Gilead/Galapagos, Intercept and Corbus trials could be hit by coronavirus spread: analyst

Coronavirus Subway Train
Phase 1 tests could be the hardest hit. (David Paul Morris/Bloomberg via Getty Images)

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.”

Webinar

Digitize remote site monitoring with Box

Box will discuss how your life sciences organization can continue to propel therapies & devices through the value chain with faster and even more secure site monitoring and auditing.

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.

Suggested Articles

Study data from Medtronic showed more patients reported improvements in their chronic back pain after treatments with the devicemaker’s tiny implant.

The biotech behind AstraZeneca and the University of Oxford’s late-stage pandemic vaccine has hired Margaret (Meg) Marshall, M.D., as its new CMO.

On the heels of a merger and $60 million private offering, Compass is looking to go public. It filed to raise up to $50 million in its Nasdaq IPO.