- Added 5,000+ new TYMLOS patients in Q2, 2021, up 40+% vs. Q2, 2020 and 3% vs. Q1, 2021
- ATOM and wearABLe abaloparatide Phase 3 trial readouts remain on track for 2H, 2021
- EU abaloparatide regulatory resubmission remains on schedule for Q4, 2021
- Prader-Willi Syndrome (PWS) pivotal Phase 2/3 study to be initiated in Q4, 2021 or Q1, 2022
- Q2, 2021 earnings results scheduled for
August 5, 2021
New patient adds for the
The Company’s focus on fracture patients and corresponding healthcare providers – as the primary patient target for TYMLOS – is deepening. To date in 2021, 80+% of our top 50 TYMLOS prescribers are fracture / bone health focused, a trend we see accelerating.
On the European regulatory front, Radius completed scientific consultations with several EU member states in Q1, 2021, submitted a letter of intent to resubmit, completed a dossier review with the EMA, and is on track refile in Q4, 2021.
The Company received clarity from the FDA following the Type C meeting in June. Radius plans to move forward with a seamless Phase 2/3 pivotal trial for PWS. RAD011 had previously been granted Orphan Drug and Fast Track Designation by the FDA.
Based on current plans, the pivotal trial will initiate in Q4, 2021 or Q1, 2022, with anticipated topline readout in the second half of 2024.
There are approximately 22,000 to 24,000 PWS patients in the
Radius’ goal: through the pivotal trial and subsequent data readout, demonstrate efficacy and safety for FDA approval, and to help patients living with PWS.
Radius is a commercial biopharmaceutical company committed to serving patients with unmet medical needs in endocrinology and other therapeutic areas. Radius’ lead product, TYMLOS® (abaloparatide) injection, was approved by the
About TYMLOS (abaloparatide) injection
TYMLOS (abaloparatide) injection was approved by the
About ATOM Phase 3 Study
The ATOM Phase 3 study is a randomized, double-blind, placebo-controlled study to assess efficacy and safety of abaloparatide injection in 228 men with osteoporosis. The primary endpoint is change in lumbar spine BMD at 12 months compared with placebo, and if successful, will form the basis of a supplemental NDA seeking to expand the use of TYMLOS to treat men with osteoporosis at high risk for fracture.
About the Abaloparatide Transdermal System and wearABLe Phase 3 Study
The abaloparatide transdermal system was developed in a collaboration between Radius and
About Prader-Willi Syndrome
PWS, an orphan disease, is a complex genetic disorder with clinical manifestations on the endocrine and neurological systems. Clinical signs of PWS develop throughout childhood, with hyperphagia and anxiety ranked as the key clinical features seeking medical attention by caregivers of individuals with PWS. Hyperphagia is a relentless, insatiable, pathological drive to eat that requires caregivers to strictly manage access to food through the locking of cabinets and refrigerators. PWS is recognized as the leading genetic cause of life-threatening obesity in children. As life-threatening hyperphagia persists into adulthood, metabolic syndrome expressed through obesity and diabetes can develop and contribute to morbidity and mortality. In addition to food-related behaviors, the behavioral symptoms commonly observed in PWS include high irritability, habitual skin picking, oppositional defiance and cognitive rigidity. There are currently no approved therapies to treat this disorder’s hyperphagia, irritability, or metabolic aspects. In the
Investigational drug RAD011 is a pharmaceutical-grade synthetic cannabidiol oral solution, manufactured utilizing traditional pharmaceutical manufacturing processes. The product has purity specifications that meet standardized regulatory and quality control requirements and, compared to the process of developing a plant-derived product, the synthetic manufacturing process usually enables increased consistency and greater precision in the product supply. RAD011 has been assessed in over 150 patients across multiple indications and has potential utilization in multiple endocrine and metabolic orphan diseases. Radius is initially targeting Prader-Willi syndrome (PWS) and anticipates initiating a seamless pivotal Phase 2/3 study for patients with PWS in the fourth quarter of 2021 or first quarter of 2022.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding our expectations with respect to the continued commercialization of TYMLOS in the
These forward-looking statements are based on management's current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: the adverse impact the ongoing COVID-19 pandemic is having and is expected to continue to have on our business, financial condition and results of operations, including our commercial operations and sales, clinical trials, preclinical studies, and employees; quarterly fluctuation in our financial results; our dependence on the success of TYMLOS, and our inability to ensure that TYMLOS will obtain regulatory approval outside the
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Source: Radius Health Inc.