Madrigal Pharmaceuticals’ CEO Paul Friedman, M.D., is stepping aside so Sanofi’s Bill Sibold can take the reins ahead of a possible FDA greenlight for what would be the first treatment approved for nonalcoholic steatohepatitis (NASH).
Sibold joins the Pennsylvania-based biotech from Sanofi, where he was executive vice president of specialty care and president of North American operations. In those roles, Sibold oversaw 10,000 employees and grew his operations into the pharma’s largest global business unit. This included leading the launch of Regeneron-partnered immunology superstar Dupixent.
The exec departed Sanofi at the end of August after 12 years with the company. The Big Pharma’s current head of specialty care in North America, Brian Foard, has assumed Sibold’s post while the company searches for a permanent successor. Before Sanofi, Sibold also held leadership roles at Avanir Pharmaceuticals, Lycera Corp., and Biogen.
Madrigal’s progress up to this point has been guided by former CEO Friedman—who has now joined the company’s board of directors. Shares slid 8% this morning after the leadership change was announced to $179 apiece, compared to $196 at market close on Friday.
Sibold joins as Madrigal gears up to become a commercial organization with lead candidate resmetirom, which is awaiting FDA approval. An application has already been submitted on a rolling basis for an accelerated approval in NASH.
There are currently no approved therapies for the liver disease and only four investigational treatments in phase 3 development, including resmetirom. Analysts have agreed that Madrigal’s once daily, oral thyroid hormone receptor is likely to be the first NASH treatment to make it to market. Mizuho analysts have previously forecast that the biotech could see $1 billion in peak sales as the first in the indication.
In a second positive phase 3 readout shared last December, Madrigal showed that resmetirom hit both liver histological improvement endpoints that the FDA had proposed as reasonably likely to predict clinical benefit. In the study, 26% of patients on the 80 mg dose and 30% on 100 mg achieved the primary endpoint of a reduction in NASH activity score—which includes ballooning and inflammation—of two or more points as well as no worsening of fibrosis.
Resmetirom also led to a 24% and 26% improvement in the second primary endpoint measuring fibrosis in the low and high-dose groups, respectively. This compares to 10% and 14% for the two primary endpoints in the placebo arm.
“It is a great honor to join a company that is taking on a significant unmet need in medicine today, and I look forward to working with our executive team and our employees to write the next chapter of the Madrigal story together,” newly anointed CEO Sibold said in a Sept. 11 company release.