Alexion plans phase 2 study of Soliris in COVID-19 in coming days: report
The race for a COVID-19 therapeutic has attracted many of the biggest names in biopharma, and now Alexion is getting ready to place a bet on its own Soliris, GlobalData reports.
The company, which markets several rare disease medicines, plans to start a phase 2 study of Soliris in COVID-19 in the “next few days,” the group reports. The study would follow a 10-patient proof-of-concept trial in which “patients improved in general,” a source told GlobalData pharmaceuticals writer Reynald Castañeda.
The drugmaker has already said it’s looking into Soliris and COVID-19. In a March 24 statement, the company unveiled that it had reached out to federal officials in early February to discuss Soliris as a possible treatment. Alexion believed there was “preclinical scientific rationale” supporting the drug’s use in patients with severe pneumonia or acute respiratory distress syndrome. On Tuesday, a spokeswoman said the discussions are “ongoing.”
In the March statement, Alexion said it had provided Soliris as an “experimental emergency treatment for a small number of patients with COVID-19 infection and severe pneumonia.” The company processed the requests on a case-by-case basis.
Soliris is already FDA-approved to treat rare diseases paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome, among other indications.
A search of clinicaltrials.gov shows one study of Soliris in COVID-19. The trial is looking at mortality, time in intensive care and time on a ventilator for patients who receive the medicine. The study requires an FDA investigational new drug application for each patient, plus an authorization letter from Alexion.
“While this virus is the provocateur, it is often the patient’s own disproportionate immune response which deals the most devastating (and often fatal) damage,” the study summary says. “A specific part of the immune system, known as the complement, has been shown to cause such damage in other types of coronaviruses.”
The study is exploring whether inhibiting that response could improve outcomes while patients are given time to recover with other supportive care.
Elsewhere in the industry, Karyopharm on Tuesday unveiled plans to test Xpovio in COVID-19. The drug is already approved in multiple myeloma, but the company said it sees scientific rationale in testing the medicine against the novel coronavirus.
The latest efforts are among the many projects underway at biopharma companies to identify existing and new therapies that might help patients with COVID-19. The pandemic has made its way to almost every country, and the virus has infected more than 1.3 million people. As of Tuesday, more than 76,000 people worldwide had died.