Investors in the pharma/biotech space look forward to pipeline updates from these companies. Their investment decisions are often based on such updates. Moreover, pharma/biotech companies invest significantly to develop their pipelines. Successful development and subsequent commercialization of pipeline candidates would go a long way in augmenting the top lines of these companies.
Regulus Therapeutics Inc. (RGLS) is no exception and is working hard to develop its pipeline. In keeping with its pipeline development efforts, the biopharmaceutical company initiated the dosing of healthy volunteers in a phase I study on its hepatitis C virus candidate RG-101. The study is designed to primarily evaluate the safety and tolerability of the candidate.
The study will also assess pharmacokinetics, viral load reduction and any potential impact of an oral direct-acting antiviral on the pharmacokinetics of RG-101. The company expects to come out with proof of concept results from the phase I study by Dec 31, 2014.
Regulus is developing RG-101 as part of its “road to clinic” strategy. Through the scheme, launched in Feb 2013, Regulus intends to develop its microRNA therapeutic pipeline in the direction of the clinic. Apart from RG-101, Regulus has nominated another microRNA candidate – RG-102 (alport syndrome) for clinical development.
Alport syndrome is a life threatening orphan disease driven by genetic mutations. Regulus has an agreement with Sanofi (SNY) on RG-102. Regulus has agreements with many other companies to advance its pipeline.
Regulus currently carries a Zacks Rank #3 (Hold). Some better-ranked biopharma stocks include Alexion Pharmaceuticals, Inc. (ALXN) and Gilead Sciences, Inc. (GILD). Both stocks carry a Zacks Rank #1 (Strong Buy).