major advances in the treatment of hepatitis C.