Trial of CBD-based RAD011 Randomizes 1st Patient to Dosing Group

Study will test effects of synthetic CBD oral solution on excessive hunger in PWS

Lindsey Shapiro, PhD avatar

by Lindsey Shapiro, PhD |

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The first patient has been randomly assigned to a dosing group in the pivotal Phase 2/3 SCOUT-015 trial, which will evaluate the safety and efficacy of RAD011, an investigational cannabidiol oral treatment, in people with Prader-Willi syndrome (PWS).

SCOUT-015 (NCT05098509) is designed to test the effects of multiple RAD011 doses on excessive hunger (hyperphagia) — a prominent symptom of PWS.

The trial is currently recruiting up to 220 people with genetically-confirmed PWS who are from 8–65 years old. Recruitment will take place at several sites in the U.S. and continue globally as new non-U.S. sites are added, with more than 30 locations planned, the therapy’s developer, Radius Health, stated in a press release.

The announcement was lauded by members of the PWS community.

“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,” said Paige Rivard, CEO of the Prader-Willi Syndrome Association USA.

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“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,” Rivard added.

Cannabidiol (CBD), the predominant non-psychoactive constituent of the cannabis plant, has gained attention as a possible treatment for several health conditions due to a range of proposed benefits, including anti-inflammatory, immunomodulatory, and neuroprotective effects. It is approved to treat certain seizure-related conditions.

An ability to reduce appetite is among the suggested effects of CBD, raising the possibility it may be beneficial for conditions marked by excessive hunger, like PWS.

Benuvia Therapeutics originally developed RAD011 as a lab-made, or synthetic, version of CBD with the same chemical structure as the naturally-occurring compound. Radius, which is currently developing the potential treatment, believes RAD011 may ease hyperphagia in PWS patients, helping to lower the risk of obesity and problematic behaviors associated with food-seeking.

The investigational medication has been granted orphan and fast-track designations by the U.S. Food and Drug Administration, both of which are intended to speed a treatment’s development toward regulatory approval.

RAD011 has been evaluated in a total of nine preclinical and nine clinical studies since 2015. A total of 180 individuals — including healthy volunteers and people with PWS or other neurological disorders — have received RAD011. Participants in these trials ranged in age from 2 months to 55 years, and the studies lasted from 13 days up to 54 weeks (more than a year).

The most common side effect related to RAD011 treatment has been mild-to-moderate diarrhea, according to Radius.

Participants in the Phase 2 portion of SCOUT-015 will be randomly assigned to receive RAD011 at one of three oral doses or a placebo, twice daily with food, through a plastic syringe.

After evaluating the safety and tolerability of these doses, an independent data monitoring committee will recommend which doses should be used in the Phase 3 portion, which will mainly evaluate RAD011’s efficacy.

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The trial’s main goal is to assess changes in hyperphagia, as measured by the Hyperphagia Questionnaire for Clinical Trials, from the study’s start up to 34 weeks (8.5 months). Changes in irritability and hyperphagia severity (as assessed by clinicians) through week 34 will be evaluated as secondary measures.

SCOUT-015 is expected to end in the second half of 2024. Eligible participants from the trial will be able to enroll in a long-term safety study, dubbed SCOUT-016 (NCT05387798).

Radius has given or will give a number of presentations related to SCOUT-015 at conferences, including the recent International Prader-Willi Syndrome Organization conference, in Limerick, Ireland, and a research symposium held by the Foundation for Prader-Willi Research taking place Sept 29–30 in Chicago.