Benzinga | Dec 8, 2021 09:04AM EST

Radius Announces wearABLe Trial Evaluating Abaloparatide Transdermal System Did Not Meet Primary Endpoint

* The wearABLe study did not demonstrate non-inferiority of abalo-TDS to TYMLOS(r)

* Lumbar spine BMD at 12 months vs. baseline for abalo-TDS was +7.1% vs. TYMLOS +10.9%

* Both abalo-TDS and TYMLOS 12-month results are considered clinically meaningful

* Abalo-TDS was well tolerated with no significant safety signals identified

* Trial data and technical details to be fully analyzed and then utilized as a basis for future plans

BOSTON, Dec. 08, 2021 (GLOBE NEWSWIRE) -- Radius Health, Inc. ("Radius" or the "Company") (NASDAQ:RDUS), today announced phase 3 topline results from the wearABLe study evaluating the non-inferiority (NI) of abaloparatide transdermal system (abalo-TDS) compared to abaloparatide subcutaneous injection (TYMLOS) 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."