ENYO Pharma raises €40m to pursue phase II clinical development of HBV and NASH drug

This new funding will enable the company to finance the two first Phase II clinical trial of its EYP001 asset in both chronic hepatitis B (HBV) and NASH. A second asset is also planned to enter clinic by 2019.

The deal was led by OrbiMed, followed by Andera Partners (previously EDRIP) and Bpifrance Large Venture as new shareholders.

Existing shareholders, Sofinnova Private Capital VII, Morningside Venture Investments, InnoBio and Inserm Transfert Initiative also participated to this round. This represents another landmark achievement after the €22 million Series A fundraising closed in 2016.

Dr Iain Dukes, a Venture Partner with OrbiMed, will now join the Board of Directors and commented “We are excited to lead the current round of investors in ENYO Pharma and look forward to advancing EYP001 into larger HBV and NASH patients studies.”

Other representatives from Andera Partners, Bpifrance Large Venture and OrbiMed will be observers to the Board of Directors, with Raphaël Wisniewski, Laurent Higueret and Carl Gordon, respectively.

Annette Clancy, Chair of the Board of Directors, commented that “this influx of new capital and investors will significantly strengthen the expertise of the Board as we guide the company though its ambitious development plans over the next 12 -18 months.”

Jacky Vonderscher, CEO, commented “we are delighted to have successfully raised sufficient new capital from such quality investors who will enable us to grow and demonstrate the full potential of the Company.”

ENYO Pharma lead candidate, EYP001, is an orally bioavailable small molecule currently being evaluated in phase Ib in patients with chronic hepatitis B. EYP001 is a synthetic non-steroidal, non-bile acid FXR agonist with a very good tolerability profile.

Two phase II clinical trials are planned to start before end of 2018 in chronically HBV infected patients and in NASH patients.

Hepatitis B remains a major worldwide public health problem. According to the WHO, over 350 million people chronically infected with the hepatitis B virus are awaiting treatment, half of them in Asia.

Despite progress with vaccine coverage, close to 300 million people will remain chronically infected in the 2030s, putting them at major risk of developing cirrhosis and liver cancer. Contrary to lifelong standards of care that target essentially virus replication, EYP001 is targeting the cccDNA (‘virus reservoir’) therefore aiming for an HBV real cure.

NASH (non-alcoholic steatohepatitis) is the most common liver disorder in Western countries and results in liver fat accumulation leading to inflammation and hepatocyte injury. It is estimated that more than 5% of the population has an advanced form of NASH. Most key opinion leaders agree that FXR agonists could be the backbone of future NASH therapies.

EYP001 has demonstrated efficacy in the Stelic mouse model (STAM^TM) with significant decrease on almost all pathological parameters of NASH (fibrosis, steatosis, inflammation, ballooning, triglycerides and NAS). It appears to differentiate from other FXR agonists by a better C4/FGF19 balance with a more prolonged C4 decrease and a lower peak of FGF19.

ENYO Pharma’s second asset, EYP002, is a new first-in-class chemical series which should enter IND enabling studies in H2 2018. Initially developed using inhibition of influenza replication as a phenotypic assay, molecules modulate a small family of proteins known to regulate mitochondrial metabolism and stress responses.

The scope for therapeutic application extends largely beyond infectious diseases with several other indications having already been positively tested through in vitro and in vivo animal pharmacology studies (e.g. Metabolic Diseases, Oncology, and even a genetic rare disease).

Source: Company Press Release