PaxMedica Plans to Initiate Phase 1B Study for PAX-101 (Suramin) in Patients with Long COVID-19 Syndrome

Sly Saint

Sly Saint

Senior Member (Voting Rights)
Study has been approved by the South African Health Authority for individuals with documented COVID-19 infections who develop debilitating physical and neuropsychiatric symptoms that persist for more than 12 weeks after the viral infection has passed

- Enrollment is expected to commence in Q1 2022

TARRYTOWN, N.Y., Jan. 7, 2022 /PRNewswire/ -- PaxMedica, Inc. ("PaxMedica" or the "Company"), a biopharmaceutical company focused on developing medicines that help overcome the challenges of living with complex neurological conditions, today announced that it has received approval from the South African Health Products Regulatory Agency (SAHPRA) for its clinical trial application to study the effects of PAX-101 (suramin intravenous (IV) infusions) in patients with Long COVID-19 Syndrome (LCS), also known as post-acute sequelae of SARS-CoV-2 infection.

The study, PAX-LCS-101, will be a Phase 1B, prospective, randomized, placebo-controlled, double-blind, multiple-dose study. The study is expected to start enrolling patients in the first quarter of this year after obtaining South African National Ethics Committee approval.

LCS is a serious, multi-system illness that results in significant impairment of functioning in many individuals after acute infection with COVID-19. The diagnosis of LCS is challenging as there are no specific tests to establish the diagnosis. Although there are many definitions proposed in the medical literature, most researchers define LCS as a syndrome that includes a protracted course of various physical and neuropsychiatric symptoms that persist for 12 weeks or more without an alternative explanation. The study is expected to enroll patients with persistent signs and symptoms of LCS, after a previously documented infection with the COVID-19 virus. The symptoms of LCS in each patient can vary but often include fatigue, "brain fog", pain, headaches, shortness of breath, difficulty with concentration and attention, sleep disturbance, orthostasis and dizziness, and decreased functioning as well as many associated symptoms such as joint and muscle pain, depression and anxiety.
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LCS has been observed to closely resemble another post-acute infection disorder known as myalgic encephalomyelitis / chronic fatigue syndrome (ME/CFS). In both disorders, fatigue is a prominent symptom and many of the other observed symptoms overlap. Both conditions may result in an inability to work or perform normal activities and in extreme cases of ME/CFS, have been documented to last for years, resulting in those affected becoming home-, if not bed-bound. PaxMedica plans to study PAX-101 as a treatment for both LCS and ME/CFS.

"People who suffer from Long COVID Syndrome and ME/CFS have nearly identical physical symptoms and there may be a similarity in the underlying pathophysiology related to mitochondria and purinergic signaling. Using a purinergic antagonist, like suramin, may play an important role in addressing both of these syndromes," commented Robert Naviaux, MD, PhD and co-Director of the Mitochondrial and Metabolic Disease Center at the UCSD School of Medicine.

This clinical trial is planned to study the safety and tolerability, efficacy, and PK of two doses of suramin (5 mg/kg and 10 mg/kg) in adults, 18 years and older, with LCS.
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https://www.prnewswire.com/news-rel...ts-with-long-covid-19-syndrome-301456006.html

Discussion thread on Suramin:
Suramin as a possible treatment for Autism and ME CFS
 
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Truly ground breaking (or perhaps not) https://en.wikipedia.org/wiki/Suramin

"Suramin is a medication used to treat African sleeping sickness and river blindness. It is the treatment of choice for sleeping sickness without central nervous system involvement. It is given by injection into a vein.

Suramin causes a fair number of side effects.Common side effects include nausea, vomiting, diarrhea, headache, skin tingling, and weakness. Sore palms of the hands and soles of the feet, trouble seeing, fever, and abdominal pain may also occur. Severe side effects may include low blood pressure, decreased level of consciousness, kidney problems, and low blood cell levels. It is unclear if it is safe when breastfeeding.

Suramin was made at least as early as 1916. It is on the World Health Organization's List of Essential Medicines, the safest and most effective medicines needed in a health system. In the United States it can be acquired from the Centers for Disease Control (CDC). The cost of the medication for a course of treatment is about US$27. In regions of the world where the disease is common suramin is provided for free by the World Health Organization (WHO)."
 
CRG said:
Truly ground breaking (or perhaps not) https://en.wikipedia.org/wiki/Suramin

"Suramin is a medication used to treat African sleeping sickness and river blindness. It is the treatment of choice for sleeping sickness without central nervous system involvement. It is given by injection into a vein.

