August 15, 2022

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Radius Announces First Patient Randomized in the RAD011

  • Advances asset in the neuro-endocrine orphan disease space
  • SCOUT-015 medical demo now has 9 activated US internet sites and affected individual screening commenced
  • 30+ world-wide internet sites are planned for the seamless Period 2/3 pivotal demo
  • Main endpoint of hyperphagia supplemented by important 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 “Business”) (Nasdaq: RDUS) now declared the initial affected individual has been randomized in the Section 2/3 pivotal study, SCOUT-015, to appraise RAD011, a artificial cannabidiol oral remedy, for the procedure of hyperphagia and linked neuro-behavioral signs in Prader-Willi Syndrome (PWS), a exceptional neuro-endocrine orphan sickness which outcomes among about 20,000 and 30,000 patients in the US.

The SCOUT-015 medical study is a international randomized, double-blind, placebo-controlled study. It is a seamless Stage 2/3 design that enables for the analysis of many dose groups and Intent-To-Treat efficacy assessment with both of those Phase 2 and Period 3 cohorts.

At present, 9 US sites are activated for screening and client recruitment will continue on across the US and globally as non-US sites are activated.

RAD011 has Orphan Drug Designation and has been granted Speedy Keep track of by the U.S. Food and Drug Administration (Food and drug administration).

Paige Rivard, Main Govt Officer of Prader-Willi Syndrome Affiliation|United states of america, said, “We are psyched and encouraged by the accomplishment of this milestone and remain fully commited to supporting Radius’ recruitment and consciousness endeavours for their SCOUT-015 medical trial inside of our community of individuals, caregivers, and important belief leaders. Continued enrollment within just the demo is critically crucial to the improvement of RAD011, which if permitted, has the likely for substantial affect on the PWS local community and will bring a significantly-needed procedure decision to people with hyperphagia.”

Radius will give supplemental updates pertaining to the PWS trial with even further improvements of the software.

Conferences

There will be a quantity of SCOUT-015 shows at future conferences, including:

  • IPWSO (Global Prader-Willi Syndrome Organisation)
    Spot: Limerick, Ireland
    Dates: July 6-10
    • Poster presentation (general public) “SCOUT-015: Update on Worldwide, Randomised, Double-blinded, Placebo-managed, Seamless Stage 2/3 Analyze of Artificial Cannabidiol (CBD) Oral Answer in Prader-Willi Syndrome (PWS)”
      Presenter: Dr. Anthony Goldstone (Uk), co-Lead PI
    • [part of] Oral presentation (by-invitation only): a closed doorway KOLs meeting talking about all the research a working day prior to the key sessions
      Presenter: Dr. Deepan Singh (United states), research PI will speak about ‘all scientific studies he’s aspect of’ including SCOUT-015
  • FPWR (Foundation for Prader-Willi Investigate)
    Place: Chicago, IL
    Dates: September 29-30

About RAD011

Investigational drug RAD011 is a pharmaceutical-quality synthetic cannabidiol oral solution, created making use of standard pharmaceutical producing processes. The item has purity technical specs that meet up with standardized regulatory and high quality regulate prerequisites and, as opposed to the system of acquiring a plant-derived product, the artificial producing system usually permits elevated regularity and increased precision in the products provide. RAD011 has been assessed in about 125 individuals throughout a number of indications and has prospective utilization in numerous neuro-endocrine, neurodevelopmental, or neuropsychiatric illness areas. Radius has initiated a seamless pivotal Phase 2/3 study for individuals with Prader-Willi Syndrome.

About Radius
Radius is a world wide biopharmaceutical firm centered on addressing unmet professional medical desires in the locations of bone health, neuro-orphan health conditions, and oncology. Radius’ direct products, TYMLOS® (abaloparatide) injection, was approved by the U.S. Foods and Drug Administration for the cure of postmenopausal ladies with osteoporosis at substantial hazard for fracture. The Radius scientific pipeline includes investigational abaloparatide injection for likely use in the cure of gentlemen with osteoporosis the investigational drug, elacestrant (RAD1901), for opportunity use in the therapy of hormone-receptor constructive breast most cancers out-certified to Menarini Group and the investigational drug RAD011, a synthetic cannabidiol oral solution with potential utilization in several neuro-endocrine, neurodevelopmental, or neuropsychiatric disorder areas, in the beginning concentrating on Prader-Willi Syndrome, Angelman syndrome, and infantile spasms.

Forward-Searching Statements

This press release contains ahead-hunting statements inside the indicating of the Non-public Securities Litigation Reform Act of 1995. All statements contained in this push launch that do not relate to matters of historic simple fact must be deemed forward-looking statements, together with, with no limitation, statements relating to the likely for RAD011 for the therapy of clients with PWS and ongoing clinical progress activities with respect to RAD011.

These forward-hunting statements are based mostly on Radius management’s recent anticipations. These statements are neither promises nor guarantees, but entail recognized and unknown dangers, uncertainties and other crucial aspects that may perhaps bring about our precise final results, overall performance or achievements to be materially various from any long run success, efficiency or achievements expressed or implied by the ahead-seeking statements, which include, but not restricted to, the adhering to: the adverse effect the ongoing COVID-19 pandemic, which include the delay of testimonials and approvals by the Food and drug administration and other regulatory authorities and delays in the provide of drug products and solutions ambitions and expectations with respect to improvement and commercialization of RAD011 the possibility that adverse aspect consequences linked to RAD011 are discovered threats connected to producing, source and distribution of RAD011 and the possibility of litigation or other troubles concerning Radius’ intellectual house legal rights. These and other significant hazards and uncertainties discussed in Radius’ filings with the Securities and Trade Fee (SEC), which include below the caption “Risk Factors” in Radius’ Yearly Report on Kind 10-K for the calendar year ending December 31, 2021 and subsequent filings with the SEC, could bring about actual effects to differ materially from these indicated by the forward-on the lookout statements designed in this push release. Any this sort of forward-hunting statements depict Radius’ management’s estimates as of the day of this push release. Although Radius could elect to update this sort of ahead-looking statements at some stage in the future, Radius disclaims any obligation to do so, even if subsequent events bring about our views to modify. These ahead-searching statements must not be relied upon as symbolizing Radius’ views as of any day subsequent to the date of this press release.

Investor& Media Relations Make contact with

Ethan Holdaway
E-mail: [email protected] 
Mobile phone: (617) 583-2017