Regulus Therapeutics (RGLS): A Hep C Phase 2 Play in the Making

Stephen L Kanaval  |

Regulus Therapeutics (RGLS) is Biopharmaceutical Company that developed drugs that target microRNAs. MicroRNAs are small non-coding RNA that play a role in gene expression and important cellular processes.

Targeting microRNAs can lead to affecting immune response, metabolism, viral replication and a myriad of other body functions. This company’s approach is a platform of anti-miRs that inhibit certain microRNAs. The company is also developing microRNA mimics for multiple therapeutic applications.

Regulus’ goal is to use this microRNA platform in the fight against Hepatitis C (HCV). The company is in clinical phase 2 on its RG-101 injection. Many investors and analysts seem optimistic even though the trial is now at a hold because of a patient getting jaundice. The RG-101 treatment is ambitious because of its simple 4-week regimen. Here was Paul Grint, President and CEO, on a call about the future of RG-101:

Much of what is being asked of us is information we have or can obtain over the next couple of months. We anticipate submitting the aforementioned information by early Q4. Once the FDA receives our written response, we will be notified of their decision within 30 days. Our strategy remains unchanged for RG-101. We are interested in developing a safe and effective treatment for HCV that could be administered in four weeks or less.

We believe such as regimen is highly differentiated and represents a significant improvement over current standard of care. This is being further validated by the market research conducted with physicians and payors. Over the next several quarters, we expect to report more data from these ongoing studies, which will help define the breadth of RG-101's potential and form the basis for the optimal commercialization and partnering strategy.

Many consider Regulus’ HCV treatment a serious competitor in the field because of its reduced treatment time. It also came back with a 97% cure rate in a recent study. Many medical regulators are looking at the drug and thinking, ‘a 97% cure rate and 4-week treatment time, where do I sign?Regulus Therapeutics (RGLS): A Hep C Phase 2 Play in the Making.

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