Amgen has become the latest biopharma to try to figure out the hit it may take to its pipeline timings amid the COVID-19 pandemic.
In what may be a relief for some investors, its big, highly anticipated KRAS drug AMG 510 is already fully enrolled, and the company doesn’t see any “significant delays” for results here. (Though that line doesn’t rule out any smaller delays.)
The biopharma is currently undertaking a “potentially pivotal” phase 2 for the KRAS inhibitor in certain lung cancer patients and has high hopes this med (which was one of the most talked about targets of 2019) will continue on its clinical path relatively uninterrupted.
The same goes for the tezepelumab phase 3 asthma study, which is partnered with AstraZeneca, and the omecamtiv mecarbil phase 3 heart failure study, which is being worked on alongside Cytokinetics.
These, too, are fully enrolled, and thus, Amgen said, “we do not anticipate significant delays in obtaining results.”
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But delays could still hit the biopharma. It said an “increasing number of clinical trial sites are restricting site visits and imposing restrictions” on new trials as well as patient visits to limit COVID-19 exposure.
Given this, it said it is making decisions “study-by-study” and “country-by-country” but has already temporarily paused enrollment/screening in clinical trials “where there is uncertainty around the ability of sites to ensure subject safety or data integrity at the present time.”
Amgen will allow patients to join studies where there is the potential for “significant benefit in a serious or life-threatening condition” and where site resources allow new patients to be safely enrolled and closely monitored.
It added: “We are actively implementing remote and local procedures per recent FDA guidance and working with investigators for appropriate care of these patients in a safe manner consistent with agency guidelines.”