Roche Quietly Pulls Two Phase II COVID-19 Studies in Q1
21 Apr 2021
AntibodyBiosimilarEmergency Use AuthorizationFinancial StatementAcquisition
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Roche has culled two more Phase II COVID-19 programs. The Swiss pharma giant quietly announced the cuts this morning in a breakdown of its first quarterly financial report. Roche said it removed a monoclonal antibody licensed from Amgen, as well as an IL-22 inhibitor, both of which were being assessed against COVID-19-related pneumonia.
Roche pulled a mid-stage study of its monoclonal antibody astegolimab (RG6149), which it had previously licensed from Amgen. The drug binds IL-33 to ST2. This is the second Phase II stud with astegolimab the company has terminated. Earlier this year, Roche canceled a mid-stage study of the asset in asthma.
Roche also terminated a Phase II study with RG7880 (efmarodocokin alfa) in COVID-19. Like astegolimab, Roche hoped efmarodocokin alfaalfa, which binds to IL-22, would be effective in preventing disease worsening of COVID-19-related pneumonia.
In its quarterly report, Roche did not provide additional details of why those two programs were pulled.
Despite the failures of those COVID assets, Roche did make headway against the global pandemic during the first three months of the year, particularly in its diagnostics division. Roche said its SARS-CoV-2 Rapid Antigen Test Nasal, which can quickly identify people with the highest risk to be infectious, received CE mark and special approvals for self-testing in several European countries. Also, Roche said its research-use cobas SARS-CoV-2 Variant Set 1 Test was launched in the quarter to help monitor coronavirus mutations across the globe.
Also in the first quarter, Roche boosted its diagnostics business with the $1.8 billion acquisition of GenMark Diagnostics, one of the first companies to receive Emergency Use Authorization from the U.S. Food and Drug Administration for its ePlex SARS-CoV-2 Test. That test will complement Roche’s own COVID-19 tests, including the Elecsys IL-6 test, which measures levels of IL-6 (interleukin-6), as well as its Elecsys Anti-SARS-CoV-2 antibody test.
On the therapeutics side, Roche highlighted its partnership with Regeneron. The company said the antibody combination of casirivimab/imdevimab is now benefitting patients in an increasing number of countries, incl. the United States, Germany, Italy, France and Switzerland. The antibody combination continues to demonstrate positive clinical results. In Phase III studies in the prevention of COVID-19, the casirivimab/imdevimab cocktail reduced symptomatic infections by 81% and reduced hospitalization or death by 70%.
Roche said it will continued to ramp-up of production capacity for COVID-19-related diagnostics and medicines.
“In 2021, Roche remains strongly committed to the fight against COVID-19. The uptake of our recently introduced diagnostic tests and medicines remains strong, while we continue to see the expected impact from biosimilars on sales of our established medicines,” Roche Chief Executive Officer Severin Schwan said in a statement.
In addition to the two COVID-19 programs, Roche also said it pulled a Phase III cancer study with Tecentriq, as well as two asthma programs and two oncology programs, all in Phase I testing.
Earlier this year, Roche announced the termination of other programs in its pipeline. In addition to astegolimab in asthma, Roche also canceled multiple mid- and late-stage programs in oncology, ulcerative colitis and autism spectrum disorder.
While Roche may have pulled some studies with Tecentriq this quarter, Roche did see its checkpoint inhibitor hit the mark as a potential treatment for early-stage lung cancer. The company also posted positive results for faricimab in ophthalmology.
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