FIBROSIS—IMPLICATED IN 45% OF DEATHS1 IN DEVELOPED COUNTRIES
Unknown to the general public, fibrotic diseases (i.e. NASH2 and systemic sclerosis) cause pathological hyper-scarring, which may prove fatal for patients if spread to vital organs. Nearly 45% of deaths in developed countries are linked to fibrosis diseases affecting vital organs—such as the heart, liver, lungs or kidneys.
Inventiva has built a strong technology platform based on its extensive knowledge of the mechanisms of fibrosis, a chemical library of over 240,000 molecules and cell models, including patient cells, allowing the discovery of new therapeutic mechanisms for the treatment of fibrosis diseases.
THREE LATE-STAGE PROJECTS IN FIELDS COVERED BY BIG PHARMAS
Inventiva has developed Lanifibranor (IVA337), a new generation of pan-PPAR. Its unique action mechanism permits the activation of all the PPAR subtypes (alpha, gamma and delta) in order to slow, stop or even reverse fibrosis progression.
The anti-fibrotic effects of Lanifibranor may potentially treat several fibrosis-related diseases. Inventiva is initially focusing on two indications: NASH, a severe fibrotic condition of the liver affecting over 30 million people in the United States3 and with a global market estimated between $35 billion and $40 billion4 worldwide, and systemic sclerosis, an orphan disease with no approved therapy affecting nearly 170,000 patients in the world and with a global market estimated over €1 billion in the United States5. Lanifibranor’s Phase IIb headline results with respect to NASH are expected as of mid-2018 and in the second half of 2018 with respect to systemic sclerosis.
In addition, Inventiva is developing a second clinical program with Odiparcil (IVA336), a drug candidate for the treatment of three forms of mucopolysaccharidosis (MPS), rare genetic disorders affecting children. The recruitment of the first patient for the proof of concept Phase IIa study, which is already initiated, is scheduled for the beginning of the second semester of 2017 and the study results are expected in mid-2018 for the treatment of the Maroteaux-Lamy syndrome (MPS VI, a disease affecting one live birth out of every 225,000).
TWO STRATEGIC PARTNERSHIPS WITH ABBVIE AND BOEHRINGER INGELHEIM
As a testament to its expertise and recognition as a major player in the field of fibrosis, Inventiva has already entered into two separate R&D partnerships with AbbVie and Boehringer Ingelheim, two world renowned pharmaceutical companies. The project relating to fibrosis with AbbVie, in its research phase, aims at the validation of new therapeutic targets in the field of fibrosis. The partnership with AbbVie will expire in August 2017.
Inventiva may receive in the future significant payments depending on the preclinical, clinical, regulatory and commercial milestones, as well as royalties on sales of products covered by these partnerships. The agreement with Boehringer Ingelheim provides for milestone payments linked to scientific milestones which could reach up to €170 million, excluding royalties, whereas the amount of the agreement with Abbvie were not made public. Inventiva also holds an exclusive portfolio of pre-clinical projects, which may lead to new partnerships in the future.
1 The Journal of Clinical Investigation; Common and unique mechanisms regulate fibrosis in various fibroproliferative diseases; March 2007.
2 Non-Alcoholic StéatoHépatitis
3 Angulo et al. Hepatology 1999; 30(6):1356-62. ; Minervini et al. J Hepatology 2009; 50:501–510.
4 Market survey conducted by Deutsche Bank, July 14, 2014
5 Corbus Investor Presentation ; Cytori Therapeutics Investor Presentation