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 aureus, (MRSA).

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 Therapeutics.

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 resistant bacteria.

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