Radius Plans to Test Cannabidiol RAD011 in Global Clinical Study

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by Steve Bryson PhD |

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Radius Health plans to initiate a Phase 2/3 study to evaluate the safety and efficacy of its investigational therapy RAD011, a lab-made oral cannabidiol therapy to treat excessive appetite, or hyperphagia, in people with Prader-Willi syndrome (PWS).

The study, called SCOUT-015, is expected to begin by the end of this year or early in 2022, with top-line results anticipated in the second half of 2024.

“We are encouraged by Radius’ commitment to advance RAD011 for the treatment of debilitating symptoms associated with PWS, particularly hyperphagia,” Paige Rivard, CEO of Prader-Willi Syndrome Association USA, said in a press release.

“We look forward to supporting their team throughout their study by raising awareness of their planned study with key opinion leaders, caregivers and individuals within the PWS community, and providing a means to gather perspective of individuals with PWS and critical caregivers,” she added.

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The announcement comes on the heels of Radius receiving minutes from a recent meeting with the U.S. Food and Drug Administration (FDA) about further development of RAD011.

Highlights of the minutes included proper study design and selected outcomes, with marketing approval potentially dependent on the results of a single study. The acceptability of nonclinical data, which typically cover toxicology and pharmacology, to support the clinical trial is also required.

In addition, the path to approval is subject to the completion of food effect studies and a review of pharmacokinetics — how RAD011 is absorbed, passes through, and is eliminated from the body.

“We have established an exceptionally strong and highly experienced team of dedicated clinical, medical, biometrics, advocacy, regulatory and CMC [chemistry, manufacturing, and control] talent to execute the pivotal study for PWS,” said Liz Messersmith, PhD, senior vice president at Radius.

RAD011 is a synthetic version of cannabidiol, an active chemical of the cannabis plant that does not have mind-altering effects. The therapy is designed to ease hyperphagia, a prominent symptom of PWS as ranked by caregivers. The genetic disease is also characterized by poor growth and muscle tone, intellectual disability, and behavioral difficulties.

RAD011 is not scheduled under the Controlled Substance Act established by the Drug Enforcement Administration. It does not contain traceable amounts of tetrahydrocannabinol — the principal psychoactive component of cannabis — which is considered a controlled substance by the agency.

SCOUT-015 will be a placebo-controlled study to be conducted at more than 30 sites worldwide and is expected to enroll about 200 people, age 8 to 65 years, with genetically confirmed PWS. The Phase 2 portion will investigate the safety and tolerability of RAD011 across multiple doses, while Phase 3 will evaluate efficacy and safety.

The study’s primary goal is a change in hyperphagia scores as measured by the Hyperphagia Questionnaire for Clinical Trials. Eligible patients who complete the trial will be invited to enroll in the long-term extension safety study — SCOUT-016.

Radius recently acquired the development and commercialization rights to RAD011. So far, RAD011 has been evaluated in more than 150 study participants across multiple indications and has the potential to treat other rare metabolic and hormonal diseases, according to the company.

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“We intend to use PWS as the anchor indication for RAD011,” Messersmith said. “Additional disease opportunities and clinical trial initiatives will be shared in due course.”

Previously, the FDA granted RAD011 fast track and orphan drug designations, which provide regulatory and financial incentives to therapeutic development.