Armed with strong new data, Regulus aims to defy skeptics of its hep C injectable
- Regulus Therapeutics on Wednesday announced promising data for its hepatitis C injectable RG-101, which has been met with some skepticism since many of the revolutionary next-gen hepatitis C treatment options are oral formulations which are easier to administer.
- Researchers combined four weeks of treatment with RG-101 (two injections per day) with four weeks of currently approved oral medications. 97% of treated patients had a sustained response to the treatment 12 weeks out.
- Regulus asserts that a combination of injections and existing hep C combo pills could bring treatment time down significantly, from 8 to 12 weeks all the way to potentially 4 weeks.
The design of the phase 2 study involved giving 38 patients with untreated genotype 1 or 4 HCV two injections of RG-101 at the beginning and end of a 4-week treatment course. In between, those patients were treated with popular existing oral meds like Gilead's Harvoni and Bristol-Myers' Daklinza.
As The Street notes, there have been a couple of patients who experienced serious adverse events. But it's unclear at this point if that was related to the Regulus treatment.
The argument for convenience in this case seems difficult to make, as the introduction of oral treatments for HCV with high cure rates, and in most cases, without the need for interferon or ribavirin is a major breakthrough.
The re-introduction of injectables will most likely seem like a step backwards for patients. Then again, the pricing argument and shorter treatment time potential could hold some weight.