Suramin causes a fair number of side effects.Common side effects include nausea, vomiting, diarrhea, headache, skin tingling, and weakness. Sore palms of the hands and soles of the feet, trouble seeing, fever, and abdominal pain may also occur. Severe side effects may include low blood pressure, decreased level of consciousness, kidney problems, and low blood cell levels. It is unclear if it is safe when breastfeeding.

Suramin was made at least as early as 1916. It is on the World Health Organization's List of Essential Medicines, the safest and most effective medicines needed in a health system. In the United States it can be acquired from the Centers for Disease Control (CDC). The cost of the medication for a course of treatment is about US$27. In regions of the world where the disease is common suramin is provided for free by the World Health Organization (WHO)."
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This one's been kicking around for years [suramin as a treatment for ME/CFS*]; possibly Chris Ponting's GWAS study might provide an indication re a role for purinergic signaling in ME/CFS @Simon M

*""People who suffer from Long COVID Syndrome and ME/CFS have nearly identical physical symptoms and there may be a similarity in the underlying pathophysiology related to mitochondria and purinergic signaling. Using a purinergic antagonist, like suramin, may play an important role in addressing both of these syndromes," commented Robert Naviaux, MD, PhD and co-Director of the Mitochondrial and Metabolic Disease Center at the UCSD School of Medicine."
[https://www.prnewswire.com/news-rel...ts-with-long-covid-19-syndrome-301456006.html]
 
It'll be good to have a proper trial on it as a potential treatment, as no-one's likely to get the funding for an ME trial unless these results are promising. I suspect the most likely outcome is inconclusive, as with most things, but I suppose there's a chance it'll be clearer!
 
"People who suffer from Long COVID Syndrome and ME/CFS have nearly identical physical symptoms" this is becoming a pervasive meme that seems based on nothing more than pronouncements from authority. Post Covid symptoms include a whole range of things that have never been reasonably linked to ME/CFS - Long-COVID and Post-COVID Health Complications: An Up-to-Date Review on Clinical Conditions and Their Possible Molecular Mechanisms

There may be a subset of Long COVID symptoms that equate to ME/CFS but that's a very different thing from saying LC = ME/CFS.
 
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CRG said:
There may be a subset of Long COVID symptoms that equate to ME/CFS but that's a very thing from saying LC = ME/CFS.
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Are we seeing a naming problem? Some people use Long Covid to include any long term sequelae including the structural damage arising from the initial infection, and others seem to use it for just the ME type symptoms.

I would agree it is too early to make categorical pronouncements on this. It could turn out that Long Covid is a unitary condition including some people with ME like symptoms or that it is a heterogeneous grouping that for some includes triggering of ME, but we don’t yet have clarity.
 
This is exciting.. Ron Davis and Naviaux both wanted to try this for us, but couldn’t access the drug. Great it will get done regardless.
 
Peter Trewhitt said:
Are we seeing a naming problem? Some people use Long Covid to include any long term sequelae including the structural damage arising from the initial infection, and others seem to use it for just the ME type symptoms.

I would agree it is too early to make categorical pronouncements on this. It could turn out that Long Covid is a unitary condition including some people with ME like symptoms or that it is a heterogeneous grouping that for some includes triggering of ME, but we don’t yet have clarity.
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It's not the surprising that non medics/researchers mix up names but for someone like Naviaux to get in on the act is IMO unacceptable. After all the decades of trying to get meaningful diagnostic criteria widely accepted, to then have ME/CFS bundled into an even bigger waste basket of diverse symptoms seems spectacularly retrograde.

We really need all commentators to use some intelligence and acknowledge that there is chronological cross over between post infection syndromes and ME/CFS but that does not in anyway confirm common pathology. Without some grasp of the respective pathophysiologies and some means to distinguish between them (biomarkers) the fact that a post infection syndrome case meets ME/CFS criteria at 6 months is only indicative that ME/CFS is heterogenous and if that particular case resolves within say two years there's no evidentiary basis on which to state that it is either definitively short duration ME/CFS or definitively long duration PIS.
 
You forget that CFS simply requires 6 months of fatigue in the UK and some additional symptoms in the US. By these definitions long covid is the same as CFS. We prefer the name ME/CFS and then many of us just say ME (4 less characters!) so longcovid is ME.

It is not right, but it is what we have had to live with for almost forty years. None of us really know if what we have will still be ME if proper diagnostic tests are discovered.
 
Agree with the comments above. I suppose small biotech companies like PaxMedica have an interest in conflating Long Covid and ME/CFS because it implies a larger pay-off if the drug is found to work which helps raise $$ from investors. The problem, as others point out, is that this study's definition of Long Covid potentially risks pulling in patients who have lingering but ultimately self-resolving effects from a COVID infection that have no connection at all to chronic post-viral illness.

