Radius Health announces results from the wearABLe trial evaluating abaloparatide transdermal system in postmenopausal women with osteoporosis.
The wearABLe study did not meet its primary endpoint of NI for abalo-TDS 300 micrograms (ug) vs. Tymlos 80 ug in the percent change from baseline in lumbar spine (LS) bone mineral density (BMD) at 12 months based on a NI margin of 2.0%.
Primary Endpoint : Abalo-TDS group demonstrated an increase of 7.1% (95% CI: 6.2, 8.0) vs. baseline Tymlos group demonstrated an increase of 10.9% (95% CI: 9.9, 11.8) vs. baseline Treatment difference: -3.7% (95% CI: -5.0, -2.4).Secondary endpoints: Percent change in total hip and femoral neck BMD at 12 months vs. baseline: Abalo-TDS group: total hip and femoral neck BMD increased by an avg. of 2.0% and 1.9% Tymlos group: total hip and femoral neck BMD increased by an avg. of 3.7% and 3.4%. Safety Results; Incidence of severe or serious treatment-emergent adverse events (TEAEs): similar in both groups More subjects in the abalo-TDS group reported TEAEs related to the application site as compared to the Tymlos group. Fewer subjects in the abalo-TDS group had TEAEs leading to study drug withdrawal, interruption, or discontinuation than in the Tymlos group
Data from previous Tymlos registrational study (ACTIVE, BA058-05-003); Tymlos group LS BMD increase at 12 months vs. baseline: 9.1% Teriparatide group LS BMD increase at 12 months vs. baseline: 7.9% The wearABLe study data and technical details are to be analyzed and utilized as a basis for future abalo-TDS plans.
Bruce Mitlak, MD, Chief Medical Officer, commented, “We are pleased to see a clinically meaningful increase in lumbar spine and hip bone mineral density versus baseline for patients receiving the transdermal system. Despite missing the non-inferiority margin, the transdermal system demonstrated a clear bone building benefit to patients and was well tolerated with less than 10% of patients experiencing TEAEs leading to discontinuation.” Dr. Mitlak continued, “Tymlos is an outstanding molecule – it exceeded our efficacy expectations in this trial and with the recently completed ATOM study in men with osteoporosis, we remain highly committed to meeting the needs of our patients.”
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