- 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
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
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
- 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)”
- 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
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
Investor& Media Relations Contact
Email: investor-relations@radiuspharm.com
Phone: (617) 583-2017
Source:
2022 GlobeNewswire, Inc., source