Separately, can anyone with more medical knowledge than me explain what a 'purinergic antagonist' is? I'm trying to wrap my head around how Suramin works and why it might be useful to Long Covid, ME/CFS or both. I recall that in 2018 Ron Davis asserted that ME/CFS has the same gene expression as people infected with Trypanosomes (could this be an autoantibody thing?) - is this why Suramin is deemed a potential treatment? What about a drug like Fexinidazole which can be taken orally (Suramin I think is IV only)? See: https://en.wikipedia.org/wiki/Fexinidazole

Any thoughts welcome - I'm out of my depth!
 
Mithriel said:
You forget that CFS simply requires 6 months of fatigue in the UK and some additional symptoms in the US. By these definitions long covid is the same as CFS. We prefer the name ME/CFS and then many of us just say ME (4 less characters!) so longcovid is ME.

It is not right, but it is what we have had to live with for almost forty years. None of us really know if what we have will still be ME if proper diagnostic tests are discovered.
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Sorry, that's now inaccurate. The new guideline says

1.2.2 Suspect ME/CFS if:

  • the person has had all of the persistent symptoms in box 2 for a minimum of 6 weeks in adults and 4 weeks in children and young people and

  • the person's ability to engage in occupational, educational, social or personal activities is significantly reduced from pre‑illness levels and

  • symptoms are not explained by another condition.
All of these symptoms should be present:

  • Debilitating fatigue that is worsened by activity, is not caused by excessive cognitive, physical, emotional or social exertion, and is not significantly relieved by rest.

  • Post-exertional malaise after activity in which the worsening of symptoms:


    • is often delayed in onset by hours or days

    • is disproportionate to the activity

    • has a prolonged recovery time that may last hours, days, weeks or longer.


  • Unrefreshing sleep or sleep disturbance (or both), which may include:


    • feeling exhausted, feeling flu-like and stiff on waking

    • broken or shallow sleep, altered sleep pattern or hypersomnia.


  • Cognitive difficulties (sometimes described as 'brain fog'), which may include problems finding words or numbers, difficulty in speaking, slowed responsiveness, short-term memory problems, and difficulty concentrating or multitasking.
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https://www.nice.org.uk/guidance/ng206/chapter/Recommendations#suspecting-mecfs
 
Andy said:
Sorry, that's now inaccurate. The new guideline says


https://www.nice.org.uk/guidance/ng206/chapter/Recommendations#suspecting-mecfs
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that may be what the new guidelines say but as to what is happening in practice is another matter

according to the NHS
Guidelines for diagnosing ME/CFS
Guidelines from the National Institute for Health and Care Excellence (NICE) say doctors should consider diagnosing ME/CFS if a patient has extreme tiredness that cannot be explained by other causes and the tiredness:

  • started recently, has lasted a long time, or keeps coming back
  • means you cannot do the things you used to do
  • gets worse after activity or gentle exercise, such as a short walk
You must also have some of these symptoms:

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https://www.nhs.uk/conditions/chronic-fatigue-syndrome-cfs/diagnosis/
 
Andy said:
Sorry, that's now inaccurate. The new guideline says


https://www.nice.org.uk/guidance/ng206/chapter/Recommendations#suspecting-mecfs
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You are right, I was incorrect. It is a vast improvement from a respected British institution so may be a force for good. I don't believe all longcovid is ME I was just being sarky and annoyed about the thinking we face :)

I very much hope it takes hold of medical thinking this time. Half decent definitions come along but just join a long list of the list of things about ME which are ignored. The CBT and GET brigade are very good at twisting things to suit themselves and the idea that chronic fatigue is CFS (which patients prefer to call ME) had become endemic in medical thinking.

ME will become drowned out by longcovd if the 2 things are assumed to be the same.
 
chrisb said:
That is fine if you are happy with a definition which is so undiscriminating.
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Here, again, are the list of required symptoms, that a patient needs to have had for a minimum of 6 weeks. Why, or where, exactly do you think that they are lacking in discrimination?

All of these symptoms should be present:

  • Debilitating fatigue that is worsened by activity, is not caused by excessive cognitive, physical, emotional or social exertion, and is not significantly relieved by rest.

  • Post-exertional malaise after activity in which the worsening of symptoms:

    • is often delayed in onset by hours or days

    • is disproportionate to the activity

    • has a prolonged recovery time that may last hours, days, weeks or longer.


  • Unrefreshing sleep or sleep disturbance (or both), which may include:

    • feeling exhausted, feeling flu-like and stiff on waking

    • broken or shallow sleep, altered sleep pattern or hypersomnia.


  • Cognitive difficulties (sometimes described as 'brain fog'), which may include problems finding words or numbers, difficulty in speaking, slowed responsiveness, short-term memory problems, and difficulty concentrating or multitasking.
 
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