Study Will Assess the Effectiveness of Statins in Older Adults

A $90 million award expected from the National Institute of Aging and the National Heart, Lung, and Blood Institute (NHLBI) will fund the largest pragmatic trial with placebo-controlled drug assignment to date. Building on its success in leading pragmatic approaches for clinical study design, the Duke Clinical Research Institute (DCRI) has been awarded funding to conduct a pragmatic trial studying the effectiveness of statins in older adults without known cardiovascular disease. Funding for the trial is expected to be spread over the next seven years.

The study, known as Pragmatic Evaluation of Events and Benefits of Lipid-Lowering in Older Adults (PREVENTABLE), will be funded by NHLBI, of the National Institutes of Health (NIH), and conducted in partnership with Wake Forest School of Medicine. PREVENTABLE also is the first statin trial with a non-cardiovascular primary outcome. Investigators will study whether statins could help prevent dementia or physical disability-the most important outcome for older adults looking to maintain independence. Few statin studies in primary prevention populations have included individuals aged 75 or older, leaving many unanswered questions for older adults.

PREVENTABLE will partner with PCORnet, the National Patient-Centered Clinical Research Network, and the National VA Network to identify and recruit 20,000 participants 75 years of age or older at 100 U.S. sites, as well as to help identify outcomes via electronic health records. Use of these two national resources is expected to enable investigators to enroll participants and collect health data faster and more efficiently than a traditional trial.

Medidata acquisition closes

The acquisition of Medidata Solutions, Inc. by Dassault Systèmes SE was completed late last month. Medidata offers clinical expertise and cloud-based solutions supporting the development and commercialization of treatments.

The acquisition positions Dassault Systèmes to be a key player in the digital transformation of life sciences in the age of personalized medicine and patient-centric experience through a comprehensive offering that reflects a deep understanding of healthcare, its ecosystem, and market needs. Medidata will operate as a Dassault Systèmes brand powered by the 3DEXPERIENCE platform. The life sciences industry will become Dassault Systèmes’ second-largest core business after transportation and mobility.

Under the terms of the agreement, first announced in June, Dassault Systèmes acquired all of the issued and outstanding common shares of Medidata for $92.25 per share in cash, representing a total enterprise value of approximately $5.8 billion.

Astellas and Pandion strike pact

Pandion Therapeutics, Inc. and Astellas Pharma, Inc. signed a license and collaboration agreement directed toward the research, development, and commercialization of locally acting immunomodulators for autoimmune diseases of the pancreas. The collaboration will allow the parties to combine Pandion’s modular biologics and functional immunology expertise with Astellas’ advanced therapeutics development and global commercialization capabilities for the treatment of autoimmune diseases.

Under the terms of the deal, Pandion will be responsible for design and discovery of bispecific drug candidates based on Pandion’s proprietary modular immune effector and tissue tether platform and Astellas will be responsible for conducting preclinical, clinical, and commercialization activities for the selected candidates developed during the collaboration.  

Parexel expands SCRS collaboration

Parexel announced the expansion of its collaboration with the Society for Clinical Research Sites (SCRS), the first and only global organization fully dedicated to representing the interests of clinical research sites. Parexel will participate as a Site Engagement Partner and lead a number of key initiatives focused on improving the patient experience in clinical trials. The company’s global site solutions team maintains a site alliance network of more than 500 sites and 17,100 investigators across the globe.

One initiative Parexel will work on with SCRS will be leading a site advocacy group (SAG) on diminishing patient burden in clinical trials, bringing sites and patients together to discuss patient perceptions of methods of reduction of patient encumbrance to participate in clinical trials.

CF ‘Path to a Cure’ launched

The Cystic Fibrosis Foundation unveiled its “Path to a Cure” last month, an ambitious research agenda to deliver treatments for the underlying cause of the disease and a cure for every person with cystic fibrosis (CF). The Foundation is challenging potential collaborators to submit proposals that will accelerate the pace of progress in CF drug discovery and development and intends to allocate $500 million to the effort through 2025.

The Foundation offers partners a range of resources to de-risk CF drug discovery and development, including the world’s largest network of CF clinical trial sites and a dedicated laboratory to support translational research for potential therapeutic programs.

First Ebola vaccine inches closer

The European Medicines Agency (EMA) announced its conditional marketing authorization of a vaccine used to prevent the spread of the Ebola virus. University of Florida researchers played an integral role in the design and analysis of trials testing the effectiveness of the vaccine, manufactured by Merck & Co. Conditional authorization brings the vaccine a major step closer to licensing, which will eventually make the vaccine more widely available to protect people who are at risk of contracting Ebola.

Alexion to purchase Achillion

Alexion Pharmaceuticals, Inc. and Achillion Pharmaceuticals, Inc. have entered into a definitive agreement for Alexion to acquire Achillion, a clinical-stage biopharma company focused on the development of oral small molecule factor D inhibitors to treat people with complement alternative pathway-mediated rare diseases, such as paroxysmal nocturnal hemoglobinuria (PNH) and C3 glomerulopathy (C3G).

- Staff and wire reports