Sponsors Begin to Settle on Trial Adjustments During Pandemic
While some sponsors are pulling back on enrollment and site activation, others are expressing confidence that they can continue their trial activities with adjustments to avoid the risk of COVID-19 exposure.
Akero Therapeutics still hopes to report topline data from its fatty liver disease trial in the second quarter but is unsure how long it will take to collect biopsies from the remaining half of its 50-patient cohort. Biopsies of the remaining 25 patients could be conducted in locations less affected by COVID-19, the company says. Akero will delay the portion of the AKR-001 trial that involves patients with compensated cirrhosis.
Alligator Bioscience reports it will pause recruitment for its phase 1 trials of metastatic cancer drugs ATOR-1015 and ATOR-1017.
Amgen is optimistic about its pipeline, especially its trial for lung cancer drug AMG 510, which is currently in phase 2 and fully enrolled. Phase 3 trials for its tezepelumab asthma drug and the omecamtiv mecarbil heart failure study also are fully enrolled. The company says it does not anticipate any “significant delays” for these trials.
AM-Pharma says it will go ahead with its phase 3 trial of recAP, an anti-inflammatory enzyme, although it will push initiation from this summer to the fall. The company says the severity of the condition recAP is intended to treat, sepsis-associated acute kidney injury, contributed to the decision to stick to the original trial timeline as closely as possible.
AVRBIO is continuing patient identification activities for its trials in the U.S., Canada and Australia. The Boston-based gene therapy company is pursuing a phase 2 global trial of its drug AVR-RD-01 to treat Fabry disease, which already has dosed four patients, and a phase 1 investigator-led trial of the same drug that is fully enrolled. Other trials include phase1/2 studies of treatments for cystinosis and Gaucher disease.
CRISPR Therapeutics has halted dosing of patients in its trials of products to treat severe hemoglobinopathies and immuno-oncology due to expected shortages of hospital beds and other resources in locations affected by COVID-19. The company, as of its last report, was still enrolling patients in an early safety trial started last summer.
Dynavax Technologies reports its HEPLISAV-B postmarketing observational studies are continuing in California. Its dialysis trial of the same drug is continuing to enroll, the company says, because the state classifies dialysis as essential medical treatment. Interim analysis data should be reported later this month.
Eiger Biopharmaceuticals is switching to remote patient visits, local lab testing and home delivery of investigational drugs for its rare and ultra-rare disease trials in 20 countries, including its phase 3 D-LIVR trial. The company expects enrollment for the trial will not be completed until 2021. Other trial adjustments Eiger is making include extending screening windows and delaying remaining site activations.
Genfit is going ahead with plans to unblind data from its phase 3 nonalcoholic steatohepatitis (NASH) treatment as soon as the FDA has provided feedback on the study. The company has paused its phase 1 trials of its NASH drug elafibranor and stopped enrollment in its phase 2 liver fat study. A phase 2 NASH trial and a phase 3 trial on primary biliary cholangitis are on hold.
GlaxoSmithKline has issued guidance on continuing non-COVID-19 studies during the pandemic, including recommending that investigators ensure the appropriate monitoring and follow-up of currently enrolled subjects before considering recruitment of new patients. Studies involving healthy volunteers should not be initiated, and the company will delay trials that have not reached the point of first-patient-first-visit.
Mithra will continue its phase 3 studies of Donesta in 2,200 menopausal women in North America, South America, Europe and Russia but will pause recruitment for some sites.
Moderna has halted new enrollment and site initiation for its current rare disease trials. The company is collaborating with the NIH on trials of a COVID-19 vaccine, mRNA-1273.
Reata Pharmaceuticals reports it will stop its trials involving patients with pulmonary arterial hypertension and pause enrollment in the phase 3 FALCON study of bardoxolone in patients with autosomal dominant polycystic kidney disease, but will continue the second year of its phase 3 bardoxolone trial in patients with chronic kidney disease caused by Alport syndrome.
The UK’s Medicines and Healthcare products Regulatory Agency says all sponsors of phase 1 trials under its jurisdiction should have conducted an assessment of risk to trial participants by now and made the decision to pause, terminate or continue trials based on public and patient safety.