COVID-19 Continues to Impact Enrollment and Recruitment of Clinical Trial Patients
As COVID-19 has swept across the world, companies have had to make significant adjustments to the way business is conducted in a global economy. It has impacted all types of operations, including clinical trials.
Over the past several weeks, pharma companies, clinical research organizations, universities and more have announced the suspension or delay in enrollment of some clinical trials due to concerns of the spread of the pandemic. Some trials that have been underway are continuing. CytomX President and Chief Executive Officer Sean McCarthy told the San Francisco Business Times that the deprioritization of clinical trials during the pandemic as resources are needed to treat COVID-19 patients is “entirely appropriate.”
As the Times noted, Bay Area-based CytomX has paused new patient enrollment, as well as the activation of new clinical sites in a Phase I/II study of CX-2009, a CD166-targeting Probody drug conjugate, for various types of cancer. CytomX also made the decision to terminate the PROCLAIM-CX-072-002 study evaluating the anti-PD-L1 Probody CX-072 in combination with Bristol Myers Squibb’s Yervoy (ipilimumab) in melanoma.
CytomX is certainly not the only company pausing trials. The Times reported multiple Bay Area-based companies have halted trials during this time due to the pandemic, including Kezar Life Sciences, Nektar Therapeutics and Eiger BioPharmaceuticals have also had to adjust their clinical plans.
Last week, South San Francisco-based Denali Therapeutics said ongoing enrollment of additional healthy volunteers and patients at higher doses in its Phase I and Phase Ib trials assessing the company’s LRRK2 program for Parkinson’s disease have been paused. Likewise, the company paused recruitment of additional patients in its ETV:IDS program for Hunter Syndrome. It has also paused a program in ALS. CEO Ryan Watts said the company’s top priority is to “ensure the health and safety of our employees, community, partners and clinical trial participants.”
“We are very pleased with our productivity under the circumstances and we continue to generate and analyze new data across our pipeline. We are, however, experiencing enrollment delays in some of our clinical-stage programs, and consequently, we are actively working to maintain clinical operations to minimize any disruption,” Watts said in a statement.
San Diego-based Otonomy Inc. said this morning it has temporarily paused new patient enrollment in its OTO-413 Phase I/II Clinical Trial in Hearing Loss. The company has already completed several dose cohorts but paused due to safety concerns. The company did report that enrollment in its Phase III trial in Ménière’s Disease will continue and be managed on a “country-by-country and site-by-site basis according to local conditions.” Otonomy said they believe there is minimal impact of COVID-19 on the integrity of data being collected for enrolled patients because patients report their vertigo episodes via a daily telephone diary.
Cambridge, Mass.-based Trillium Therapeutics said it is addressing COVID-19 derived challenges on a patient-by-patient basis. Trillium said all active patients on the TTI-621 and TTI-622 clinical studies are continuing treatment, and the company expects that these patients will continue treatment in the study. On March 24 and April 1, Trillium enrolled the first patient in the 1.4 mg/kg cohort of the TTI-621-01 study and the first patient in the 8.0 mg/kg cohort of the TTI-622-01 study, respectively. Going forward, Trillium expects that enrollment in the TTI-621 and TTI-622 clinical studies will slow down or potentially pause as many clinical sites are putting enrollment of new patients on hold.
“Trillium is working hard to ensure operational continuity to serve patients whose lives are affected by severe diseases while protecting the health of our employees,” Jan Skvarka, president and CEO of Trillium said in a statement.
While Moderna, Inc. has dosed its first patient in a Phase I trial assessing the potential of a mRNA vaccine candidate against COVID-19, the Cambridge, Mass.-based company has paused enrollment in its Phase I rare disease clinical trials for Methylmalonic Acidemia and Propionic Acidemia. The company has also de-escalated is pediatric respiratory vaccine study due to the virus. These decisions will be re-evaluated on an ongoing basis as the COVID-19 situation evolves, Moderna said. The company also decided to suspend new enrollment of participants in the on-going hMPV/PIV3 study, which had been actively enrolling seropositive pediatric participants.
“The COVID-19 pandemic has created unprecedented challenges and we are committed to ensuring the health and safety of all participants in our and our partners’ clinical trials, our clinical trial site teams, vendors and our employees. Moderna’s primary focus is on the safety of all involved and the continued conduct of our clinical programs as we navigate the pandemic together,” Moderna CEO Stephane Bancel said in a statement.