Biogen and Eisai announced this week that they are pulling the plug on three additional phase 3 Alzheimer’s trials of investigational oral beta amyloid therapies (BACE inhibitors) over safety concerns.
The companies previously had halted two phase 3 trials of anti-beta amyloid drug aducanumab after a data safety monitoring board (DSMB) review of interim data concluded the treatments were unlikely to benefit patients (CenterWatch Weekly, April 29, 2019).
The most recent trials, of BACE inhibitor elenbecestat, were cancelled after the DSMB judged the treatments being tested to have an unfavorable risk-benefit ratio.
The studies had enrolled more than 2,000 patients globally with mild cognitive impairment with confirmed amyloid pathology in the brain. Investigators will contact study participants to discontinue the treatment.
The cancellation of the elenbecestat trials will not impact the companies’ study of the anti-amyloid beta protofibril monoclonal antibody BAN2401, Biogen says.
In the wake of a clinical hold placed on one of its oncology trials by the FDA, Amgen has decided voluntarily to halt recruitment for a similar study.
Amgen’s phase 1 dose-escalation trial of AMG 397 carried a risk of cardiac toxicity in patients, the FDA said, and should be halted.
The company determined a second oncology drug, AMG 176, was too similar in mechanism of action to AMG 397 to risk treating patients in the first-in-human trial for which it had started recruiting.
The AMG 397 trial began recruiting in August 2018 and had enrolled 24 subjects globally, with a completion target of August 2020. The AMG 176 study was a global phase 1 trial initiated in June 2016 and expected to be completed in April 2024.
A collaboration between the FDA and CluePoints to identify data anomalies in clinical trials will continue another two years.
The three-year-old cooperative research and development agreement, created to develop software that can indicate potential data problems in individual trials and help the FDA identify sites for inspection, has been extended to 2021.
Further analyses will include geographic region, country and supervising contract research organizations CROs.
Janssen has developed a voice-enabled software tool that allows clinical trial participants to respond to and ask questions using an app on their smartphone.
The voice-enabled technology collects information from patients using questions — such as whether they are experiencing pain — programmed to inquire at certain times during the trial. These questions are then answered verbally by the patient and the answers are recorded.
An algorithm then decides whether to provide an immediate personal follow-up or capture the recording for future analysis.
The software can provide patients with real-time answers to questions regarding their disease state, about the trial generally, or about scheduled visits.
The application is being tested by a group of patients receiving treatment for chronic conditions at Brigham and Women’s Hospital in Boston.
Janssen expects to initiate another study in early 2020, with the goal of providing the technology for broad use in clinical trials by the end of the year.
NIH has granted healthcare provider MaineHealth $5.1 million to create a clinical research center that will give cancer patients in the state access to clinical trials closer to home.
The MaineHealth Cancer Care Network Lifespan Program will allow MaineHealth, the state’s largest provider network, to serve a minimum of 85 patients initially with the potential to serve hundreds over its six-year term.
The program will be the only oncology program in northern New England to enroll patients — including children — in clinical trials at every stage of the cancer continuum.
PharmaVOICE has named Donald Deieso, executive chairman and chief executive officer of WCG Clinical, as one of the life science industry’s top 100 most inspiring leaders of 2019.
Deieso, who also received the honor in 2016, was commended by PharmaVOICE for his “never-wavering integrity and human-centric approach to problem-solving.”
Since taking over as CEO in 2012, Deieso has grown WCG to 15 times its original size, with 28 locations in eight different countries.