Today at the PolyBio Spring Symposium, Dr. Michael Peluso presented results from the outSMART-LC trial, which tested the monoclonal antibody AER002 in Long COVID patients. Unfortunately, the study did not show significant symptom improvement.
Dr. Peluso outlined several reasons why the treatment may not have worked:
• The drug may not have been potent enough or properly dosed
• A single dose may have been insufficient
• The mAb may not have neutralized mutated viral forms
• No antivirals or interferons were paired with it
• Participants may not have had confirmed viral persistence
• No biomarker was used to measure therapeutic response
• Some patients may have had autoimmune drivers instead of viral ones
These findings reinforce a crucial truth: mono-therapy is not enough.
What We Need Now:
In his forward-looking recommendations, Dr. Peluso called for a new generation of trials, including:
• Biomarker-guided enrolment under a new VIPER program
• Use of modern monoclonals
• Combination trials with antivirals, monoclonals, and possibly interferons
• Exploration of monoclonals + therapeutic vaccines (as in HIV research)
We strongly support this direction.
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Encouraging News on Pemgarda
In parallel, we’ve received positive news from Invivyd, the manufacturer of Pemgarda:
They’ve confirmed they are willing to bring Pemgarda to Canada—but are waiting on regulatory clarity from Health Canada.
This means the holdup now appears to be with Health Canada.
We’ve now formally reached out to Health Canada requesting clarity on whether they will adopt a more flexible immune-bridging pathway, as the U.S. FDA has done, to allow Pemgarda access.
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Encouraging Wastewater & Infection Trends—But Caution Still Warranted
The latest wastewater levels indicate that COVID-19 infections in Canada are currently at their lowest point in years. This is encouraging—and a hopeful sign that transmission is slowing for now.
However, we must remain cautious. Throughout the pandemic, April and May have often marked seasonal lows, followed by summer or fall resurgences. This pattern has repeated itself over multiple years.
Low levels today do not eliminate risk tomorrow—especially for the immunocompromised and those living with Long COVID, who remain vulnerable even when overall transmission appears low.
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Our Work Continues
We’re now at 265 signatures. While we haven’t yet received replies from the first three journalists we contacted, we remain committed to making noise. Canada must not be left behind as the next generation of Long COVID trials begins.
Long COVID patients and immunocompromised individuals deserve access, protection, and research that reflects the urgency of their needs.
Thank you for continuing to stand with us.
Let’s keep pushing.
In solidarity,
Rowan
#MAbsForCanadaNOW | #ProtectImmunocompromised |#LongCOVID | #COVID19IsNotOver
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