Worldwide the prevalence of NAFLD is ca. 25%, and the economic burden due to NAFLD is predicted to affect Europe and US with over €35 Bn and $103 Bn per year in direct cost, respectively. It is estimated that the market size of NASH in the 7MM (USA, Germany, France, Italy, Spain, UK and Japan) will reach up to €42.5 Bn in 2027, with a CAGR of 23% for the period 2016-2027.
Despite the prevalence of fibrotic diseases and the huge impact it has on human health, there are no effective drugs available. Thus, there is a great market potential for new anti-fibrotic agents that can reverse disease and increase survival rates. “Big Pharma” has identified this segment as prioritized and is searching for new drug candidates to meet the need.
The final goal is to develop a first in class drug candidate against, primarily liver, fibrosis. In line with this, collaborative research between Dan Holmberg and Leifeng Cheng has identified the small molecule FX1004. In preliminary PoC studies, we have demonstrated that FX1004 can efficiently inhibit and reverse liver inflammation and fibrosis in a pre-clinical in vivo model.
- There is an urgent need for drugs for fibrotic conditions, such as liver fibrosis, which the market analyses clearly show. The development of an efficient anti-fibrotic small drug substance has the potential to fill this unmet need.
- Given that the vast majority of all large pharma companies have programs in this diagnosis area, potential customers for licensing or sales are likely to be among these stakeholders.
- The broader societal benefits include increased survival rates and improved quality of life of a great pool of patients that are affected by debilitating fibrotic diseases.
No drugs are on the market that can efficiently treat fibrotic conditions. Based on information from GlobalData (May 2019) we have found that 21 of the 25 top pharmaceutical companies, e.g., Gilead Sciences, Merck and Novartis, have drug development projects underway in the fibrosis segment. Thus, the competition is fierce in this field. However, because the very same companies that constitute the competition also represent potential buyers of licenses of our substance this also represents an opportunity.