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Pharmaceuticals

Reactions: Long COVID R&D

October 20, 2024 | A version of this story appeared in Volume 102, Issue 33

 

Letters to the editor

Long COVID R&D

I am a severe myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) patient. I have some information to impart about ME/CFS and drug development and how it can aid long COVID R&D (C&EN, Sept. 30, 2024, page 24).

In brief, 11 microRNAs can identify people with ME/CFS and long COVID and potentially identify drug responders for drugs like Ampligen. We need to get drug companies to adopt these microRNAs to make clinical trials successful.

Long COVID is not a single disease. It is molecularly a disease with six subsets, as we saw in Alain Moreau’s presentation on the second day of the National Institutes of Health (NIH) ME/CFS conference in December 2023. More than half are related to ME/CFS, according to Moreau. Trying to develop a drug for long COVID as though it were a single disease entity loses the signal and causes the positive drug response to get lost.

Drug companies need objective entry and end points for successful clinical trials.

In 2012, an advisory committee to the US Food and Drug Administration mostly voted not to endorse Ampligen, citing insufficient efficacy data. The FDA noted a lack of diagnostic tests for ME/CFS during the committee’s meeting, and the agency chose not to approve the drug. On the other hand, the NIH isn’t currently funding further development of a nanoelectronic device invented by Rahim Esfandyarpour and Ron W. Davis that distinguished ME/CFS patients from people without the disease in a 40-person study. The device uses salt to stress out ME/CFS cells to mimic the cardinal symptom of ME/CFS, normally provoked by the 2-day cardiopulmonary exercise test (2-day CPET), an objective marker for ME/CFS.

In 2024, ME/CFS has the 2-day CPET and four diagnostic blood tests in development that Aim ImmunoTech and other drug companies could be taking advantage of for long COVID R&D.

The leading ME/CFS potential diagnostic blood test is 11 microRNAs from the lab of Moreau. If Aim ImmunoTech and other drug companies want to succeed at long COVID R&D, I suggest the following:

adopting the 2-day CPET in some of their studies where it can be used

adopting 11 microRNAs to cluster and identify patients and identify drug responders

calling for policy at the NIH to set aside funding for an ME/CFS diagnostic blood test, get Esfandyarpour’s nanoneedle invention back in play, and commercialize the 11 microRNAs ASAP

Andrea Martell
Gloucester, Ontario

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