Market Overview

Peptilogics Completes Successful Pre-IND Meeting With the Food and Drug Administration (FDA) for PLG0206 in Prosthetic Joint Infections (PJI)


Peptilogics, a development stage company utilizing its innovative
peptide platform to treat multidrug-resistant bacterial infections,
today announced it recently held a pre-Investigational New Drug
(pre-IND) meeting with the U.S. Food and Drug Administration (FDA) to
discuss the regulatory pathway for the development of PLG0206 for the
treatment of prosthetic joint infections (PJI). PJI is one of the most
challenging complications of joint arthroplasty and a serious,
life-threatening condition with few effective treatment options.

"We are delighted with the outcome of the pre-IND meeting," said Sanjay
Kakkar M.D., Chief Executive Officer of Peptilogics. "This key
interaction, in addition to the recent QIDP Designation, establishes a
viable development path for PLG0206 through clinical proof of concept in
this important and significant area of unmet medical need." Earlier this
year, PLG0206 was granted Qualified Infectious Disease Product (QIDP)
designation by the FDA.

The FDA meeting served to reach agreement on the details of the
development path for the use of PLG0206 in the treatment of PJI.
"Peptilogics greatly appreciates the highly positive feedback we
received in our pre-IND meeting with the FDA," said Jonathan Steckbeck,
Founder, President and Chief Scientific Officer. "Their clear guidance
confirms our plans and will greatly assist our future IND application."

Since PLG0206 will be administered locally into infected joints,
Peptilogics has developed a novel population pharmacokinetic (PK) model
to simulate systemic absorption following local administration. Parviz
Ghahramani, PhD, PharmD, MSc, MBA, early development and Clinical
Pharmacology advisor for Peptilogics, will be presenting a poster
titled, "Interspecies Allometric Scaling of pre-clinical Data to Predict
Human PK Following intravenous and Open Joint Irrigation of PLG0206 – a
Novel Antibacterial Peptide" at the upcoming Ninth American Conference
on Pharmacometrics (ACoP9). The conference will be held October 7 - 10,
2018, at the Loews Coronado Bay Resort near San Diego, CA. ACoP is the
annual scientific meeting of the International Society of
Pharmacometrics (ISoP). "We are excited to present this population PK
model, developed for PLG0206 administration," said Dr. Ghahramani. "This
model is the first to predict absorption following local administration
and will be a powerful tool in the development of PLG0206."

About PLG0206

PLG0206 was developed utilizing Peptilogics' novel eCAP (engineered
cationic antibiotic peptide) platform. This technology dramatically
amplifies the antimicrobial activity found in naturally occurring
peptides while at the same time potentially delivering an improved
systemic safety profile. In preclinical studies, PLG0206 eliminated a
variety of biofilm-associated bacteria, including methicillin-sensitive
(MSSA) and methicillin-resistant (MRSA) Staphylococcus aureus clinical
isolates, sterilizing implants following short exposure in a biofilm
model, suggesting that it could rapidly kill implant-associated biofilm
bacteria in a clinical setting.

About Peptilogics

Peptilogics is an early-stage biotechnology company developing a new
class of antibiotics with a novel mechanism of action derived from their
eCAP (engineered cationic antibiotic peptide) platform for the treatment
of multidrug-resistant infections. Through rational design, this
technology dramatically amplifies the antimicrobial activity of
naturally-occurring peptides while at the same time achieving a strong
systemic safety profile. The eCAP platform has the potential to produce
antibiotics with broad-spectrum activity with low risk of generating
resistance, due to the unique mechanism of action involving the targeted
disruption of bacterial membranes. For more information visit:

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