ViewPoints: Impact of COVID-19 on clinical trial enrolment comes into view

We recently asked 98 of our subscribers to evaluate their concerns about the potential impact of the COVID-19 pandemic on day-to-day running of the pharmaceutical industry; the risk of compromised or delayed clinical studies featured prominently. More here

On Monday, Galapagos and Eli Lilly became the most notable drug companies to date to confirm that enrolment in certain clinical studies will be paused as a result of the outbreak in order to protect patient safety.

What’s new?

Galapagos will pause enrolment into Phase II and III studies evaluating its JAK inhibitor filgotinib across a number of indications including Crohn’s disease and psoriatic arthritis (both Phase III) and uveitis (Phase II). On a more positive note, a Phase III study in ulcerative colitis is fully enrolled and results are expected in the second quarter of 2020, while Galapagos anticipates that a planned Phase III study in ankylosing spondylitis will start later in the year.

Filgotinib is being co-developed with Gilead Sciences, which as part of a broader, 10-year R&D collaboration paid the Belgian biotech company just shy of $4 billion up front last year. Galapagos CEO Onno van de Stolpe noted that a strong balance sheet will play a key role in allowing the company to “weather the storm.”

In a statement released on Monday Eli Lilly said the COVID-19 pandemic has “substantially impacted the global healthcare delivery system, including the conduct of clinical trials.” The company says it will delay most new study starts and pause enrolment in most ongoing studies, blaming the severe burden on healthcare systems caused by the outbreak. Studies which are already fully enrolled will continue.

The bigger picture

Eli Lilly has three experimental drugs which are being followed particularly closely by investors; the diabetes treatment tirzepatide, the cancer therapy selpercatinib and the autoimmune treatment mirikizumab.

The five most advanced Phase III studies evaluating tirzepatide, including those which Eli Lilly presumably anticipate using to support registration with regulatory authorities, are fully recruited with initial data expected in late 2020. However, a number of other pivotal-stage studies, including a cardiovascular outcomes trial and one testing tirzepatide for obesity, are either recruiting or have yet to start recruiting patients.

Selpercatinib has already been submitted to regulators for RET positive non-small cell lung cancer, thyroid cancer and medullary thyroid cancer, though a number of planned follow-on studies will now be delayed.  

In the case of mirikizumab, pivotal-stage studies in psoriasis patients are fully enrolled (positive data from two studies, OASIS-1 and OASIS-2, are expected this year are required to support filing) though a longer term study evaluating its use as a maintenance treatment for psoriasis is still recruiting patients. Furthermore, Phase III studies in ulcerative colitis and Crohn’s disease are either planned (and yet to recruit patients) or are recruiting patients currently and are therefore likely to be delayed.

Another drug forecast to be one of Eli Lilly’s key sales growth is the breast cancer treatment Verzenio, which is being in studied across various lines of therapy and in other tumour types. At the tie of publication, Eli Lilly had not responded to our request for further information about clinical studies of this particular drug.  

Final thoughts

It remains to be seen how transparent individual pharma companies are about the impact of the COVID-19 outbreak on clinical studies. In a note to investors published last week analysts at Morgan Stanley wrote that “existing drugs could face fewer new competitive threats,” but those that are “dependent upon new indications may benefit less from anticipated future growth drivers.”  

Feedback from our recent survey of 98 industry professionals revealed that over 50% of respondents believe the risk posed to clinical studies from the COVID-19 outbreak represents a potentially greater than moderate impact on completion, delay and/or data integrity.  

A fifth of respondents said they are ‘very’ concerned about the potential impact on clinical study timelines.

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