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August 13, 2021updated 19 Feb 2022 1:22pm

Trial of AbbVie’s NASH drug against severe Covid-19 enrols 25% of patients after a year

The investigator-led trial has so far recruited 45 out of 183 patients despite enrolment opening in July last year.

By Reynald Castañeda

An investigator-led Phase II trial investigating AbbVie’s nonalcoholic steatohepatitis (NASH) asset cenicriviroc (CVC) in hospitalised Covid-19 patients has so far recruited 45 patients of its 183-participant target, said principal investigator Dr Frank Tacke, professor of medicine, Department of Hepatology and Gastroenterology at the Charité Universitätsmedizin Berlin, Germany. The trial started recruiting in July 2020.

Interim analysis based on the placebo-controlled trial’s first 30 patients is complete, with the manuscript being drafted for publication in a scientific journal soon, Tacke added. While he declined to elaborate on details, CVC has some positive efficacy signals but the small trial size makes definitive conclusions premature, he noted. The Phase II’s primary endpoint is patients being discharged from hospital at day 15.

CVC trial had a late start

Last August, the Germany-based trial faced recruitment delays due to the declining numbers of hospitalised Covid-19 patients. Another wave of community infections starting in autumn 2020 could help with recruitment, Tacke told this news service last August.

Germany subsequently has had two waves of daily new confirmed cases in the past 12 months: the first peaking on 23 December with 25,757 cases, and the second on 25 April with 25,595 cases. But Tacke said there haven’t been many patients who are sick enough to be hospitalised to be recruited in the trial. The trial is currently recruiting from a single site in Berlin.

Weekly new hospital admissions in Germany peaked on 20 December 2020 with 7,907 patients and on 18 April with 5,934 patients. The Phase II study is investigating CVC in hospitalised Covid-19 patients who at the very least do not require supplemental oxygen. As of 8 August, some 61% of people in Germany have received at least a single dose of a Covid-19 vaccine, with 54% counted as fully vaccinated, according to Our World in Data.

CVC dropped from critically ill Covid trial

CVC is in two other Covid-19 trials. On 28 April, the Phase II I-SPY COVID basket trial dropped CVC based on a low likelihood of success. I-SPY COVID recruited patients who were critically ill such as those receiving high-flow oxygen or mechanical ventilation. I-SPY COVID is run by the Quantum Leap Healthcare Collaborative based in San Francisco.

The second trial is the National Institutes of Health-run Phase III ACTIV-1 IM basket trial recruiting moderate-to-severely ill Covid-19 patients. CVC data is yet to be reported. ACTIV-1 IM is also investigating two other immune modulators: Johnson & Johnson’s Remicade (infliximab) and Bristol Myers Squibb’s Orencia (abatacept). CVC is designed to block chemokine receptors CCR2 and CCR5, and so would have an anti-inflammatory effect in Covid-19.

CVC terminated in NASH

In NASH, CVC’s Phase III AURORA trial was terminated early due to lack of efficacy based on results of the trial’s Part I portion, according to an 8 January ClinicalTrials.gov update. Triggered by the build-up of fat in the liver, NASH is a type of chronic liver disease that can lead to cirrhosis. Despite several pharmaceutical companies pursuing NASH, many potential drugs have so far delivered unsatisfactory late-phase data or regulatory pushback. There are no drugs so far approved for NASH.

CVC was previously owned by Allergan until it was acquired by AbbVie in May 2020. AbbVie, which did not respond to a comment request, has a $201.56bn market cap.

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