A Phase III investigator-led trial studying Eiger BioPharmaceuticals’ hepatitis D virus (HDV) asset peginterferon lambda (IFN-lambda) in Covid-19 is building towards initiation, said primary investigator Dr Jordan Feld, associate professor of medicine, University of Toronto, Canada. However, timelines are dependent on how quickly the ongoing trial fundraise of at least $10m would be hit, he said.

The Phase III would investigate IFN-lambda in so-called “ambulatory patients,” who are outpatients with mild-to-moderate disease. Full Phase II data in 60 ambulatory patients will be published in February in the journal Lancet Respiratory Medicine, Feld said, adding the paper was accepted in December.

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The single-site Phase II ILIAD trial has two cohorts recruiting ambulatory and hospitalised patients. Feld noted that the hospitalised cohort is recruiting slower than expected, with only about a quarter enrolled out of a planned 200 participants so far. The trial is currently recruiting in Toronto General Hospital, with the trial expanding to Brazil soon. Quicker expansion to additional sites is obstructed by competition with industry-sponsored trials, Feld said. And in its one recruitment site, it is competing with several other ongoing trials investigating other assets by other companies for the same patients, he added.

ILIAD’s ClinicalTrials.gov listing, last updated on 13 May, shows it has a 140-patient target in both cohorts. The hospitalised cohort was increased to 200 participants on the heels of a change in primary endpoint, Feld said, but did not comment on when these changes were made. The cohort initially had a primary endpoint of time to viral negativity, which was changed to clinical improvement based on an ordinal scale, due to the latter being more clinically relevant, he explained.

ILIAD has a history of recruiting patients slower than projected, with this news service reporting on 16 July that its ambulatory cohort was having recruitment delays due to such patients being challenging to find. On 18 September, this news service reported ILIAD’s hospitalised patient cohort had yet to enrol. The trial was first listed on ClinicalTrials.gov on 20 April. IFN-lambda is one of Eiger’s main assets and is Phase III-ready as a monotherapy in HDV. The Eiger-run, 150-patient HDV trial is anticipated to start in 2H21, according to a 7 January media release.

Phase III ambulatory trial may recruit between 300–700 patients

The Phase III IFN-lambda trial design in ambulatory patients will depend on how much funding will be raised, Feld said. One trial design has a target of 300 patients, while another protocol has a 600–700 patient target, he noted. Both designs are event-driven, with a primary endpoint looking at how many patients in the treatment and placebo arms are hospitalised, he added. Phase III’s primary endpoint is more clinically relevant than ILIAD, with the latter primarily investigating viral load decline in ambulatory patients, he explained.

Phase III will start as soon as funds are raised, Feld said, declining to add additional details such as which funding bodies he and his team are in communications with. Eiger is unable to fund the trial by itself owing to it being a relatively small pharmaceutical company, he noted, but added that Eiger is working closely behind the scenes to help kickstart the Phase III. Eiger has a $345.8m market cap. Eiger’s lead asset is lonafarnib in HDV, with the ongoing 400-patient Phase III D-LIVR trial’s recruitment completion planned this year, as per the 7 January release. Eiger did not respond to a comment request.

In Covid-19, IFN-lambda is administered as a single subcutaneous dose. It works to stimulate the immune system for it to be able to protect the host during a viral infection. On 15 October, an Eiger media release stated ILIAD’s 60-patient ambulatory patient cohort had positive results. Patients in the treatment arm were 4.1-fold more likely to clear the virus at day seven versus patients receiving placebo (p=0.029). In patient with a baseline viral load of >6log copies/mL, 15 out of 19 IFN-lambda patients cleared the virus at day seven, versus 6 out of 16 in the placebo arm (p=0.013).

Reynald Castaneda is Associate Editor for Clinical Trials Arena parent company GlobalData’s investigative journalism team. A version of this article originally appeared on the Insights module of GlobalData’s Pharmaceutical Intelligence Center. To access more articles like this, visit GlobalData.