In this week’s roundup we look at promising results in a clinical trial leveraging an existing diabetes drug for the treatment of obesity, a new and less invasive treatment for sleep apnea, and a new technology in cardiac catheters. We also examine the impact of the pandemic on oncology trials and the challenges of developing new treatments for Alzheimer’s disease.
Each week, we highlight five things you need to know about in the life sciences industry. Here’s the latest.
On Feb. 10, Novo Nordisk released Phase III data on its latest obesity drug that showed one third of patients “lost more than 20% of their body weight during the 68-week trial,” with the average participant losing more than 33 pounds, and improvement in chronic risk measures. This drug is currently marketed as Ozempic and is used to treat diabetes. Now, as the Fierce Pharma piece linked above explains, Novo Nordisk is testing the drug under the name semaglutide (in higher dosage quantities) for the specific treatment of obesity. The company expects a decision from the FDA about whether the drug can be marketed to treat obesity by mid-2021.
The prevalence of obesity in U.S. adults was 42% between 2017 and 2018, according to the CDC, and the “estimated annual medical cost of obesity in the United States was $147 billion in 2008 US dollars.” Heart disease, diabetes, sleep apnea, and some forms of cancer are just a few of the catalysts in the search for the holy grail of a safe and effective weight loss drug.
There was a 60% reduction in new oncology trials globally during the first wave of the COVID-19 pandemic (from January to May 2020), according to new study using data from Medidata and published by the JAMA network. This drop will likely delay and in some cases stop the development of many new cancer therapies. More broadly, the results of the study raise concerns that the decrease in trial launches will likely have a significant, lingering impact on scientific research for other diseases as well.
Medical device company MedLumics will use a recent fundraising round to move from preclinical development to the company’s first-in-human clinical tests for its heart ablation catheter, according to this Fierce Biotech piece. The technology has the potential to help people with atrial fibrillation (AF), a serious heart condition that causes an irregular heartbeat. The minimally invasive technique uses light to accurately identify the ablation lesions that cause AF and then destroy the tissue causing arrhythmia.
MedLumics has said that “recurrence of AF after catheter ablation is currently high, with 20% of patients needing a repeat procedure within a year,” according to this article in Pharmaphorum. If successful, MedLumics’ new procedure will significantly improve results and reduce the need for a repeat procedure. Some estimates suggest the market for catheter ablation of AF could be as high as $1 billion a year.
Last week, the FDA approved a new daytime use device for patients with mild cases of sleep apnea, an encouraging development for sleep apnea patients looking for an alternative to more disruptive masks and CPAP machines that can only be used at night. The new device delivers electrical stimulation to train the patient’s tongue to avoid blocking the airway while sleeping.
While obstructive sleep apnea may be a risk factor for severe COVID-19 cases, the disease on its own can cause serious problems such as heart attacks, glaucoma, diabetes and more, according to the FDA. Sleep apnea afflicts over 20% of obese adults, according to a pulmonary and sleep medicine specialist at Johns Hopkins, and more than 40% of adults are clinically obese.
Successfully bringing new, effective treatments to market for Alzheimer’s Disease has always been a challenging proposition. This week, Cortexyme was reminded of this when its GAIN trial was put on a partial hold by the FDA. This partial hold means the company will halt enrolling new patients, though existing patients will continue to receive their assigned doses until they reach the trial’s one-year end-point. Although the adverse events that caused the hold represent a setback for Cortexyme, they were reversible and the company remains optimistic that the trial overall will meet its endpoints.