Company: RVRC
Filing Date: 2025-12-12
Form Type: S-1/A
Source: 0001213900-25-121070
Chunk: 122

Company: Revium Rx.
Filing Date: 2025-12-12
Form: S-1/A
Chunk 122
---
 program remains in preclinical development, and there
can be no assurance that such characteristics will be observed in humans or that they will result in regulatory approval.

Among our direct competitors are companies advancing
new chemical entities (NCEs) that exhibit novel mechanisms of action against resistant bacteria, including Spero Therapeutics and Entasis
Therapeutics, which are developing innovative classes of antibiotics designed to target gram-negative bacteria, including those resistant
to carbapenems and third-generation cephalosporins. These new antibiotics aim to address critical gaps in current treatment options for
multidrug-resistant infections. The US-based startup Acurx Pharmaceuticals offers Ibezapolstat, their lead antibiotic candidate, for
the treatment of clostridium difficile infections. This antibiotic blocks the Pol 3IIIC enzymes in streptococcal, staphylococcal, and
enterococcal infections. The antibiotic also inhibits further DNA replication of CDI-causing pathogen and is currently undergoing Phase
II trials. Dutch startup AGILeBiotics creates novel antibiotics for the treatment of hospital-acquired infections such as ventilator
acquired pneumonia, bloodstream infections, and neonatal sepsis. Further, this startup develops treatment options for multi-drug resistant
tuberculosis and cystic fibrosis. Their Toframicin agent is currently undergoing preclinical development and is already delivering in-vitro
results. The US-based startup Geom Therapeutics, in partnership with a Korean biotechnology company LegoChem Biosciences, provides GT-1,
a novel cephalosporin class antibiotic. GT-1, with the help of a siderophore receptor, binds with iron and takes a trojan horse approach
to attack the resistant bacteria. The Global Antibiotic Research & Development Partnership (GARDP) in collaboration with Innoviva
Specialty Therapeutics, a subsidiary of Innoviva, Inc. (Nasdaq: INVA), recently announced that zoliflodacin, a clinically competitive
candidate antibiotic, met its primary endpoint in an global pivotal phase 3 clinical trial (for the treatment of gonorrhoea indication).
Study investigators found that oral zoliflodacin demonstrated statistical non-inferiority of microbiological cure at the urogenital site
when compared to treatment with intramuscular (IM) injection of ceftriaxone and oral azithromycin, a current global standard of care
regimen. In the study, z