Analysts at RBC Capital Markets are warning that a host of biopharmas could see their ongoing phase 3 trials hit by the novel coronavirus, as early-stage trials are particularly under threat.
The analysts said that, in general, while the current coronavirus situation “appears relatively manageable” for its covered companies, “we do see potential for an escalating negative impact to some degree on uptake but greater extent on clinical trials.”
Specifically, they see the coronavirus fears hitting enrollment into clinical trials, something “which could slow drug development across the board, and we view this as an important, albeit transient, risk to the sector.”
Some of the most susceptible studies will be phase 1 tests, which rely typically on healthy volunteers in medical or hospital settings; it’s likely they will not want to travel to these sites amid an outbreak, the analysts note, adding there will also likely be “resource constraints stemming from coronavirus” for trials.
“Clinical conduct for ongoing studies is also likely to be negatively impacted, as mobility precautions (particularly for studies in sites in highly-affected countries like China or Italy) or illness itself could reduce patient compliance and follow-up,” it added.
Drilling down into some of its covered companies, “we note that the several key studies from our covered companies that include sites in Italy, China, and/or Korea,” which have all been hit hard by the virus.
This includes Gilead Sciences and partner Galapagos’ phase 3 test of GLPG1690 in idiopathic pulmonary fibrosis and a midstage study in systemic sclerosis (SSc), as well as Intercept’s late-stage REGENERATE trial in nonalcoholic steatohepatitis and Corbus’ phase 3 of lenabasum in SSc and dermatomyositis.
It could, however, work out as a positive for Enanta Pharmaceuticals, RBC reckons, given it is conducting a study in community-acquired respiratory syncytial virus patients, which can cause respiratory issues.
“Overall, the coronavirus could make ongoing clinical studies more challenging to enroll and interpret,” it warned, though it added the biopharmas have not yet seen any impact on trials.