A drug company called Ashvattha Therapeutics is working on a new drug candidate for long Covid, OP-101. Link: Ashvattha previews plans for long Covid trial in mid-2023 Key takeaways: OP-101 was originally developed for neurodegenerative disease They're discussing their plans with the FDA so nothing is set in stone. Potentially phase IIa trial with 300-400 participants. Patients will have LC and elevated C-Reactive protein. They hope they can get approval after just one trial (I'm skeptical) It's supposed to reduce inflammation by acting on macrophages and microglia Outcome measures might be lung function, fatigue scores, and cognitive testing. The fact that OP-101 affects microglia connects with Jared Younger's research and the neuroinflammation hypothesis, which I'm a fan of.
My first thought was, 'yeah, right, it didn't work out for Covid-19 and so now they have a snake oil drug looking for a disease'. But actually their Phase IIA trial in acute Covid-19 was pretty decent, and it did indicate that the drug might help clinical outcomes. Dendrimer nanotherapy for severe COVID-19 attenuates inflammation and neurological injury markers and improves outcomes in a phase2a clinical trial The sample size was small and I'm sure there were complicating factors, such as random differences in when patients were given steroids, and with their comorbidities. But even so, the results still looked interesting. Here for example, are levels of markers of neurological injury (red dots are the patients who died). I thought this was interesting about the drug potentially being useful in periperhal neuropathy. I can't recall if levels of NfL have been looked at in ME/CFS, probably they have and nothing was found. The trial for Long Covid sounds as though it isn't really targeting the ME/CFS sort of Long Covid, with its selection of patients with high CRP and the primary outcome of lung function.
Thanks for the detailed analysis. You may be right that they're targeting long Haulers without ME-like symptoms.
