Clinical Data last week launched a service involving its SNP-genotyping panel for basic pain research, and the company’s research partner Algynomics hopes to integrate parts of the panel into a larger diagnostic over the next three to five years to help guide pain management in the clinic.
Using its own software, privately held Algynomics, which provided the SNPs for Clinical Data’s assay, is “developing, ultimately, a medical device that will capture neurological, psychological, as well as genetic information that can be used for diagnosis and treatment decisions” for chronic and acute pain management, Bill Maixner, the company’s founder, told Pharmacogenomics Reporter this week.
But the first step is to put the SNPs in the panel to use. At the moment, Clinical Data is offering Algynomics’ 3,000-SNP panel as a microarray service to academic and pharma researchers. In the future, the companies hope it will eventually appeal to drug and diagnostics makers addressing chronic and acute pain downstream.
Chronic and acute pain are prevalent in the US, and there is no shortage of drugs to treat them. But for many patients there is no satisfactory solution. Together, these factors might add up to a promising market for Clinical Data and Algynomics should pharmaceutical and diagnostics firms warm to the pharmacogenomics of pain.
Algynomics will probably select a diagnostic partner with “good distribution” that can eventually manufacture and commercialize the combined assay, said Maixner, who is also director of the Center for Neurosensory Disorders at the University of North Carolina at Chapel Hill.
Clinical Data will “play a very important role” in developing a combined assay, and Algynomics “very much hope[s] to see us further develop our relationship along these lines,” he said, stopping short of naming Clinical Data as a definite development partner.
For a combined test that physicians can use to classify patients, Algynomics needs to validate its pain SNPs in several clinical populations — a task that Clinical Data is helping to accomplish by offering the pain panel as a genotyping service.
The pain panel will help researchers “examine the genetic basis … of human pain sensitivity, pain conditions, and responses to existing and new pharmacological agents used to treat pain, inflammation, and mood disorders,” Clinical Data said in a statement.
The SNPs are concentrated in four major categories of genes associated with both chronic and acute pain: pain transmission; pain modulation; inflammatory responses; and affective mood.
Chronic and acute pain affects as many as 60 percent of adults in the United States, according to a 2005 survey conducted in part by Stanford University Medical Center. About 40 percent of respondents said their pain was chronic.
The American Pain Foundation lists arthritis, back and spine conditions, fibromyalgia, migraines and headaches, and neuropathic conditions as some of the main causes of chronic pain.
The survey, which queried 1,204 people, found that approximately 10 percent of adult Americans take prescription analgesics daily.
Maixner estimates that the treatment of acute and chronic pain constitutes a $125 billion market with about $32 billion in drug costs alone.
The market research firm Piribo estimates that the worldwide analgesic market was worth $50 billion in 2005, and that it will increase to $75 billion by 2010.
The pain panel could be useful for both academic and pharma researchers eager to stratify patients or for other functions, such as identifying placebo responders, said Maixner.
Asked which drugs the panel might be best suited to studying, Maixner said, “Almost all classes of analgesics — one would be able to do genetic stratification [with] almost all current drugs on the market using this panel of genes.”
However, no particular drug stands out as most likely to benefit from this kind of research, and no drug maker has heard about the panel yet, he said.
The pain SNP panel may be useful for understanding the effects of cox-2 inhibitors because of the deep links between pain and other bodily systems, such as the cardiovascular system, said Maixner.
Other drug classes for which the panel may be useful include opioids, anti-migraine agents, NSAIDs, anti-convulsants, sedative hypnotics, tricyclic anti-depressants, SSRIs, and some anti-seizure compounds.
The PharmGKB database contains some information from the scientific literature on the pharmacogenomic properties of several analgesics, as well as medical conditions that can cause chronic pain.