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demonstrated a proof of concept, and that he had just spoken with one of the investigators, Paul Miller (the medical director for the Colorado Center for Bone Research) and was planning the next steps in development.
Miller didn’t return calls seeking comment about the study.
“If you ask the question of can you achieve delivery transdermally such that you can show a dose-related increase in [bone mineral density], that’s the proof of concept that’s been achieved,” Ward said.
Osteoperosis drugs are typically approved by the FDA based on two measures: a statistically significant increase in bone mineral density (essentially, the strength of one’s bones), and a reduction in bone fracturing.
Although it’s always difficult to compare one study to another, the results Radius saw with its patch are modest compared with Lilly’s billion-dollar drug teraparatide. The Lilly drug was approved based on a study showing increases of 9.7 percent and 2.6 percent in bone mineral density of the lumbar spine and hip, respectively, over the course of 18 months. Harvey points out that the patch is tracking ahead of Eli Lilly’s drug in terms of hip bone strength if it were to continue forward on the same trajectory in a longer-term study. Radius hasn’t said how its drug performed at lower doses, and also hasn’t disclosed any information regarding the fracture rates of the patients in its study.
Radius also appears to have gotten the data in September, and didn’t disclose anything about it for two months, until the Nov. 14 quarterly filing.
“We were collecting the totality of the data. The data comes in batches,” Harvey says. “We are a reporting company so we had to make reference to it in our 10-Q, but…now we’ve had more time to clean [the data], analyze it, and interpret it.”
In sum, here’s the timeline of events at Radius this year:
March 12: Radius completes enrolling patients in a, 2,400-patient, 18-month late-stage clinical trial of BA058, an injectable anabolic drug for osteoporosis.
April 25: Radius raises $43 million from a group of investors led by F2 Biosciences III. That put the total amount the company has raised since inception at about $240 million.
May 13: Michael Wyzga says that Radius’ value could swing significantly upwards if the skin patch succeeds in a mid-stage trial. The data are expected in September, he says.
Nov. 11: Wyzga resigns, along with chief business officer Michael Franken (Wyzga agrees to stay on in an advisory role for six months).
Nov. 12: Fromkin is named president and CEO.
Nov. 14: Radius releases a 10-Q that reveals the first and only information about the study released so far. Here are the details.
Nov. 22: Fromkin resigns.
Nov. 26: Lyttle is named interim president and CEO.
Dec. 17: First press release since April 25. Ward is named president and CEO, succeeding Lyttle.