Radius osteoporosis drug bests placebo in PhIII; eyes 2017 FDA approval

Radius Health ($RDUS) has posted new results from its late-stage trial in women with osteoporosis as it looks to shore up its data ahead of an expected U.S. approval next spring.

The new data, published this week in JAMA, showed that 2,463 female osteoporosis patients in the ACTIVE Phase III trial, when treated with a daily injection of abaloparatide for 18 months, had a significantly greater reduction in the incidence of new vertebral fractures when compared to placebo.

It was a little less strong on nonvertebral fractures when compared to placebo, however, with a P value of 0.049--meaning it just squeaked into significance. But it still did manage to hit its trial targets.

Radius is currently set for an EU approval for its candidate by the end of the year, with the med also under FDA review, with a PDUFA date of March 30, 2017.

The Cambridge, MA-based biotech is hoping to beat out competition from Amgen ($AMGN) and its partner UCB for their experimental bone drug romosozumab (a.k.a. romo).

Back in March, romo--an antibody designed to block the protein sclerostin--achieved its Phase III BRIDGE study primary endpoint of increasing bone mineral density of lumbar spine at 12 months, when compared with placebo.

It also hit its secondary endpoints of bone mineral density increase of femoral neck and total hip at 12 months over placebo, and BMD increase of lumbar spine, femoral neck, and total hip at 6 months over placebo.

This came a month after the company posted generally positive results for the med in its FRAME study for women--although analysts were quick to note that the drug didn't perform as well as abaloparatide.

Both are looking to capture market share from Eli Lilly's ($LLY) rival blockbuster Forteo (teriparatide).

“The landmark ACTIVE trial results are important and further validate abaloparatide’s potential to consistently, substantially and rapidly reduce both new vertebral and nonvertebral fractures in postmenopausal women with osteoporosis,” said Dr. Paul Miller, medical director at the Colorado Center for Bone Research and lead author of the paper.

“Approximately two million osteoporotic fractures occur annually in the U.S., which create physical and psychological burdens for affected women by diminishing their independence and quality of life. There is a great unmet medical need for therapies which could provide more consistent potent and early benefits to patients.”

Abaloparatide works as a synthetic peptide that engages the parathyroid hormone receptor (PTH1 receptor) and designed to help with bone building activity.

Radius’ shares were up this morning on this news by around 1% at 10am EDT, but then quickly dropped into the red. The company currently has a market cap of around $2.33 billion.  

- check out the release

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