Overview

Pipeline

Program

Target Pathogen

Phase

Ibezapolstat 1

Clostridium difficile

Discovery Preclinical Phase 1 Phase 2
Discovery Phase complete
Preclinical Phase complete
Phase 1 Phase complete
Phase 2 Phase in progress

ACX-375C 2

Gram Positive Infections

Discovery Preclinical Phase 1 Phase 2
Discovery Phase complete
Preclinical Phase in progress
Phase 1 Phase not started
Phase 2 Phase not started

CCP 3

Multiple product candidates for Gram-positive infections

Discovery Preclinical Phase 1 Phase 2
Discovery Phase in progress
Preclinical Phase not started
Phase 1 Phase not started
Phase 2 Phase not started
  1. Ibezapolstat has been granted QIDP (Qualified Infectious Disease Product) status; FDA Fast Track designation granted.
  2. ACX375C is QIDP and FDA Fast-Track eligible and is planned to be applied for pre-IND and post-IND, respectively.
  3. Computational Chemistry Project to expand universe of potential DCBG-like Pol IIIC inhibitors in scientific collaboration with WuXi Apptec.

Addressing Difficult to Treat Bacterial Infections

Acurx's approach is to develop antibiotic candidates that block an entirely new molecular target previously unexploited in medical research, DNA polymerase IIIC (Pol IIIC).  Our R&D pipeline includes clinical stage and early stage antibiotic candidates that target Gram-positive bacteria for oral and/or parenteral treatment of infections caused by Clostridium difficile, Enterococcus (including vancomycin-resistant strains of VRE), Staphylococcus (including methicillin-resistant strains of MRSA), and Streptococcus (including antibiotic-resistant strains).  Both of these antibiotic product candidates have demonstrated the ability to effectively block the DNA polymerase IIIC enzyme in early stage studies.

The CDC (Centers for Disease Control & Prevention) has designated C. difficile as a qualifying pathogen under the GAIN Act as an urgent threat highlighting the need for new antibiotics1 See “Qualified Infectious Disease Product (QIDP) Status by the FDA.” Further, the CDC has designated vancomycin-resistant enterococci as a serious threat level priority for new antibiotic development where, despite current treatment, a significant incidence remains and significant number of deaths occur annually.