Phico Therapeutics reaches first human clinical trials with novel
MRSA-beating antibacterial technology
23 September 2009
Phico Therapeutics has reached an important next stage of development
with its novel antibiotic entering its Phase I clinical trial. The new
technology is based on the antibiotic protein SASP which is delivered
into the target bacterial cells by bacteriophages.
Pre-clinical data has shown that its antibiotic, SASPject PT1.2, is
rapidly effective against methicillin-resistant Staphylococcus
SASP, the active ingredient of SASPject PT1.2 showed a rapid
bacterial killing action against S. aureus (MRSA) causing a
5-log drop in viable cells within one hour for the PT1.2 treated 10^7
cfu/ml cultures, despite the different growth conditions tested and the
presence of mucin (a glycoprotein that is a part of mammalian mucus).
PT1.2 is first in the new class of antibiotics forming Phico
Therapeutics’ novel antibiotic platform technology called SASPject.
Antibacterial proteins, SASP, comprise the active ingredient of SASPject
act by binding to bacterial DNA and haltreplication and gene expression,
resulting in rapid bacterial cell death. SASPject PT1.2 is now in Phase
I clinical trials.
“The completely new SASPject technology has the capability to
revolutionise antibiotic therapy and human trials are a crucial
milestone in product development explains Dr Heather Fairhead CEO, Phico
Phico Therapeutics’ PT1.2 001 trial is a Phase I, randomised,
double-blind, placebo controlled, sequential single to multiple dose
escalation study, with a planned enrolment of 46 subjects. The study aim
is to assess the safety and tolerability of 2 different doses of PT1.2
in healthy subjects.
The primary objective of development of PT1.2 is to demonstrate that
SASPject PT1.2 is effective for elimination of nasal carriage of S.
aureus, including MRSA. The initial target indication for
registration is the eradication of nasal colonisation of methicillin-resistant
S. aureus (MRSA) in adult patients and healthcare workers as a
part of a comprehensive infection control programme to reduce the risk
of infection among patients at high risk of methicillin-resistant S.
aureus during institutional outbreaks.
SASPject technology explained
SASPject is a novel antibiotic therapy that can be targeted to any
bacteria including multi-drug resistant bugs. The first SASPject, PT1.2
has been developed initially for nasal decolonisation of S. aureus
including MRSA. SASPject has two components, the first is antibiotic
protein SASP which inactivates bacterial DNA, and the second is a
target-specific delivery vector.
In SASPject, the gene for the antibiotic protein SASP is delivered
through the target bacterial cell wall by a bacteriophage (a virus that
attacks only bacteria). SASP is produced inside the targeted bacterium
where it binds to and inactivates the bacterial chromosome and plasmid
DNA. In this way SASP prevents toxin production and cell reproduction
thus halting the spread of the infection, and also stops bacterial
metabolism, which kills the targeted bacteria. Crucially, SASP binds to
the bacterial DNA in a non-sequence-specific manner and so does not
allow the bacteria to evolve resistance.
SASPject is effective against S. aureus, a Gram positive bacterium
and E. coli, a Gram negative bacterium. These findings mean that
SASPject has the potential to be effective against all species of drug
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