OUR PIPELINE
Sepsis
Sepsis may be the largest medical unmet need for which there are no approved products. Sepsis affects nearly 49 million people worldwide each year, killing an estimated 8 million, and is the most common killer of children, taking more than 3.4 million each year. In the US, Sepsis affects 1.7 million patients annually resulting in 270,000 deaths. 1 in 3 patients who die in US hospitals have sepsis. COVID-19 only made the situation worse.
Up to 50% of sepsis survivors are left with long-term physical and/or psychological effects.
Sepsis is the #1 cost of hospitalization in the U.S. Costs for acute sepsis hospitalization and skilled nursing are estimated to be $62 billion annually.
The average cost per hospital stay for sepsis is double the average cost per stay across all other conditions.
Sepsis is the #1 cause for hospital readmissions to the hospital, costing more than $3.5 billion each year.
19% (19 out of 100) of people hospitalized with sepsis are readmitted within 30 days.
Fe Pharmaceuticals has 6 scientific publications describing DIBI proof-of-concept animal studies in sterile and fulminant sepsis, demonstrating potent anti-infective and anti-inflammatory properties (Dickson, et al 2018, Fokam, et al 2020, Fokam, et al 2020a, Islam, et al, 2016, Lehmann, et al 2021, Thorburn, et al 2017)
Results include significantly enhanced survival of sepsis after DIBI treatment alone or combined with Imipenem (IMI), an antibiotic, in an animal model with 100% mortality in the untreated control arm.
There is strong government recognition of the unmet need in sepsis with financial support for clinical programs from BARDA (Solving Sepsis) and others.
At least 3 clinical programs for AMRI and/or sepsis received at least $70 million in pledged support from BARDA in 2020-2021.
Fe Pharmaceuticals has established a relationship with NIAID in which they are supporting some of the DIBI pre-clinical development work.
Because DIBI is nontoxic and synergistic with antibiotics, it can be used early in sepsis as a first administered agent, rather than as a last option when patients are already in septic shock.
Decades of bad experiences in sepsis product and company failures make investors wary but the use case for DIBI as a first option therapy has a much better chance of success because it will arrest the patients’ infection and decline rather than trying to reverse septic shock, a much more difficult problem. When every second counts, something that can be administered to patients without having to diagnose the infecting organism or what drugs it is sensitive to will save hours and lives.