Trek Therapeutics Announces Oral Presentation of Faldaprevir, TD-6450 and Ribavirin Ph2a Trial Results at the Asian Pacific Association for the Study of the Liver on February 18, 2017 in Shanghai

CAMBRIDGE, Mass., Feb. 13, 2017 -- Trek Therapeutics, PBC announced today that results from an ongoing Phase (Ph) 2a clinical trial to evaluate all-oral combination regimens to treat hepatitis C virus (HCV), containing faldaprevir (FDV), TD-6450, and ribavirin (RBV), will be orally presented at the Asian Pacific Association for the Study of the Liver (APASL) conference in Shanghai, China on February 15-19, 2017.

The abstract entitled “Development of an Affordable and Accessible HCV Treatment: Phase 2a Study TRK-450-0201 Demonstrates Favorable Efficacy, Safety, and Pharmacokinetics of Faldaprevir+TD6450+Ribavirin in Patients with Genotype 4 HCV Infection” will be presented by Dr. Tarek I. Hassanein at Oral Presentation 18/Viral Hepatitis C - Therapeutics: New Agents 1 on Saturday, February 18 at 15:55. In this Ph2a study, 16 genotype (GT) 4 subjects without cirrhosis were randomized 1:1 in a blinded fashion and treated for 12 weeks with 60 or 120 mg TD-6450 in combination with FDV 120 mg and RBV. SVR12 was achieved in all 16 patients, and treatment with FDV, TD-6450 and RBV was well-tolerated. Ph2a studies evaluating the effectiveness of FDV+TD6450 ± RBV in patients with GT1b HCV are now ongoing.

Development of affordable therapies for HCV is a global health priority. Multiple highly effective, safe and well-tolerated curative regimens have been developed for chronic HCV, and the creation of these drugs sets the stage for a Campaign to Eradicate HCV. Unfortunately, the accessibility of HCV treatment is limited by the low diagnosis rate and the high cost of drugs in many regions, especially in middle-income countries. Trek Therapeutics is developing an affordable and accessible treatment regimen that combines FDV, a protease inhibitor and TD-6450, an NS5A inhibitor, to be used in combination with other HCV antivirals.

About HCV
The hepatitis C virus is one of the most common causes of viral hepatitis, which is an inflammation of the liver. It is currently estimated that more than 150 million people are infected with HCV worldwide including over 4 million people in the United States. Most of the global HCV patient population is undiagnosed; it is a silent epidemic and a major global health threat. Chronic hepatitis, if left untreated, can lead to permanent liver damage that can result in the development of liver cancer, liver failure or death. Despite available treatments, there remains a significant unmet need for many patients infected with HCV.

About Faldaprevir
Faldaprevir is a well-characterized HCV protease inhibitor licensed from Boehringer Ingelheim. Ph3 studies evaluating FDV in combination with pegylated interferon and RBV have been completed by Boehringer Ingelheim.

About TD-6450
TD-6450 is a multivalent NS5A inhibitor licensed from Theravance Biopharma, Inc.

About Trek Therapeutics
Trek Therapeutics, PBC is a private, clinical stage public benefit corporation developing treatments for serious infections. Its mission is to profitably develop affordable and accessible medicines to treat infectious diseases and to commercialize them for global populations. TREKtx is currently conducting Ph2 clinical trials in patients with chronic HCV infection using a combination of direct acting antivirals, and is also evaluating treatments for other infectious diseases. For further information, please visit www.trektx.com.

Contact:
Jane A. Kramer  
[email protected]
781-799-9524