Acurx Pharmaceuticals
Mechanism of Action
DNA polymerase IIIC (pol IIIC) has been shown to be essential for replicative DNA synthesis in aerobic, low G-C Gram-positive bacteria, i.e. those with a
low guanine-cytosine  (G-C) ratio relative to their adenine-thymine (A-T) ratio. Pol IIIC-specific genes of several such Gram-positive bacteria have been
cloned and expressed, and these enzymes share a unique capacity to be inhibited by 6-anilinouracils (AU), 2-phenylguanines (PG) and related
compounds which are analogs of 2'-deoxyguanosine 5'-triphosphate (dGTP).  ACX-362E is a recent example of this class of compounds and is being
advanced to clinical trials.

ACX-362E has been demonstrated to inhibit purified
C. difficile pol IIIC with a Ki of 0.325 µM, confirming the ternary complex hypothesis.  In addition,
a whole cell study involving the measurement of chromosomal DNA replication demonstrated the expected gene dosage results that suggest inhibition
of DNA replication by ACX-362E.

Clinical Development Plan
Acurx plans to file the IND and initiate Phase 1 clinical trials in 4Q2018
FDA has granted QUALIFIED INFECTIOUS DISEASE PRODUCT (QIDP) status under the GAIN Act
(section 505E(g) of the FFDCA) for ACX-362 because it is “an antibacterial… drug for human use intended to
treat serious or life-threatening infections, including those caused by… an antibacterial or antifungal resistant
pathogen…”.  

C. difficile is a pathogen listed in the GAIN Act as a pathogen that causes serious or life-threatening infections.

ACX-362E is active against the GAIN Pathogen
Clostridium difficile