Clinical and Regulatory Development of Antibiofilm Drugs: The Need, the Potential, and the Challenges - Antibiofilm Agents: From Diagnosis to Treatment and Prevention - page 469

Table 1 Antibiofilm drugs in clinical development a
Company Antibiofilm evidence a Drug Type of molecule Clinical stage Therapeutic indication

C3 Jian
http://www.c3-jian.
com

C16G2 STAMP—specifically

targeted antimicrobial
peptide directed at
S. mutans

Phase 1 completed 8/2013 Company website
description with links
to publications

Prescription mouth rinse
for dental caries

Catholic University
of the Sacred
Heart, Italy b,c
http://www.unicatt.it

N -acetyl-cysteine
(NAC)

N -acetyl-cysteine Post-Phase 1 efficacy

study b

H. pylori clinical trial
protocol with biofilm
endpoint and peer-
reviewed publications

Helicobacter pylori
infections

ClinicalTrials.gov Identi-
fier: NCT00985608

Insmed (licensed
from Transave)
http://www.insmed.
com

Arikace Aminoglycoside anti-

biotic delivered with
eFLOW electronic
nebulizer using pro-
prietary liposomal
technology

Phase 3 P. aeruginosa in
cystic fibrosis
(CF) patients: Euro-
pean and Canadian
results announced
7/2013

Multiple peer-reviewed
publications when
drug was being devel-
oped by Transave,
however no mention
of antibiofilm activity
on Insmed website or
press releases

Lung infections:
P. aeruginosa (CF and
non-CF) and NTM

liposomal amikacin
for inhalation

Phase 2 completed in
non-CF P. aeruginosa
Phase 2 in Non-tubercular
mycobacteria (NTM)
lung infections enroll-
ing in USA and
Canada
FDA granted QIDP and
Fast Track designa-
tion for NTM

(continued)