In molecular biology and pharmacology, small molecules are noted for their ability to quickly modulate their actions. This is because for the most part, they are highly soluble. slow and moderate to first pass metabolism and the beauty of small molecules is that they can be taken orally as a drug, but also – given their size – they’re able to traverse the blood brain barrier.
For decades, small molecules have been noted for their ability to modulate neuropsychiatric disorders. There has been a huge increase over the last few years in natural medications and natural products that can be used for anxiety and stress disorders, as well as being able to relieve pain.
What makes Agilex perfectly suited for the testing of Medical Cannabis studies?
Agilex has supported numerous clients within the “natural medications” space who are investigating synthesized products of naturally occurring substances for neuropsychiatric indications in a clinical trial environment. Over the past couple of years, medical marijuana or medical cannabis has come to the forefront in treating a variety of symptoms or conditions – including post-traumatic stress disorder, epilepsy, Alzheimer’s disease, Amyotrophic lateral sclerosis (ALS), or Parkinson’s for example.
At Agilex Biolabs, we have validated a pharmacokinetic (PK) assay for the detection of five cannabinoids in human plasma by LC-MS/MS. This multiplex assay, validated to meet the FDA/EMA bioanalytical guidances for GLP studies or GCLP clinical trials essentially allows us to quantify THC (Δ9- tetrahydrocannabinol), CBD, (cannabidiol), CBN (cannabinol), and also the two major metabolites of THC; OH-THC (11-hydroxy-Δ9-THC), and COOH-THC (11-Nor-9-carboxy- Δ9-THC).
The Agilex method extracts THC, CBD, CBN, OHTHC, COOHTHC and their respective deuterated internal standards (IS) from human plasma using a sensitive protein precipitation followed by solid phase extraction LC-MS/MS procedure to allow chromatographic separation and quantification in clinical samples to enable us to rapidly start up medicinal cannabis clinical trials within Australia.
What makes Agilex stand out with small molecule services for cannabis studies?
Many cannabis studies include up to a hundred different species of cannabinoids with differing chemical structures as there are multiple species of marijuana plants.
THC (which is a psychoactive component) and the CBD (which is a more calming component of these extracts) are the main examples that are generally of interest, but because there are dozens of others, what sets Agilex apart is our ability to set up chromatography in order to extract and elucidate any additional analytes or metabolites of interest.
There is opportunity at Agilex for customers looking to Cannabis Studies soon!
Because Agilex has this fully-validated assay, we are ready to go with minimal startup time required to do a medicinal cannabis study (on the proviso that we are using the assay that we currently have validated).This is a rapid start of time to be able to support a clinical trial and that has not only speed advantages, but also cost advantages because, the assay already is fully validated. We are just rolling out analysis of samples using this fully validated assay.
Why take your cannabis studies to Australia right now?
Right now, Australia has the advantage in terms if a rapid startup. Here, we have the tax incentive for companies earning less than $20 million that could tap into that 43.5% rebate.
Additionally, whereas in some other mainstream countries where medicinal cannabis is readily available through various regulated, non-regulated shops and entities, it’s more difficult to find a drug-naive population that hasn’t already had medicinal cannabis or has had to wait for an extended wash out period. Australia is essentially a near-fully naive population when it comes to exposure to cannabis and cannabis products. Medicinal cannabis is quite highly regulated within Australia still, and in terms of the clinical trials set setting, we supported numerous clinical trials within, within the space.
This makes Australia a very attractive proposition for a medicinal cannabis program.
Agilex is Poised, Ready, and Set with Small Molecule Experience
Agilex has been a small molecule regulated biomedical laboratory since 1996 with extensive experience across all novel chemical entity drugs, oligonucleotides, drugs, and so on. Our expertise ranks us number one in Australia in terms of setting up complex chromatographic LC-MS/MS assays to support these pharmacokinetic studies coming into Australia.
To learn more about conducting your drug development program in Australia or about Agilex Biolabs, contact our experts today.
