Home » Sponsors Report Trial Adjustments During Pandemic
Sponsors Report Trial Adjustments During Pandemic
A number of research efforts reported disruptions last week to their trial efforts due to the COVID-19 pandemic:
- San Francisco, Calif.-biotech firm Denali Therapeutics has paused recruitment of additional patients at higher doses in two trials for Parkinson’s disease. It also halted recruitment for a Hunter syndrome trial due to the national health emergency. The company said “considerable uncertainty remains” about how other trials will be affected going forward.
- Cancer Research UK has had to cut $54.8 million (£44 million) of research funding in response to the outbreak. The oncology research charity predicts a drop in income of up to 25 percent in 2020. It added that it has had to furlough at least 40 percent of its workforce.
- Cell-based medicine developer MaxCyte said that its life sciences business may be impacted by the virus, noting that some clinical sites could be restricted solely to COVID-19 research. It also said that its commissioned clinical trials may face delays.
- Immuno-oncology company Trillium Therapeutics expects new patient enrollment to slow down — potentially to a halt — for two dose-escalation studies. The studies target CD47, a “do not eat” protein cancer cells can use to evade the body’s immune system.
- Protease inhibitor developer KalVista Pharmaceuticals’ phase 2 trial for hereditary angioedema is likely to experience a delay in reporting of data. The company said that it expects to have results to present in the second half of 2020.
- Certain components of Swedish biotech company Cantargia’s development program for a systemic sclerosis and myocarditis antibody have been affected, including biochemistry and production, forcing it to move the start date of the phase 1 trial to early 2022.
- Inventiva has suspended the recruitment and screening of new patients in its phase 2 trial of lanifibranor for treating non-alcoholic fatty liver disease for all of its University of Florida sites.
- Neurotology therapeutic developer Otonomy has had three trials impacted by the pandemic. Enrollment for its phase 3 trial for Ménière’s disease and phase 1/2 tinnitus trial is being handled on a site-by-site basis according to local conditions, while its phase 1/2 trial for hearing loss has seen enrollment temporarily paused.
Standard Operating Procedures for Risk-Based Monitoring of Clinical Trials
Learn More Here