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

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For many years it has been recognised that there are bacterial infections that persist and are refractory to treatment with antiseptics and antibiotics. Antibiotic resistance is currently one of the highest threats to human health, given the increasing number of pathogens that develop resistance to known antibiotics as well as the inability, thus far, to discover new ones to offset acquired resistance. Neem Biotech is thus responding to the this world health crisis through the development of first-in-class synthetic anti-microbial molecules to be used as adjunctive agents in potentiating antibiotic efficacy. Neem Biotech 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 compounds with high antimicrobial activities and that synergise with antibiotics and antiseptics in microbial cells killing. This results in the more rapid and efficacious resolution of infection, reducing its spread and dissemination to other anatomical locations.Having now progressed our selected drug candidate into preclinical development, we have encountered an analytical challenge, namely, the inability to detect and quantify our molecule in biological samples such as blood and plasma. This poses extraordinary barriers in taking this promising compound further into the clinic since we are unable to undertake the required regulatory pharmacological, phamacokinetic and toxicology safety studies.Neem has made several attempts to resolve this analytical problem in-house using LC-MS and has outsourced two CRO's to develop and validate detection methods for our compound, both of which were unsuccessful and costly.LGC is the designated institute for Chemical and Bio-Analytical measurement in the UK, working across several sectors. Led by Chris Hopley, an expert in analytical chemistry and Principal Scientist Mass Spectrometry, the group at LGC has a number of instrument platforms and technologies to develop methods for novel target compounds in biological matrices. Importantly, once developed, this method can be easily transferred to a commercial service towards the successful preclinical studies of our selected and all future organosulphur compound assets developed at Neem Biotech.