A Small Company, A Big Idea

Implications: “Personalized medical diagnositics” looks to be evolving as a high impact area in neuropsychiatric drug development.  Such ‘genetic biomarker’ platforms, based on either pharmacogenetic profiles coming from DNA blueprints or gene products from a simple blood draw, aim to identify patients who are more likely to respond to a specific drug or less likely to have side effects.  The idea: select out a narrower patient population with a simple screening blood test but treat them with greater efficacy and fewer problems.   

Analysis: From a scientific standpoint, the genetic biomarker platform should ultimately have traction because it makes sense, can be easily demonstrated in research trials, and potentially provides very useful clinical information.  The science, however, is still in its infancy.  Currently there are no specific genetic biomarker tests that clinicians use for psychiatric disorders.  Vanda Pharmaceuticals and Clinical Data Inc hope to have their two CNS drugs, Iloperidone (an antipsychotic) and Vilazodone (an antidepressant) respectively, enter the market with pharmacogenetic platforms if the drugs are approved by the FDA.  So far, these markers don’t look to be the ultra-high efficacy predictive tests one would hope for but will represent important steps scientifically and through the regulatory pathway.  We will have to wait and see how clinicians may use these and whether managed care will be a friend or foe to the pharmacogenetics platform; I suspect the latter until the technology provides greater precision.  

Theragenetics, a small privately held UK company, is looking to crack into the antidepressant and antipsychotic drug space, as far as I can tell.  Their IP acquisition from Canada’s Centre for Addiction and Mental Health looks to be along the lines of identifying individuals at risk for SSRI side effects and they also carry IP positions for genetic markers predicting response to antipsychotic medication.   Exactly what Theragenetics has in hand is not that clear but one kind of pharmacogenetic test that could have profound clinical value would be one that identifies patients at risk of becoming manic on an antidepressant, an area that poses great clinical and research challenges.  Theragenetics is looking at all the right areas: schizophrenia, Alzheimer's dementia, depression, bipolar disorder, anxiety disorders and ADHD.  But they will have to compete against big pharma that is already establishing their own genetic biomarker platforms for their own family of drugs, not to mention a number of other like-minded companies and collaborative networks pursuing the same goals.