29 May 2020
Posted in Pharma
CVMD clinical trials disrupted by COVID-19 slow to resume and investigation of diabetes drugs intensifies, says GlobalData
The clinical trial landscape has had multiple disruptions due to the COVID-19 pandemic, including the cardiovascular and metabolic disorder (CVMD) space. Despite a few trials resuming, most remain suspended or postponed indefinitely. Within the past two months, there has also been a noticeable uptick in COVID-19-related trials that are focusing on diabetes drugs, according to GlobalData, a leading data and analytics company.
In March, the FDA published a guidance document to help sponsors keep their studies going despite the obstacles and uncertainties that the studies are facing during the pandemic. The guidance has since been updated on May 14. GlobalData believes that the guidance will prove especially useful for trials that have resumed after being disrupted by the pandemic.
According to GlobalData’s clinical trial database on May 28, there have been over 200 CVMD clinical trial disruptions due to the pandemic, with only a few CVMD trials (about 6%) resuming after being disrupted by the pandemic.
Jesse Cuaron PhD PPM, Associate Director at GlobalData commented: “The majority of resumed trials are now recruiting and are in Phase III development. Most of them are sponsored by big pharma, such as Boehringer Ingelheim and Novartis, and the disease indications for these trials include acute heart failure, atrial fibrillation, chronic heart failure, hypertrophic cardiomyopathy, and type 2 diabetes (T2D).”
A number of trials identified in GlobalData’s database have also indicated that diabetes drugs are being investigated in COVID-19 studies. These include AstraZeneca’s DARE-19 trial, the University of Milan’s SIDIACO trial, and the University of Miami’s study on the effects of DPP4 inhibition on COVID-19.
Cuaron continues: “The treatments being investigated belong to two main drug classes used to treat T2D: sodium-glucose co-transporter-2 and dipeptidyl peptidase-4 inhibitors.”
AstraZeneca’s Farxiga (dapagliflozin) is being investigated for the potential to reduce COVID-19 progression, complications, and all-cause mortality. Merck’s Januvia (sitagliptin) is being investigated to modulate the pulmonary inflammatory response in COVID-19 patients. Boehringer Ingelheim and Eli Lilly’s Tradjenta (linagliptin) is being investigated to reduce the severity of the COVID-19 infection.
Cuaron adds: “However, despite optimism around the concept of repurposing drugs, as seen with Farxiga, the endeavor is risky as SGLT-2 inhibitors can cause an array of serious side effects, including diabetic ketoacidosis.”