Radius Health Shares Details About Cannabidiol-based RAD011 Program
Radius Health is sharing more details about RAD011, its investigational cannabidiol-based oral therapy meant to reduce excessive appetite, or hyperphagia, in people with Prader-Willi syndrome (PWS).
Its fact sheet contains not only results from previous preclinical and clinical studies, but also the design of the upcoming pivotal Phase 2/3 clinical trial, dubbed SCOUT-015 (NCT05098509), to test the therapy in PWS patients.
According to a blog post from Prader-Willi Syndrome Association USA, Radius is currently recruiting sites for the SCOUT-015 study, which is not yet enrolling patients. The trial is anticipated to start in early February and its results, if positive, may support a future regulatory application seeking the therapy’s approval.
Cannabidiol (CBD), the major non-psychoactive component in the cannabis plant, has gained increasing interest as a potential treatment for several health conditions based on its suggested anti-inflammatory, immunomodulatory, antioxidant, and neuroprotective properties. It has been approved to treat certain seizure-related conditions.
Previous studies have suggested that CBD may also help reduce appetite. While its exact mechanism of action in controlling hunger is unknown, it likely involves the suppression of cannabinoid receptors known to promote appetite and an increase in cellular metabolism, according to the fact sheet.
RAD011, initially developed by Benuvia Therapeutics, is an oral, strawberry-flavored solution of a lab-made version of CBD. It is being developed by Radius to ease hyperphagia in PWS, a hallmark symptom that is associated with obesity and life-threatening behaviors when seeking food.
In previous preclinical studies, the therapy showed promise in different animal and cellular models. Also, its safety and tolerability data support the dose levels selected for SCOUT-015, Radius stated.
To date, RAD011 has also been evaluated in nine clinical trials involving a total of 180 people, with ages ranging from 2 months to 55 years, and lasting from 13 days to 54 weeks (over one year). Participants included healthy volunteers and people with PWS or other neurological conditions.
Results showed that CBD absorption by the body was improved and more consistent when the therapy was taken with food. The most commonly reported adverse event was mild to moderate diarrhea.
RAD011 received fast track and orphan drug designations in the U.S. for hyperphagia in PWS patients. These designations are meant to accelerate the therapy’s clinical development and regulatory review process.
The Phase 2/3 SCOUT-015 study, expected to involve more than 30 sites worldwide, will evaluate the safety and effectiveness of RAD011 in nearly 200 people, ages 8–65 years, with genetically confirmed PWS. Its design was based on recommendations from the U.S. Food and Drug Administration that were shared with Radius in a previous meeting with the agency.
To be eligible, patients must not have used cannabis or related products and weight loss agents within one month prior to study entry, or been exposed to new food or environmental restrictions in that same period.
In the trial’s Phase 2 portion, participants will be randomly assigned to receive an oral solution of either one of three doses of RAD011 or a placebo, twice daily with food, through a plastic syringe.
This phase will assess the safety and tolerability of the three doses of RAD011, and an independent data monitoring committee will recommend the dose or doses to move to the Phase 3 portion, which will investigate the therapy’s safety and effectiveness.
SCOUT-015’s main goal is to assess changes in hyperphagia, as measured by the validated Hyperphagia Questionnaire for Clinical Trials. Secondary goals include changes in irritability, a hyperphagia-related behavior, and overall disease severity, all assessed through week 34 (nearly eight months).
Top-line data are anticipated in the second half of 2024.
After completing the trial, eligible patients may choose to enroll in a long-term extension safety study, called SCOUT-016.
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