Radius Reports Positive Phase 3 Results For TYMLOS Subcutaneous Injection In Males With Osteoporosis

(RTTNews) - Radius Health Inc. (RDUS) announced positive results from the ATOM Phase 3 Study evaluating TYMLOS or abaloparatide 80mcg subcutaneous (SC) for use in males with osteoporosis. The company remains on track for an sNDA submission in the first quarter of 2022.

The study met its primary endpoint - the percentage change in lumbar spine (LS) bone mineral density (BMD) compared to placebo - demonstrating statistical significance after 12 months. Study participants receiving abaloparatide-SC experienced an average increase in LS BMD of 8.5% compared to patients receiving the placebo experiencing an average increase of 1.2%.

The study also met secondary endpoints, which measured the percentage change compared to placebo for lumbar spine BMD at 6 months, total hip BMD at 12 months, and femoral neck BMD at 12 months.

The company noted that the safety profile of abaloparatide in the ATOM study was consistent with results in previously reported trials.