AstraZeneca downplays risk of COVID-19 to late-stage timelines

AstraZeneca has downplayed the risk COVID-19 poses to its clinical trial timelines, telling (PDF) investors it “does not expect material delays to anticipated dates of late-stage and lifecycle-management news flow in 2020 and 2021.”

The spread of SARS-CoV-2 beyond China led drugmakers including Bristol Myers Squibb, Eli Lilly and Pfizer to rethink their clinical research strategies, pause enrollment in ongoing trials and hold off on initiating new studies. With potential study subjects in lockdown and hospitals shifting focus from research to COVID-19 care, sponsors have been hit regardless of whether they have taken voluntary actions. 

Yet, AstraZeneca thinks its late-stage pipeline will emerge from the pandemic largely unscathed. The company’s phase 3 pipeline currently features seven programs, most of which are testing cocktails involving anti-PD-L1 antibody Imfinzi and CTLA-4 prospect tremelimumab. 

In a statement about its first-quarter results posted Wednesday, the Anglo-Swedish drugmaker outlined the mitigation strategies it has adopted to prevent material delays to the late-stage programs.

AstraZeneca is adopting “home-based treatment and monitoring options, moving patient recruitment to less-affected regions, and planning for accelerated recruitment once the pandemic has receded.” In doing so, AstraZeneca thinks it can minimize disruption to its clinical trials without compromising the safety of patients enrolled in its studies.

The wording of AstraZeneca’s statement suggests earlier-phase assets could be materially delayed, though, and the Big Pharma accepts the risk of disruption remains. Elsewhere in its first-quarter results, AstraZeneca told investors it expects the pandemic “to have the effect of heightening many of the risks” described in its annual report, “such as those relating to the delivery of the pipeline or launch of new medicines.”

Even so, AstraZeneca’s statement provides further evidence that drug developers are finding ways to keep studying drugs in humans despite COVID-19 and associated restrictions. Yesterday, Pfizer said it has recently restarted patient enrollment across its portfolio of clinical trials and begun kicking off new studies.

AstraZeneca shared details of the effect of COVID-19 on its drug development timelines alongside an update (PDF) on its pipeline. 

In the update, AstraZeneca said it has stopped development of MEDI3902, a bispecific antibody against PcrV and Psl, in the prevention of nosocomial Pseudomonas aeruginosa pneumonia. AstraZeneca took the action after getting a look at data from a phase 2 trial that finished late last year. Analysts at Jefferies tipped the drug to achieve peak sales of $500 million but only gave it a 15% chance of success.