Radius Health’s skin patch for osteoporosis appears to have fallen short of expectations in a mid-stage clinical trial, leading to a roughly two-year delay in development and what’s been a revolving door of four CEOs over the past month, Xconomy has learned.
The Cambridge, MA-based company, which tried to go public last year, but ultimately withdrew its IPO application, has pinned much of its hope on a skin patch treatment for osteoporosis that could be an alternative to regular injections. The key test of this technology came this year in a 250-patient clinical trial that ended in August, and yielded data for the company before the end of September.
Radius hasn’t publicly released detailed results from that study. But, the company did say in a footnote of its quarterly filing with the Securities and Exchange Commission on Nov. 14 that the results “support the continued development of an injection-free delivery system.” Radius stopped short of saying, however, whether BA058-TD, its lead skin patch candidate, will be the product to go forward.
Radius noted that some patients developed immune system antibodies against the drug, although it said they were found in low concentrations, and didn’t appear to cause a safety problem. Still, antibody formation against any new drug can be a worrisome sign.
Radius executives, in an interview with Xconomy this week, now say they expect to file a new drug application for its injection-free technology in mid-2019. Nick Harvey, the chief financial officer of Radius, said the company originally expected to reach that milestone in 2017.
“We feel that there’s strong proof of concept in this initial patch formulation, and the company’s plan is to optimize the patch, just make it better, so the timeline stretched a little bit,” Harvey says. “We’re very pleased with the results.”
Radius hasn’t said whether it plans to present the data from the Phase II study of BA058-TD in a peer-reviewed journal or a scientific meeting. Radius executives said this week they are planning to issue a press release soon to summarize the results, as soon as they can get clearance from a partner.
One other thing appears in the Radius quarterly filing with the SEC that hasn’t been disclosed elsewhere—it’s changed CEOs three times since Nov. 11. One of the short-term CEOs, former Clinical Data leader Drew Fromkin, declined to comment on his exit, other than to say it was a “personal decision.” Radius chairman Kurt Graves didn’t respond to a request for comment this week on the executive changes.
Radius started up in 2003. It was originally known as Nuvios, but changed its name in 2005, the same year it acquired an osteoporosis drug—what’s now known as BA058—from France’s Ipsen. The draw was that BA058 is an anabolic drug that is supposed to build up bones, rather than just stop them from decaying further than they already have, like the generic bisphosphonates that women with osteoporosis are typically first prescribed. Radius has raised $240 million from investors like MPM Capital, BB Biotech Ventures, Brookside Capital and others to finance the effort. It merged with an unlisted shell company in 2011, and has reported publicly with the SEC since.
Still, this is the same approach that Eli Lilly used when it developed … Next Page »