Amgen Update: No “Significant Delays” from COVID-19 Pandemic for KRAS Inhibitor

 

Like many biopharma companies, Amgen is evaluating how the COVID-19 pandemic is affecting its operations, supply chain and clinical trial programs. Amgen stated in an SEC filing, “An increasing number of clinical sites are restricting site visits and imposing restrictions on the initiation of new trials and patient visits to protect both site staff and patients from possible COVID-19 exposure. Given the safety concerns around COVID-19 and the associated risk to maintaining normal clinical trial operations, we are making decisions study-by-study and country-by-country to minimize risk to the patients and facilities.”

 At the top of the list of interest for many investors and analysts is how the pandemic will affect the company’s clinical trial of AMG 510, a KRAS inhibitor that is currently in a “potentially pivotal” Phase II trial in specific lung cancer patients. The company indicates it doesn’t expect any “significant delays,” and plans to continue its clinical trial program fairly uninterrupted, although there may be small delays depending on the course of the pandemic.

The company’s Phase III trial in collaboration with AstraZeneca of tezepelumab in asthma is also fully enrolled and the company does not expect delays. And, the Phase III heart failure trial in collaboration with Cytokinetics of omecamtiv mecarbil is also fully enrolled and expected to continue uninterrupted.

Amgen indicates new patients will be allowed to sign up for studies if there is potential for “significant benefit in a serious or life-threatening condition” and if the sites allow new patients to be enrolled safely.

Amgen and the Amgen Foundation have committed up to $12.5 million to support COVID-19 relief efforts in the communities where its staffers live and work. They will be used for emergency response in its U.S. and international communities, patient-focused organizations and international relief efforts by Direct Relief and International Medical Corps.

For its own employees, the company has committed to continuity pay and providing staff working from home in the U.S. and Puerto Rico a monthly stipend for home broadband Internet access and an allowance for necessary home office equipment.

In addition, on March 28, Amgen announced positive data from the  BEIJERINCK clinical trial of Repatha (evolocumab) in patients who are HIV-positive with high low-density lipoprotein cholesterol (LDL-C) despite stable background lipid-lowering therapy. The trial showed that Repatha significantly decreased LDL-C. The company presented the results during the virtual American College of Cardiology’s 69^th Annual Scientific Session. The data was also published in the Journal of the American College of Cardiology (JACC).

“Certain antiretroviral treatments for HIV can increase LDL-C and change the lipid makeup of people living with HIV,” said David M. Reese, executive vice president of Research and Development at Amgen. “This study increases our overall evidence base for Repatha, but also provides us with a better understanding of cholesterol management for this under-represented patient population. These positive results show that Repatha can help these patients lower their LDL-C, one of the most important modifiable risk factors for cardiovascular disease.”

The Phase IIIb BEIJERINCK trial is part of the company’s PROFICIO program, which so far consists of 35 clinical trials including more than 41,000 patients around the globe and more than 80 real-world evidence studies.