|CORRECTION: Radius Health Announces Plans for Global Prader-Willi Syndrome Pivotal Study|
|By: GlobenewsWire - 23 Jul 2021||Back to overview list
BOSTON, July 23, 2021 (GLOBE NEWSWIRE) -- A correction has been issued for a release disseminated under the same headline on July 22nd at 9:00 am EST by Radius Health, Inc. (RDUS), please note that the corrected release contains the revised statement with the typographical correction as follows: “RAD011 is not scheduled as it does not have traceable amounts of THC,” which has been corrected from “does have.” This information is located in the last sentence of the last paragraph of the main body of the press release.
Radius Health, Inc. (“Radius” or the “Company”) (NASDAQ: RDUS) today announced that it has recently received the written meeting minutes from a June Type C meeting held with the U.S. Food and Drug Administration (“FDA”) regarding RAD011, a synthetic cannabidiol oral solution.
RAD011 is initially to be utilized for the treatment of Prader-Willi Syndrome (“PWS”). RAD011 has previously been granted Orphan Drug and Fast Track Designation by the FDA. Based on the feedback received, Radius plans on initiating a pivotal Phase 2/3 global study for patients with PWS.
The main highlights from the FDA meeting minutes are set out below:
Paige Rivard, CEO of Prader-Willi Syndrome Association USA said, “We are encouraged by Radius’ commitment to advance RAD011 for the treatment of debilitating symptoms associated with PWS, particularly hyperphagia. We look forward to supporting their team throughout their study by raising awareness of their planned study with key opinion leaders, caregivers and individuals within the PWS community, and providing a means to gather perspective of individuals with PWS and critical caregivers.”
Phase 2/3 Study
The proposed study parameters, informed by several global advisory board meetings completed with leading KOLs, PWS advocacy organizations, and feedback from the FDA, are highlighted below:
Liz Messersmith, Ph.D. in Neuroscience and Senior Vice President at Radius stated, “We have established an exceptionally strong and highly experienced team of dedicated clinical, medical, biometrics, advocacy, regulatory and CMC talent to execute the pivotal study for PWS.”
Dr. Messersmith added further that, “We intend to use PWS as the anchor indication for RAD011. Additional disease opportunities and clinical trial initiatives will be shared in due course.”
Strategic CRO Partner Selected & DEA Scheduling Guidance Received
Important to the initiation and execution of the SCOUT program, Radius will move forward with RAD011 as not scheduled under the Controlled Substance Act (“CSA”) based on guidance from the Drug Enforcement Administration (“DEA”). The guidance states if a product does not contain any quantity of synthetic THC (or any other controlled substance), it is not controlled under the CSA. RAD011 is not scheduled as it does not have traceable amounts of THC.
About Prader-Willi Syndrome
These forward-looking statements are based on 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 is having and is expected to continue to have on our business, financial condition and results of operations, including our commercial operations and sales, clinical trials, preclinical studies, and employees; quarterly fluctuation in our financial results; our dependence on the success of TYMLOS, and our inability to ensure that TYMLOS will obtain regulatory approval outside the U.S. or be successfully commercialized in any market in which it is approved, including as a result of risk related to coverage, pricing and reimbursement; risks related to competitive products; risks related to our ability to successfully enter into collaboration, partnership, license or similar agreements; risks related to clinical trials, including our reliance on third parties to conduct key portions of our clinical trials and uncertainty that the results of those trials will support our product candidate claims; the risk that adverse side effects will be identified during the development of our product candidates or during commercialization, if approved; risks related to manufacturing, supply and distribution; and the risk of litigation or other challenges regarding our intellectual property rights. These and other important risks and uncertainties discussed in our filings with the Securities and Exchange Commission, or SEC, including under the caption “Risk Factors” in our Annual Report on Form 10-K for the year ending December 31, 2020 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 management's estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim 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 our views as of any date subsequent to the date of this press release.
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