Radius Announces First Patient Randomized in the RAD011 Pivotal Trial for Prader-Willi Syndrome

• Advances asset in the neuro-endocrine orphan disease space
• SCOUT-015 clinical trial currently has 9 activated US sites and patient screening commenced
• 30+ global sites are planned for the seamless Phase 2/3 pivotal trial
• Primary endpoint of hyperphagia supplemented by key secondary endpoints
• SCOUT-015 presentations will be shared at numerous conferences July to September
  

BOSTON, July 07, 2022 (GLOBE NEWSWIRE) -- Radius Health, Inc. ("Radius" or the "Company") (Nasdaq: RDUS) today announced the first patient has been randomized in the Phase 2/3 pivotal study, SCOUT-015, to evaluate RAD011, a synthetic cannabidiol oral solution, for the treatment of hyperphagia and related neuro-behavioral symptoms in Prader-Willi Syndrome (PWS), a rare neuro-endocrine orphan disease which effects between approximately 20,000 and 30,000 patients in the US.

The SCOUT-015 clinical study is a global randomized, double-blind, placebo-controlled study. It is a seamless Phase 2/3 design that allows for the evaluation of multiple dose groups and Intent-To-Treat efficacy analysis with both Phase 2 and Phase 3 cohorts.

Currently, 9 US sites are activated for screening and patient recruitment will continue across the US and globally as non-US sites are activated.

RAD011 has Orphan Drug Designation and has been granted Fast Track by the U.S. Food and Drug Administration (FDA).

Paige Rivard, Chief Executive Officer of Prader-Willi Syndrome Association|USA, said, “We are excited and encouraged by the achievement of this milestone and remain committed to supporting Radius’ recruitment and awareness efforts for their SCOUT-015 clinical trial within our community of patients, caregivers, and key opinion leaders. Continued enrollment within the trial is critically important to the advancement of RAD011, which if approved, has the potential for high impact on the PWS community and will bring a much-needed treatment choice to patients with hyperphagia.”

Radius will provide additional updates regarding the PWS trial with further advancements of the program.

Conferences

There will be a number of SCOUT-015 presentations at upcoming conferences, including:

• IPWSO (International Prader-Willi Syndrome Organisation)
  Place: Limerick, Ireland
  Dates: July 6-10
  • Poster presentation (public) “SCOUT-015: Update on Global, Randomised, Double-blinded, Placebo-controlled, Seamless Phase 2/3 Study of Synthetic Cannabidiol (CBD) Oral Solution in Prader-Willi Syndrome (PWS)”