- RAD011 is a pivotal-trial ready synthetic cannabidiol oral solution with potential utilization in multiple endocrine and metabolic orphan diseases
- Prader-Willi syndrome (“PWS”) will be the initial indication, which has been granted Orphan Drug and Fast Track Designation by the FDA
- Acquisition and associated PWS trial costs to be funded from existing operations
- Management to host conference call and webcast this morning at
8:15 a.m. ET
Under the terms of the agreement, Radius acquired RAD011 for
The Company has financed the acquisition through cash on hand and the utilization of
“This acquisition advances our business across several dimensions. It increases the optionality to the Company’s value proposition, leverages our endocrine expertise and adds a late-stage pivotal trial-ready orphan disease product to the existing Phase 3 programs for abaloparatide and elacestrant,” said Radius Chief Executive Officer,
“Benuvia is excited to partner with the leadership of
PWS is an orphan disease with major endocrine and behavioral manifestations and no FDA-approved therapies for the treatment of hyperphagia. Caregivers of these patients often prioritize hyperphagia, the most common genetic cause of life-threatening childhood obesity, and anxiety as the most important symptoms for treatment of the disease. From existing literature and previous clinical trial data generated, cannabidiol has a multifactorial mechanism of action showing clear biological activity against both of these symptoms.
The efficacy and safety of Benuvia’s synthetic cannabidiol oral solution has been assessed in over 150 patients across multiple indications. Existing data demonstrates that safety and tolerability have been favorable. In the PWS indication, efficacy data from an abbreviated Phase 2 trial with RAD011 is directionally supportive of reducing both hyperphagia as well as demonstrating a reduction in weight. The reduced appetite and associated weight reduction are further supported by additional RAD011 trials as well as published data from other botanical cannabidiol products.
Radius plans to promptly request a meeting with the FDA to discuss the initiation of a pivotal Phase 2/3 study for the treatment of patients with PWS. The study design will be informed by learnings from previous clinical studies that have been conducted in the PWS patient population. RAD011 was granted Fast Track Designation in 2017 and Orphan Drug Designation in
Conference Call & Webcast (with Slides)
Radius will host a conference call and webcast this morning,
For those unable to participate in the conference call or webcast, a replay will be available on
About Prader-Willi Syndrome
PWS, an orphan disease, is a complex genetic disorder with clinical manifestations on the endocrine and neurological systems. Clinical signs of PWS develop throughout childhood, with hyperphagia and anxiety ranked as the key clinical features seeking medical attention by caregivers of individuals with PWS. Hyperphagia is a relentless, insatiable, pathological drive to eat that requires caregivers to strictly manage access to food through the locking of cabinets and refrigerators. PWS is recognized as the leading genetic cause of life-threatening obesity in children. As life-threatening hyperphagia persists into adulthood, metabolic syndrome expressed through obesity and diabetes can develop and contribute to morbidity and mortality. In addition to food-related behaviors, the behavioral symptoms commonly observed in PWS include high anxiety, habitual skin picking, oppositional defiance and cognitive rigidity. There are currently no approved therapies to treat this disorder’s hyperphagia, anxiety, or metabolic aspects. In the
Cannabinoids can be classified into three groups: phytocannabinoids (Cannabis plant-derived), endocannabinoids (produced by body), or synthetic cannabinoids (pharmaceutically manufactured). The two most commonly researched cannabinoids are tetrahydrocannabinol (THC), the most potent psychoactive cannabinoid, and cannabidiol (CBD), which is not psychoactive. Within PWS, cannabidiol targets signaling pathways and receptors that regulate the physical symptoms of hyperphagia and anxiety. This multifactorial mechanism of action positions cannabidiol to interact beyond CB1 and CB2 receptors, including the body’s endocannabinoid system and inhibition of anandamide reuptake, activation of PPAR- γ, and agonism of 5HT-1A, which regulate food intake, metabolism, weight control, and anxiety. Cannabidiol may also improve other complications associated with PWS, including behavioral disorders.
Radius is a science-driven fully integrated biopharmaceutical company that is committed to developing and commercializing innovative endocrine therapeutics. For more information, please visit www.radiuspharm.com.
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 those related to Radius’ ability to absorb program costs, cost and revenue projections, the financial impact of the acquisition. These forward-looking statements are based on management's current expectations, and expected trial submission and completion timelines. These statements involve known and unknown risks and uncertainties that may cause our actual results, performance or achievements to be materially different from any expressed or implied by the forward-looking statements. These risks include, but are not limited to, the following: uncertainty regarding the results of regulatory submissions and oversight; success of our commercial operations; success of our clinical trials and preclinical studies; risks related to manufacturing, supply and distribution; success of any collaboration, partnership, license or similar agreements; achievement of milestones; receipt of royalties or other future contingent payments; ability to implement pricing increases. These and other important risks and uncertainties discussed in our filings with the
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Source: Radius Health Inc.