Development of a detection assay and validation method for a small molecule antimicrobial unstable in biological samples

Neem Biotech Ltd

National Measurement Laboratory at LGC
Round 3

Neem Biotech Ltd is responding to the current antimicrobial resistance crisis through the development of first-in-class synthetic biofilm disruptive molecules to be used as adjunctive agents in the treatment of infectious diseases.

Neem has extensive experience in producing garlic-derived compounds known for their antimicrobial activities.

Our leading expertise in organosulphur chemistry has allowed us to identify a number of synthetic analogues displaying high intrinsic antimicrobial activities _in vitro_ and _ex_ _vivo_ human models.

However, despite our best efforts _in-house_ and in outsourced CRO endeavours, we have as yet not been able to overcome our inability to detect our leading compound which is unstable in biological matrices.

This problem has effectively not only implied significant cost with no return but prevents us from taking this molecule further into development and to perform the required regulatory preclinical toxicology studies.

In collaboration with LGC, we envision the development of an analytical method for the detection of our compound in the whole blood, serum and plasma of accepted toxicology species.

The key objectives are to determine whether the compound is binding to
1. assay vessels, or
2. matrix components (proteins), and,
3. determine whether the parent molecule is breaking down into metabolites. The ability to access GC-MS and quad-core MS technology in conjunction is not available to Neem Biotech, neither _in-house_, nor is it commercially available/feasible (GC-MS).

The innovation lies in the _de novo_ development of an analytical method validated in three toxicology-relevant mammalian species for an, as yet, un-analysable antimicrobial molecule.

The validated method will undergo tech-transfer to a UK-based CRO that will subsequently implement this analytical method for our development/preclinical studies.

Importantly, this method development will be invaluable to similar studies and development objectives related to all other Neem organosulphur compound assets.

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