Regulus CEO heads to exit as company struggles with FDA hold

Regulus seemed to be in a good place just last year as its lead drug candidate performed well in a Phase 2 study for hepatitis C. Its main selling point was its quick form of action, treating patients in just a few weeks, which would have allowed the drug to capture a sliver of the hep C market.

This case looks increasingly unlikely as the FDA implemented a hold on the drug after a second patient developed jaundice whilst undergoing a drug trial with RG-101. Initially, the company expressed a belief that the hold could be lifted by the end of 2016. However, as that timeline passed, the company was forced to admit that it wouldn’t be able to lift the hold until the end of 2017 at the earliest.

The failure has cost the company’s CEO his job. Paul Grint announced that he was leaving the company alongside a restructuring of staff levels that will see 30% of staff leave their positions.

"We are very grateful for the leadership of Dr. Grint and the many contributions of our other impacted employees who have dedicated themselves to Regulus' efforts in advancing the science of microRNAs," said Stelios Papadopoulos, Chairman of the Board of Directors.  "We are confident that Regulus is well positioned for success under Jay's guidance."

As mentioned by Papadopoulos, Jay Hagan, former COO, has now stepped up to President and CEO of the company. The immediate decision to reduce staff levels could see the new CEO have a further $6 million to utilise, annually, to turn around the business. The main hope for the company lies in its RG-012 candidate, a treatment for Alport syndrome, currently undergoing Phase 2 studies.