Mission & Strategy
Trek Therapeutics (TREK) is a novel public benefit corporation whose mission is to rapidly and efficiently develop proprietary affordable treatments for infectious diseases. Our strategy is to launch a cure for hepatitis C virus (HCV) in 2020 and then to expand into other infectious diseases with high-unmet medical need. HCV is a global epidemic with 135 million infections worldwide.
Life-saving HCV drugs have been developed that can significantly decrease the increased risk that patients have for liver failure, liver cancer, and death. Unfortunately, high drug prices and/or rationing and poor medical infrastructure prevent many patients from getting treated. TREK is helping to eradicate HCV by profitably creating an affordable and accessible HCV treatment for 45 million patients in middle-income countries who do not have access to life-saving HCV drugs. Our initial launch target is Central and Eastern Europe (CEE) and Mexico, followed by South America and out-licensing in Russia, Ukraine, and China.
TREK has made significant progress toward launching our first HCV regimen in 2020. In less than 2 years, we have acquired 4 HCV drugs, started two mid-stage clinical studies, and cured 100% of the patients in our first clinical trial. If successful, we hope that TREK will serve as a model for other disease areas with limited access to high-priced drugs.
TREK has begun to develop two HCV combination therapies for different patient populations. Our goal is to achieve a good safety and efficacy profile (SVR of ≥ 95%) and treatment duration of 12 weeks or less.
- Faldaprevir is a HCV protease inhibitor acquired from Boehringer Ingelheim.
- TD-6450 is a HCV NS5A inhibitor acquired from Theravance Biopharma.
- VX-222 is a non-nucleoside inhibitor of the HCV polymerase acquired from Vertex Pharmaceuticals.
- VX-497, acquired from Vertex Pharmaceuticals, is an IMPDH inhibitor which is a broad spectrum antiviral drug. TREK has filed a use patent for VX-497 and VX-944 antiviral activity alone and in combination with RBV against 3 hemorrhagic fever viruses - Ebola, Lassa, and Junin. Zika antiviral activity has been demonstrated in vitro.
- MIV-802 is a preclinical nucleotide inhibitor of HCV polymerase acquired from Medivir AB.
Triple combination therapy achieves 100% SVR4 in Genotype 4 HCV patients
In October 2015, TREK began a Phase 2a randomized, double-blind trial to investigate the safety and efficacy of 120 mg faldaprevir QD in combination with 60 mg or 120 mg TD-6450 (NS5A inhibitor) QD plus ribavirin BID for 12 weeks in treatment-naïve, non-cirrhotic patients chronically infected with genotype (GT) 4 HCV. In September 2016 we announced interim results of the study. There were no serious adverse events or treatment discontinuations, and the majority of adverse events were mild. The most common adverse events observed in greater than 10 percent of patients across the study were fatigue, headache, and nausea. One hundred percent (100%, 16/16) of patients had HCV RNA below the lower limit of quantitation (<LLOQ, 15 IU/mL) after 3 weeks of treatment, and all 16 patients achieved SVR 4. To date, the 11 patients who have been followed for 12 weeks post-treatment have all achieved a sustained viral response (SVR12). No patients experienced virologic breakthrough or relapse.
Trek Therapeutics is currently conducting studies evaluating FDV plus TD-6450 with and without RBV in patients with GT1b HCV in New Zealand and the United States. Phase 2b studies are planned in 2017.
Compassionate Use Policy
Trek Therapeutics (TREK) is currently conducting Phase 2 clinical trials in patients with chronic hepatitis C virus (HCV) infection using a combination of direct acting antivirals. Since there are several approved drugs available for the treatment of HCV, TREK does not currently offer investigational drugs for compassionate use. We will be periodically evaluating this policy as our other research programs progress through preclinical and clinical development. If and when TREK provides compassionate use for a particular investigational drug, we will review each individual request for compassionate use and respond to the physician making the request via [email protected] within five (5) business days.