Prexton presses on into phase II testing of Foliglurax.
Prexton Therapeutics is a biopharmaceutical company that concentrates its efforts on developing novel compounds for treatment of the Central Nervous System (CNS) i.e the brain and spinal cord.
Its latest offering has now graduated to phase II clinical testing in Parkinson’s Disease and will consist of 165 patients in six European countries (UK, Germany, Italy, Spain, Austria and France).
The drug candidate is called Foliglurax and the study is double-blind, randomized, placebo-controlled parallel-arm phase II (phew! Try saying that after a couple! For those of us who are confused by the above see an explanation at the end of this article) using subjects who are struggling with two major Parky problems: Wearing-off of Levodopa (more commonly known as going ‘off’ by those of us that experience it) and Levodopa-Induced Dyskinesia (LID) where we suffer involuntary movements that can progress to the point where we feel like marionettes with a sadist continually jerking our strings.
Okay, the phase II trial is aimed at assessing the safety and tolerability of this new drug but what exactly does Foliglurax do? It stimulates a compensatory neuronal system that activates a system target known as mGluR4 – a system which does not break down in Parky people. The goal is to treat motor symptoms such as resting tremor, rigidity, dyskinesia etc. by re-routing the ‘phone lines’ in our brains (of course it is much more complicated than that but lets keep it understandable). Why would we use this instead of levodopa? Levodopa is still the gold standard – it mimics the effects of dopamine but ever-increasing doses are needed as PD progresses until a point is reached where it causes problems like dyskinesia.
The phase I trials completed in September 2016 showed Foliglurax to be safe and well-tolerated, inspiring confidence in the CEO of Prexton, Francois Conquet. Prexton are recruiting for the phase II trials so if you want to find out if you can participate follow this link: https://clinicaltrials.gov/show/NCT03162874 At the moment only the contact in Austria is listed but it is still worth reading for its lists of requirements needed by patients and the other five countries (including the UK) will appear on this site over the next couple of months.
A final note: As promised earlier here is an explanation in plain English of what a medical trial called the following actually is:Double-blind, randomized, placebo-controlled parallel-arm phase II trial. A clinical trial involves humans and seeks specific answers about a drug or other type of treatment such as dietary change or massage.
Well-constructed trials use several methods of assessing information (data) to reduce or eliminate bias whether deliberate or unintentional. First, double-blind means that neither the patients nor the researcher know who is getting the ‘real’ treatment and who is getting the placebo. This prevents patients from bias in favour of or against the treatment as they have no idea whether they are on it or not and, because the researchers don’t know either, it ensures that bias towards or against the results from them is also impossible.
A placebo is an inactive substance (often a sugar pill) given to a patient in place of medication.In drug trials, a control group receives a placebo while another group is given the real drug (or other treatment) being studied. That way, researchers can compare the drug’s real effectiveness against the placebo’s imagined effectiveness. If placebo results match the real drug’s results it would be fair to say the drug does not work as the placebo result is purely derived from patients believing they are on the drug – as they say in religions the power of faith can be an amazing thing!
Placebo-controlled simply means that a control group receives a placebo. This sets it apart from studies that simply give participants a treatment and record the results.The highest-quality studies are also randomized, meaning that subjects are randomly assigned to placebo and intervention (real treatment) groups. The acronym DBRCT is commonly used for these types of studies. The last bit of this modern hieroglyph is the parallel-arm and this is nothing more than (for example) 2 trials running side-by-side to compare drug A with placebo effect B. It is common practice to switch the patients from A to B or vice-versa halfway through a long study to see what happens but in a parallel study patients are either on A or B for the whole of the trial.
And that’s that! Apologies to scientists and researchers who were bored reading this explanation but we all had to start somewhere and if you never became a medical student how would you know this stuff?