An anticlotting therapeutics developer utilizing aptamers is raising $13.5 million as the company seeks to move its lead drug through Phase 3 clinical trials, according to a document filed with the Securities and Exchange Commission.
So far, Regado Biosciences has raised nearly half that amount in debt and equity. Last year, the biotechnology company revealed positive results for its lead drug for arterial thrombosis indications in a Phase 2 study. The drug, REG1 is intended to provide physicians with a more effective option to control bleeding and ischemic events in acute coronary syndrome patients undergoing percutaneous coronary intervention, for example. A clinical program in open heart surgery, including coronary artery bypass grafting and valve repair/replacement, is also under development, according to the company’s website.
The aptamers used in the therapeutic are developed through a licensed in vitro process for selecting and amplifying RNA molecules to bind with a specific molecular target. The in vitro process is systematic evolution of ligands by exponential enrichment, or SELEX. The result is molecules that behave like proteins more than the nucleic acids. By going through this process, aptamers are able to be more effective at going after molecular targets like growth factors, enzymes, immunoglobulins, receptors and viral proteins.
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Other drugs in its pipeline include REG2, a subcutaneously administered depot formulation of pegnivacogin paired with the IV bolus formulation of anivamersen for use in venous thrombosis indications such as venous thromboembolism (prophylaxis in patients undergoing abdominal surgery. It has completed single escalating dose phase 1 clinical testing (the first successful subcutaneous application of an aptamer in humans) and is planned to be studied in a multiple escalating dose clinical trial.
REG3, an antiplatelet therapy to treat diabetic vasculopathies, is in Phase 1development.
Of the 21 clinical trials using aptamers listed on the clinical trials.gov website, the majority are for drugs for macular degeneration. The only aptamer-based drug approved by the U.S. Food and Drug Administration to date is for age-related macular degeneration called Macugen from OSI Pharmaceuticals (formerly known as EyeTech Pharmaceuticals).