The pharmaceutical industry: a sector facing issues in innovation
In the last decade, the pharmaceutical sector has been facing structural issues when it comes to bringing new pharmaceuticals to the patient. Indeed, studies have revealed that the average cost to develop a single drug has tripled to greater than €1.7Bn in real terms since 2003 while numerous patent expirations have reduced revenues from blockbuster drugs. Also, the average forecast for peak sales has declined by 43% due to increasing development of specialized drugs for smaller patient populations. Lastly, the attrition in the drug development pipeline remains high notably for lack of efficacy. On average, 24 failed drug development programs occur for every one molecule entering to market.
In a word, the process of developing a new drug is very time consuming, extremely costly and highly risky, with minimum chance of a successful outcome.
In addition, the rate of innovation in pharmaceutical development is low, which results from a focus on a restricted number of drug target classes considered more tractable. One answer to that was to develop “me-too” drugs, which are clinically equivalent therapeutics to replace pioneering drugs as opposed to focusing on new targets.
Still, there are a large number of diseases with unmet medical needs because of a lack of innovation and new cellular targets investigated by the pharmaceutical industry. In the last decade, there has been growing awareness of the limited structural diversity in pharmaceutical company compound collections but there are still room for new approaches and new therapeutic strategies.
ENYO Pharma: Bringing new opportunities to the Pharmaceutical Industry
Having made that analysis, Two veterans of the pharma industry and four scientists of the Infectiology Research Center in Lyon, France created ENYO Pharma in January 2014.
ENYO Pharma is on the mission to create a change by developing new therapies against diseases with unmet medical needs thanks to a wholly new approach. ENYO Pharma’s team has developed a unique and innovative drug discovery engine inspired by viruses to identify and develop first-in-class drug candidates in multiple attractive diseases.
The company is currently developing its first leading product EYP001 in two liver diseases: chronic hepatitis B and NASH (Non-alcoholic steatohepatitis). However many other therapeutic areas such as oncology or metabolic disorders are also being investigated through ongoing development programs.
Dr. Jacky Vonderscher, the Erudite behind ENYO Pharma
ENYO Pharma’s team is world class with a crucial mix of pharma senior leadership and scientific excellence notably in virology which drives the company forward. But a team can only coordinate thoughtfully and march forward towards excellence when they get a good leader. And ENYO has a genius as its leader, the co-founder and Chief Executive Officer of the company, Dr. Jacky Vonderscher, a pharma veteran and an experienced drug hunter. He saw the potential to rapidly translate the expertise in virus-host interactions of ENYO Pharma’s scientists into novel drug candidates in many attractive conditions beyond infectious diseases.
Dr. Vonderscher held multiple Senior Executive roles notably in R&D. Previously he was operating as a Senior VP Head of Translation Research Sciences and as a Senior VP Head of Molecular Medicine Labs at Roche in USA and Switzerland (2008-2012). He also held other senior positions with Novartis in the USA and Switzerland (1979 to 2008). He is well known for his leading role in the discovery and development of Sandimmum Neoral® in the 90s and was also involved as co-inventor of two other important drug products, the blockbuster Everolimus (Certican® and Afinitor® Products) and Mycophenolic Acid Sodium salt (Myfortic® Product) He’s a Board member of Inatherys, ObsEva, and Step Pharma as well as a SAB member of Inotrem. He recently was also coopted as a board member of EBE (European Biopharmaceutical Entreprises, a European Trade Association). As well as a SAB member of Inotrem.
Drug Discovery Inspired by Viruses
Over millions of years of evolution, viruses have perfected their ability to modulate and hijack the cell functions for their own benefit.
ENYO Pharma’s team is convinced that by imitating viruses it is possible to modulate cellular functions and proteins without endangering the cell to open new perspectives for developing medicines.
ENYO Pharma’s team is thus developing drug discovery programs on many intracellular host targets yet untapped by pharmaceutical industries because considered as non-tractable until now. This would lead to the development of first in class therapeutics.
The approach allows finding new cellular targets which are not exploited yet to diversify the current therapeutic pipeline and increase the chance of getting a cure for diseases with still unmet medical needs.
This approach matches the needs of the large Pharma to replenish their pipelines with innovative drugs through in licensing, maintains the primacy of public health interest and maximizes individual medical benefit.
ENYO Pharma’s expertise and knowledge have also raised the interest of major investors, who invested €22M in the company in early 2016 to continue the work on Hepatitis B and other programs. The company is currently discussing with various US and European investors to raise its Series B to fund its two Phase II in chronic hepatitis B and NASH and bring at least one new compound in clinic.
Other programs (EYP002, MIMESIS): ENYO Pharma further validation of ENYO’s approach
ENYO Pharma already made the proof-of-concept of its drug discovery engine with its first candidate EYP001 being tested in patients. It second leading molecule, EYP002 was inspired by a strategy employed by Influenza to regulate host cell biology and allowed to find a unique novel target focused on mitochondria and stress responses that could also be relevant for oncology and metabolic diseases.
Following that, ENYO has received funding from the European Union’s Horizon 2020 research and innovation program for the MIMESIS project that results from the scale-up of ENYO Pharma’s innovative drug discovery engine and aims at screening 10,000 molecules. This library of developable chemical templates is currently screened in phenotypic assays against 4 viruses (Flu, RSV and HRV (to respiratory viruses) and Zika), a mycobacterium (TB) and as inducers of Immunogenic Cell Death in tumors. With €3.6 million spending over 24 months, most promising chemistries will be the starting point for numerous hit to lead optimization programs funded within the EU grant.
The initial results showed a high number of leads and as a single organization ENYO Pharma will not be able to develop them all and will likely partnerships to licence or co-develop some of those molecules that are not part of an internal specific program.
“Thanks to the MIMESIS approach, ENYO Pharma will multiply the opportunities to bring very innovative drugs working on untapped human targets which will translate into higher pharmaceutical benefit to patients. This approach has not been used before in the pharmaceutical industry and is potentially transferable to any human disease. Within less than a year we have already gained 50 hit molecules on undrugged targets and they are being validated as we speak” asserts Dr Vonderscher.
Feather of Achievement in ENYO Pharma’s Cap
ENYO Pharma is developing its leading drug candidate in both chronic Hepatitis B and NASH.
NASH is the most common liver disorder in Western countries. Its main consequence is liver fibrosis, cirrhosis, and hepato cellular carcinoma. Currently no treatment exists for this disease which represents an important challenge.
Hepatitis B remains a major worldwide public health problem with over 260 millions of chronically-infected people despite extensive vaccination programs. Chronic hepatitis B evolves towards life threatening complications including liver cirrhosis and cancer. Current therapeutic regimen, often fail to cure HBV and are lifelong treatments.
Recently, ENYO Pharma has successfully completed EYP001 first in man Phase 1 study. The Phase 1a single and multiple ascending dose trial evaluating EYP001 in healthy subjects have been completed. The results show that EYP001 was safe and well-tolerated at all doses studied in 80 subjects. The drug is now starting a phase 1b clinical trial in patients with chronic HBV with results due in early 2018 with two phase 2 trials in HBV and NASH planned for mid 2018.