Enyo Pharma raised €40 million ($46.9 million) to fund the launch of its first two phase 2 clinical trials of its lead candidate, EYP001, in chronic hepatitis B and nonalcoholic steatohepatitis, by the end of the year.
The relatively large series B round for the Lyon, France-based company, which included U.S. and European investors, was led by OrbiMed. Andera Partners and Bpifrance Large Venture joined as new shareholders, while returning investors included Sofinnova Private Capital VII, Morningside Venture Investments, InnoBio and Inserm Transfert Initiative.
Oral EYP001, a synthetic nonsteroidal, nonbile acid FXR agonist—currently being studied in a phase 1b trial in HBV—aims to target the body’s latent cccDNA virus reservoirs instead of managing the replication of HBV itself. When given in combination with standard-of-care antivirals, Enyo hopes EYP001 will cure hep B after six months of therapy.
The company also plans to advance a second asset, EYP002, with IND-enabling studies starting before 2019. Initially developed as a phenotypic assay to block influenza replication, EYP002 modulates a small family of proteins known to regulate mitochondrial metabolism and stress responses. It has possible applications in metabolic diseases, oncology and rare genetic disease being observed in animal pharmacology studies with assistance from Charles River Laboratories.
Iain Dukes, a venture partner at OrbiMed, will join Enyo’s board of directors, with additional representatives from Andera, Bpifrance and OrbiMed joining as observers. The funding follows a 2016 series A round, led by Sofinnova, that brought in $24 million to kick-start human testing of EYP001.
Citing WHO statistics, the company said over 350 million people infected with hepatitis B currently await treatment, with half of them in Asia. Meanwhile, NASH ranks as the most common liver disorder in Western countries, including more than 5% of the population, resulting in liver fat accumulation, inflammation and hepatocyte injury. If left untreated, it can cause tissue scarring, liver failure or cancer.
The potentially lucrative NASH market has seen several companies race to the clinic, including Gilead, Bristol-Myers Squibb, Allergan, Shire, Genfit and Intercept, with some predicting it to overtake alcoholism and hepatitis as the leading cause of liver transplants in the next 10 years. In mouse models, EYP001 demonstrated efficacy in decreasing NASH-related fibrosis, steatosis, inflammation, ballooning and triglycerides.
The eventual commercialization of NASH-targeting medicines could still be tricky, however, with diagnoses largely performed through invasive liver biopsies. In addition, the disease is primarily asymptomatic in early stages, when excess liver fat can also be reduced through diet and exercise.
Editor's note: This story was updated to correct and clarify the combination therapies Enyo hopes to pursue in hepatitis B.