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

Rhea-AI Summary

Radius Health announced the initiation of the SCOUT-015 pivotal study for RAD011, a synthetic cannabidiol solution targeting hyperphagia in Prader-Willi Syndrome (PWS), affecting 20,000-30,000 patients in the US. The trial, currently featuring 9 active US sites, aims for over 30 global locations and includes multiple dose assessments. RAD011 has received Orphan Drug Designation and Fast Track status from the FDA. Presentations about SCOUT-015 are planned at upcoming conferences. Radius continues to seek patient recruitment to advance this critical clinical trial.

Positive

• Initiation of SCOUT-015 trial for RAD011, targeting a rare disease with significant unmet need.
• Orphan Drug Designation and Fast Track status from the FDA for RAD011.
• Multiple global sites planned for recruitment enhancing trial reach.

Negative

• None.

• 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)”
    Presenter: Dr. Anthony Goldstone (UK), co-Lead PI
  • [part of] Oral presentation (by-invitation only): a closed door KOLs meeting discussing all the studies a day prior to the main sessions
    Presenter: Dr. Deepan Singh (USA), study PI will talk about ‘all studies he’s part of’ including SCOUT-015

• FPWR (Foundation for Prader-Willi Research)
  Place: Chicago, IL
  Dates: September 29-30

About RAD011

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 125 patients across multiple indications and has potential utilization in multiple neuro-endocrine, neurodevelopmental, or neuropsychiatric disease areas. Radius has initiated a seamless pivotal Phase 2/3 study for patients with Prader-Willi Syndrome.

About Radius
Radius is a global biopharmaceutical company focused on addressing unmet medical needs in the areas of bone health, neuro-orphan diseases, and oncology. Radius’ lead product, TYMLOS^® (abaloparatide) injection, was approved by the U.S. Food and Drug Administration for the treatment of postmenopausal women with osteoporosis at high risk for fracture. The Radius clinical pipeline includes investigational abaloparatide injection for potential use in the treatment of men with osteoporosis; the investigational drug, elacestrant (RAD1901), for potential use in the treatment of hormone-receptor positive breast cancer out-licensed to Menarini Group; and the investigational drug RAD011, a synthetic cannabidiol oral solution with potential utilization in multiple neuro-endocrine, neurodevelopmental, or neuropsychiatric disease areas, initially targeting Prader-Willi Syndrome, Angelman syndrome, and infantile spasms.

Forward-Looking Statements

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 the potential for RAD011 for the treatment of patients with PWS and ongoing clinical development activities with respect to RAD011.

These forward-looking statements are based on Radius 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, including the delay of reviews and approvals by the FDA and other regulatory authorities and delays in the supply of drug products; goals and expectations with respect to development and commercialization of RAD011; the risk that adverse side effects related to RAD011 are identified; risks related to manufacturing, supply and distribution of RAD011; and the risk of litigation or other challenges regarding Radius’ intellectual property rights. These and other important risks and uncertainties discussed in Radius’ filings with the Securities and Exchange Commission (SEC), including under the caption “Risk Factors” in Radius’ Annual Report on Form 10-K for the year ending December 31, 2021 and subsequent filings with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent Radius’ management's estimates as of the date of this press release. While Radius may elect to update such forward-looking statements at some point in the future, Radius disclaims any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing Radius’ views as of any date subsequent to the date of this press release.

Investor& Media Relations Contact

Ethan Holdaway
Email: investor-relations@radiuspharm.com 
Phone: (617) 583-2017

FAQ

What is the SCOUT-015 clinical trial for RDUS?

The SCOUT-015 clinical trial is a Phase 2/3 study evaluating RAD011 for treating hyperphagia in Prader-Willi Syndrome.

How many sites are involved in the SCOUT-015 trial for RDUS?

Currently, 9 US sites are activated, with plans for over 30 global sites.

What is the primary endpoint of the SCOUT-015 trial for RDUS?

The primary endpoint is the reduction of hyperphagia, along with key secondary endpoints.

When will presentations about the SCOUT-015 trial for RDUS take place?

Presentations will occur at various conferences from July to September.

What disease does RAD011 target in the SCOUT-015 trial for RDUS?

RAD011 targets Prader-Willi Syndrome, a neuro-endocrine orphan disease.