August 2, 2017 – During  a presentation that included an overview of Trek’s current business and clinical strategy to develop treatments for hepatitis C virus (HCV) infection, at the Summer Edition of the Monaco Growth Forums (July 24-26), Dr. Ann Kwong, Founder and CEO of Trek Therapeutics, PBC (Trek) introduced attendees to a new business model in pharmaceutical drug development.

“We know European investors are keenly interested in affordable and accessible medicines. Our business model represents a unique path for drug development that addresses severe budget constraints faced by many countries, and that can be replicated in other therapeutic areas,” said Dr. Kwong. “The Monaco Growth Forums Summer Edition provided the right audience for this important information.”

Trek’s mission is to provide cost-effective, affordable, and accessible drugs to treat patients that suffer from infectious diseases, starting with hepatitis C virus (HCV) infection. As a public benefit corporation, its commercial strategy is to price their treatment regimen low enough to include the majority of patients infected with HCV who cannot afford the expensive treatments available today; this vastly expanded market, in turn, will be attractive to investors. Between 2021 and 2023, Trek plans to launch three novel drug regimens for HCV with targeted cure rates at least equivalent to those of current HCV standard of care (≥ 95%), comparable safety and  12-week treatment duration. In the longer term, Trek plans to expand into other infectious diseases with high unmet medical need.

Infection with HCV is a global epidemic, with an estimated 135 million chronically infected people worldwide. Lifesaving HCV drugs have been developed and are currently offered by industry leaders such as Gilead, Merck, and AbbVie. Unfortunately, due to their high prices (currently US$20,000–60,000 per treatment), most of the infected are not able to afford treatment; it is estimated that fewer than 30% of those chronically infected in the US and fewer than 15% of those chronically infected in other developed countries have been treated. To address this problem, Trek treatments are planned to be priced at US$10,000.

Trek’s management team and board of directors are comprised of seasoned drug-development executives from Vertex, Schering Plough/Merck, Pharmasset/Gilead, Bristol-Myers Squibb, Roche, Celgene Global Health, Idenix, and Genzyme. Since the company’s founding in 2014, the Trek team has raised US$10M in Series A funding and has in-licensed a pipeline of four HCV drugs, which form the backbone of its HCV product offering. Most of Trek’s HCV assets are second and third generation drugs that have completed late-stage clinical development. They include TD-6450 (third-generation NS5A inhibitor from Theravance); MIV-802 (second-generation nucleoside inhibitor from Medivir); Faldaprevir (second-generation NS3 protease inhibitor from Boehringer Ingelheim); VX-222 (first-generation non-nucleoside inhibitor from Vertex).

The favorable results from two Phase 2a studies conducted by Trek have helped to reduce the clinical risk in Trek’s development program. The plan is to develop three once-daily HCV combinations in quick succession, with projected launches in the US, EU, and Mexico in 2021, 2022, and 2023.

In concert with its clinical activities, Trek is launching INSPIRE HCV TREATMENT (INSurer & Pharma Initiative to CREate Affordable & Accessible HCV TREATMENT). The goal of INSPIRE HCV TREATMENT is to work directly with commercial medical insurance companies to support the US launch of TRK-1SD, an anticipated best-in-class affordable and accessible HCV treatment with a  6-week treatment duration by 2022. Discussions with major US insurance companies are ongoing.

Trek will focus its commercialization strategy on treating underserved patients with HCV infection in high- and middle-income countries including North America and Europe. For additional high-priority markets such as Mexico, Russia, the CIS, Turkey, MENA, China and Brazil, Trek has started negotiating regional distribution and commercial licensing arrangements.

About Trek TherapeuticsTrek
Therapeutics, PBC, is a privately-held, public-benefit corporation that is developing treatments for serious infections. Its mission is to profitably develop affordable and accessible medicines to treat infectious diseases and to commercialize those medicines for global populations. Trek is currently conducting Phase 2 clinical trials in patients with chronic HCV infection, using a combination of direct-acting antivirals, and is also evaluating treatments for other infectious diseases. Trek is in the process of raising a Series B financing to support the completion of its Ph2a program and to initiate its Ph2b studies and is examining the possibility of a listing on the Euronext Growth and other markets. For further information, please visit www.trektx.com. To schedule a one-on-one meeting with the Company, please email ann.kwong@trektx.com.

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 135 million people are chronically 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 Monaco Growth Forums by Andreea Porcelli Ltd.
Monaco Growth Forums (MGF) is an exclusive, invitation-only conference highlighting growth companies seeking capital and/or greater exposure. Andreea Porcelli, MGF founder, and president, has more than 20 years’ experience as an international investment banker, finding investors for small cap companies on a world scale. She and her team select, by invitation-only, companies seeking international investor exposure to present and then socialize over three days with institutional fund managers, private asset managers, high-net-worth individuals, and industry-related sponsors and foundations—all of whom are also exclusively invited to match MFG’s highly selective criteria.