Home » Sponsors, Sites Continue to Deal With Trial Disruptions
Sponsors, Sites Continue to Deal With Trial Disruptions
April 20, 2020
Pharma companies and CROs continue to announce temporary suspensions of patient recruitment during the COVID-19 pandemic, but some companies are pivoting themselves and re-positioning their efforts toward studying possible treatments for the virus:
- Restrictions to control the spread of COVID-19 in in Singapore has led Aslan Pharmaceuticals to pause recruitment of new patients into its study of ASLAN004, an anti-IL-13R?1 antibody and potential treatment for moderate to severe atopic dermatitis. The Singapore-based biotech says it is still on track to deliver interim results of the trial’s three dose cohorts in the third quarter.
- San Francisco, Calif.-biopharma company CytomX has halted enrollment of new patients and paused activation of new sites for its phase 1/2 study of cancer investigational drug CX-2009. CytomX also terminated its PROCLAIM-CX-072-002 melanoma study in response to the COVID-19 pandemic. The study planned to examine a combined therapeutic regimen consisting of anti-PD-L1 Probody CX-072 plus Bristol Myers Squibb’s ipilimumab.
- CRO company IQVIA has initiated a matchmaking trial service, which is designed to accelerate vaccine development and treatment of COVID-19.
- Moderna has paused enrollment for its phase 1 trials of methylmalonic acidemia and propionic acidemia. The Cambridge, Mass.-based company has also de-escalated its pediatric respiratory vaccine study and has suspended enrollment of new seropositive pediatric patients for the ongoing human metapneumovirus/parainfluenza phase 3 study. Moderna has funneled most of its energy into a phase 1 clinical trial of an mRNA vaccine candidate against COVID-19. The company’s COVID-19 vaccine trial has recently dosed its first patient.
- Outlook Therapeutics announced that the recruitment for its NORSE 2 ongoing trial of bevacizumab-vikg, an ophthalmic formulation of bevacizumab, has slowed because of the global health crisis. Additional safety protocols to reduce transmission of the virus have resulted in the temporary closure of some trial sites. The final enrollment could be delayed by one to three months, according to Outlook estimates. NORSE 2 will continue to screen and treat participating patients.
- Parexel has announced that it has temporarily stopped screening new patients and health participants in UK clinical trials because of the restrictions posed by COVID-19.
Standard Operating Procedures for Risk-Based Monitoring of Clinical Trials
Learn More Here