DUBLIN, Ireland ¿ Swedish pharmacogenomics firm Eurona Medical AB, of Uppsala, expects to release its first product, a genetic signature assay that predicts the responses of patients with hypertension to ACE inhibitor therapy, in its home market by the end of the year.
The company and collaborators at Uppsala University, Sweden, have shown that 73 percent of 31 hypertensive patients who tested positive for the genetic signature on which the assay is based responded well to ACE inhibitor therapy alone. In contrast, 42 percent of a control group of 71 hypertensive patients who tested negative for the same genetic signature responded well to the same regimen.
Eurona presented these findings at the Ninth European Meeting on Hypertension in Milan, Italy, last week.
The genetic signature used in the assay is based on a series of single nucleotide polymorphisms found in the renin-angiotensin-aldosterone system (RAAS), the biochemical pathway through which ACE inhibitors act. These were identified in an earlier retrospective study of genetic markers in the RAAS system of 91 hypertensive patients.
About 40 percent of the 50 million hypertension sufferers in the U.S. are either sub-optimally treated or have not yet reached their target blood pressure, according to Eurona Chairman Per Lindstrom. The company is commencing validation trials in the US, involving all of the country¿s major population groups, as part of its filing for premarketing approval there. ¿We have initiated contact with the FDA,¿ Lindstrom said. ¿That is ongoing. It¿s going to be a modular filing.¿
Euro na plans to develop genetic signature assays for the five other major classes of cardiovascular disease therapy. The company is adopting the same approach to treatments for depression and schizophrenia and to the use of radiotherapy in cancer treatment. It will extend the latter program to chemotherapy, once the newer generation of cancer drugs becomes established, Lindstrom said. It also plans to collaborate with pharmaceutical companies in drug discovery programs based on its detailed knowledge of disease-associated biochemical pathways. The company hopes to sign a partner before the year¿s end, Lindstrom said.
Eurona has raised US$15 million in total over three investment rounds of financing. Lindstrom said he would like to see Eurona have a product on the market before seeking a stock exchange listing. ¿In biotechnology, that can be very enabling for an initial public offering,¿ he said.