Iron biology
Antimicrobial resistant infections (AMRI)
Antimicrobial resistant infections have often been called the slow-moving pandemic. By 2050 antibiotic-resistant infections may kill more people than cancer as we find ourselves effectively back to a pre-antibiotic era with existing classes of antibiotics no longer effective. To slow the development of antibiotic resistance, new antibiotics are often reserved for last line use, crippling their initial sales and leading to several high-profile bankruptcies and fiscal crises at companies developing them (Acheogen, Aradigm, Milenta).
Key features of DIBI
1
DIBI works against all AMRI, bacterial and fungal,
2
Resistance to DIBI cannot emerge
(no path to develop resistance to needing iron),
3
DIBI synergizes with other anti-infectives and reduces resistance to other agents,
4
DIBI is
nontoxic
These features describe an ideal first-line agent
Key features of DIBI
1
DIBI works against all AMRI, bacterial and fungal,
2
Resistance to DIBI cannot emerge
(no path to develop resistance to needing iron),
3
DIBI synergizes with other anti-infectives and reduces resistance to other agents,
4
DIBI is
nontoxic
These features describe an ideal first-line agent
Published DIBI POC studies in vitro and in vivo demonstrated effectiveness against drug resistant organisms and synergy with other antibacterial and antifungal agents. This includes demonstrating DIBI activity against pathogens like drug resistant Acinetobacter baumannii and Staphylococcus aureus including MRSA, methicillin resistant Staph. aureus, in animal models (Allan et al 2020, Harris et al 2019, Parquet et al 2018, Parquet et al 2019)
DIBI MICs against WHO Priority pathogens
The CDC reports ~2.8 million cases/yr in the US of antibiotic- or anti-fungal-resistant infections in hospitalized patients (Gram-positive, Gram-negative, fungi) and there are an estimated 750,000 deaths worldwide from antimicrobial resistant infections. This is expected to rise sharply in the coming decades.
Fe Pharmaceuticals has established a relationship with NIAID in which they are participating in some of the DIBI pre-clinical development work.
DIBI will be eligible for the benefits of the QIDP (Qualified Infectious Disease Product) program for pathogens like Acinetobacter and Staph. aureus for which we have already published proof-of-concept in animal models.
QIDP includes fast track designation, priority review designation, and 5 years of additional market exclusivity.
Prior anti-infective company failures due to poor initial sales as physicians resist writing prescriptions for fear of promoting the emergence of resistance, have led to investor skepticism of new agents. However, because resistance cannot emerge to DIBI, it is nontoxic to patients, and is synergistic with other antimicrobial agents, it does not have to be reserved for last line use and instead potentially makes an excellent first-line agent.