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Collaborators seek MS biomarkers
LA JOLLA, Calif.—Regulus Therapeutics Inc. has entered into collaboration with Biogen Idec to identify microRNAs as biomarkers for multiple sclerosis (MS). Per the transaction, Biogen Idec will make an investment in Regulus in addition to upfront and milestone payments.
The key objective of the collaboration is to identify microRNA biomarkers in the blood of patients with MS. Regulus believes that microRNA biomarkers may be used to select optimal patient segments in clinical trials, develop companion diagnostics and monitor disease progression or relapse.
Regulus, a biopharmaceutical company founded by Alnylam Pharmaceuticals and Isis Pharmaceuticals, announced in August that it has filed a registration statement on Form S-1 with the U.S. Securities and Exchange Commission relating to a proposed initial public offering of shares of its common stock. Neither the number of shares to be offered nor the price range had been determined at that time. Although left unstated—all Regulus offered was that the "company's executives are not available for comments at this time"—it is apparently due to the pending Regulus IPO that neither Regulus nor Biogen would comment further on their collaborative efforts.
Their joint statement read: "Utilizing innovative technology such as biomarkers can help us make more informed decisions earlier in clinical development and is key to our overall company strategy to enhance early-stage discovery efforts. We're excited to collaborate with Regulus to seek to identify biomarkers in MS patients, and are hopeful it can speed the work we're doing to bring new, effective treatments to market for patients with MS."
"Regulus is delighted to form a collaboration with Biogen Idec, a biotechnology pioneer with more than 30 years of innovative contributions to the industry," says Dr. Garry E. Menzel, chief operating officer and executive vice president of finance at Regulus. "This collaboration allows us to further explore our proprietary microRNA biomarker platform with Biogen Idec's additional resources and expertise. We believe that identification of microRNAs as biomarkers for multiple sclerosis may advance the treatment of this devastating disease."
Regulus is advancing multiple microRNA therapeutic programs to the clinic in the areas of fibrosis, HCV infection, immuno-inflammatory disease, metabolic disease and oncology. MicroRNAs are small RNA molecules, typically 20 to 25 nucleotides in length, which do not encode proteins, but instead regulate gene expression. More than 500 microRNAs have been identified in the human genome, and more than one-third of all human genes are believed to be regulated by microRNAs. MicroRNA expression, or function, has been shown to be significantly altered in many disease states, including oncology, fibrosis and metabolic diseases. Regulus believes that microRNAs are clinically relevant therapeutic targets and may be ideally suited as biomarkers for these disease states and others, like MS. Emerging data has demonstrated that microRNA signatures in blood can mimic the expression profile observed in disease tissues. Regulus has a comprehensive intellectual property estate and oligonucleotide technology know-how.
In addition to its collaboration with Biogen Idec, Regulus has formed strategic alliances with AstraZeneca, GlaxoSmithKline and Sanofi. Earlier this year, the company presented data from its proprietary lead program targeting microRNA-33a/b (miR-33a/b), which is currently in preclinical development for the treatment of atherosclerosis.