Applying Decades of Experience with an Eye on the Future of Small Molecule Development
For decades before antibody drugs were discovered, small molecule drugs have been used therapeutically. These small molecule drugs – one of the more well regarded being aspirin (which originates from the bark of the willow tree to produce acetylsalicylic acid are quite prevalent in a variety of traditional medicines in many cultures and for many years have been mined by pharmaceutical companies and biotech companies in order to provide therapeutics for novel diseases.
Small molecules are all chemically derived and can be chemically synthesized and are generally cheaper to produce, but it requires a really sensitive chromatographic technique in order for us to be able to develop an appropriate assay. This is what we have specialized in at Agilex since 1996, nearly three decades worth of experience in setting up these assays for sponsors.
Agilex is equipped and experienced in Small Molecule Development
Agilex has 17 Sciex triple quadrupole machines, with varying sensitivity, and this enables us to support anything from a classical small molecule, chemical entity, to a novel chemical entity, or even a repurposed drug with oligonucleotides, peptides, aptamers, and antibody drug conjugates.
What really sets us apart is the fact that we have such enormous capability to support small molecule drug discovery and regulated bio analysis. Our scientists have decades of experience in developing complex methods and we’ve seen a lot of novel molecules come through the clinic that have required incredible sensitivity at the lower end of the curve, and Agilex has been able to successfully deliver these projects.
Changes in the World of Small Molecule Development & Psychedelics
Recently there has been a lot of interest natural medicines and specifically drugs that can be derived from plants. A significant portion of this interest is in the field of psychedelics – psilocybin in particular. Psilocybin is a naturally occurring drug found in more than 200 different types of fungus mushroom species and is converted from a phosphorylated pro drug (psilocybin) to a more potent psychedelic called psilocin. Psilocin a psychoactive compound very similar to serotonin and it acts as a neurotransmitter on specific receptors in the central nervous system.
The main reason behind the interest in these sort of neuropsychiatric compounds has to do with addressing the symptoms of very notable diseases associated with Parkinson’s, post-traumatic stress disorder (PTSD), anxiety, and depression. These natural components of the “magic” mushroom have a relieving effect on a variety of these conditions.
In order for us to detect the pro-drug psilocybin and psylocin in a clinical trial environment (where sponsors are looking at being able to microdose very low concentrations of these compounds that have been synthesized chemically from their natural derivatives) Agilex has developed and validated a sensitive chromatographic LC-MS/MS assay to measure the same level of sensitivity to support clinical studies.
Setting Agilex Apart by Staying Ahead
Agilex is always pushing the boundaries of what can be done chromatographically with the mass spectrometer. We’re looking at how we can lower the level of sensitivity in order to support studies like the mushroom studies that are coming into Australia. The Australian TGA reclassified psilocybin to recognize psychedelics as medicines recently, and this has served as the catalyst to accelerate the development of these treatments in the clinic in Australia. By removing these governmental restrictions, it now opens us up to be able to develop these really sensitive methods for clinical studies.
A Track Record of Small Molecule Leadership and a History of Success for Our Small Molecule Clients
Our clients have successfully lodged their applications with the US FDA for their novel drug entities using data generated from our mass spectrometry group in order to support novel drugs that have recently been licensed.
Any small to medium biotech company that have a pipeline of novel chemical entities, peptides, oligonucleotides, and that are either ready to go into preclinical studies or are ready to go into the clinic – they should talk with Agilex about bringing that work to Australia.
These companies that will benefit from the Agilex experience. We have the preclinical toxicology facility in Brisbane and are able to support multi-species dosing across multiple dosing routes for small molecule drugs. We can support preclinical rat, dog, mouse, and mini pig studies that are required to support the safety assessments of new chemical entities in order to expedite drug discovery programs into the clinic.
We’re Ready When You Are – and Now You Can Rest, Assured
Agilex’s capacity means that we have short start of time and we are able to hit the ground running with a small molecule program, once we actually have the drug and internal standard in our hand and all of the data generated is developed and validated to the latest ICH-M10 guidance (meaning that the data is internationally recognized by all of the regulated agencies for quality and validity). In fact, even before the release of ICH-M10 guidances, we’ve always had a workflow that covered all regulatory agencies – because typically our clients come from all over the world to Australia to utilize Agilex for their drug discovery programs, so we’ve always had a workflow that’s covered, the EMA and the FDA and to be able to support those clients through their, their last cycle.
To learn more about conducting your drug development program in Australia or about Agilex Biolabs, contact our experts today.
