Tonix Pharmaceuticals will target long Covid-19 in a Phase II trial set to start in the first half of this year, CEO Seth Lederman says. The trial will investigate its trimodal receptor antagonist TNX-102, which is also in development for fibromyalgia and other sleep-related disorders.
The trial will target the approximately two-thirds of long Covid-19 patients whose symptom profiles are consistent with the idiopathic condition fibromyalgia, Lederman notes. The fibromyalgia and long Covid-19 symptoms that overlap include fatigue, body pain, sleep problems, and brain fog.
TNX-102 primarily targets sleep improvement, which could translate to overall improvement in other facets of fibromyalgia and long Covid-19, Lederman explains. “Nobody really knows what causes fibromyalgia, but for years people have speculated that it might be a postviral syndrome,” he adds. “Our view on long Covid-19 is that it is either related to fibromyalgia or maybe a form of fibromyalgia.”
thanks for posting. I had seen this one being mentioned but we do not typically post about trials untiol they get to phase 3 and efficacy data has more confidence attached. I think there are a couple of drugs in P2 at present with some failing recently as well. Lets hope this one progresses to P3 and an eventual license.
thank you, i understand. It looks they might be already near the phase 3 if i am not wrong
" TNX-102 SL (cyclobenzaprine HCl sublingual tablet), is in mid-Phase 3 development for the management of fibromyalgia with a new Phase 3 study launched in the second quarter of 2022 and interim data expected in the first quarter of 2023. "
desquinnPartnerVolunteerFMAUK Trustee• in reply toJoseT
The P3 trials are spotty with this one IIRC with most of them not proceeeding but one proceeding despite the negative or not positive may be fairer result of the trial but due to some issues with trial design or some positive signals from some other source.
So it is still open and there is still hope but with trials and drug development I would wait until they publish positive papers after P3. But do see when things like this are published.
Just for FYI, when it is post P3 then it is potentially to be reviewed for a license by FDA and then elsewhere and able to be produced and sold. When we started to get specific meds for fibro in 2007+ milnaciprin was one of the 3 and it has still not achieved a licenece in the EU so even efficacy and safety data does not get it over the line.
But its great to see the progress that is happening.
Is it the pharmaceutical company doing the experiment?
I just want a drug that kills me, I’m fed up with the excessive pain in every cell of my body and brain. 🤯🤯
desquinnPartnerVolunteerFMAUK Trustee• in reply toPainny
mixed messages in your post It is a pharma company but not one I had much knowledge off but they have a couple of facilities so do have significant resources. Nearly all meds come through pharma.
As to your other point I would reach out to GP and see about other options to handle the pain.
Thank you for sharing that as a fibromyalgia and long civid sufferer it brings me hope. Although Ireland are always way behind I have just yesterday been referred to a long civid clinic so hopefully I will get somewhere and will show them this information in the hope that it may help even if they only look into it further themselves for now it is a step in the right direction 😀
Like you a fibro and long covid sufferer, plus a few other chronic conditions, and after 20 months with breathlessness, raised heart rate after minimal effort ( getting dressed) and no sense of smell got referred to Long Covid clinic ( run by breathing physio) . Got lung X-ray, and ultrasound of heart done independently …ok. Had to do extensive questionnaire, which was discussed at an hour clinic appointment, but it wasn’t really geared up to those who already have fibro. We settled on that Long Covid gave me 10% more exhaustion, fatigue, brain fog, all over pain etc etc than I had before, but it could be 30-40%…. And that was about it save for being told to try to make sure I breath from my stomach. Be interesting to hear if you get anything else, particularly something that works…it would be so good to get some drug that relieved at least some of these wretched symptoms.
I just got my referral to long covid clinic so yes I am very interested to see what they say. My local hospital are still setting up a clinic but the infectious disease deparemt are temporarily dealing with it unoffically so I got referred to both. I just hope they can help with my thinking and speaking ability as its so frustrating not to have a proper conversation or to be able to finish my studies.
Other than the fact I mentioned worse ability to remember words, and general brain fog, I am not even sure it was recorded in the consultation , tho was on questionnaire…nothing was offered re.that, but as the lead is a respiratory physio I am not surprised. The fact that infectious diseases are involved might mean the clinic has a completely different spin. You in Ireland/Eire or Northern Ireland, just curious to know where all the data from patients will end up? I had hoped for so much when it was becoming clear the first descriptions of Long Covid sounded so similar to fibro. but sadly I think it’s largely lip service…the majority of LC suffers being more mature women. Anyway good luck, hope you find a bit more help.
Oh I hope I they help I really do. I heard hydrocarbonic oxygen is brilliant probably spelled wrong but the clinical nurse I spoke to said she knew of 3 personal friends who were very bad and it has made huge improvements so that may be worth trying.
It has been here in ireland with long covid clinics only available in dublin but its slowly starting to open elsewhere but very slowly. The hyperbaric oxygen is through private companies and is expensive but so is everything else here health system is awful if you can afford it may be worth investigating it as a possible option
recent interview about fibro and long with covid with Dr. Seth Lederman, the Co-Founder and CEO of Tonix Pharmaceuticals and the developer of TNX-102, the drug to treat both syndromes. The drug is aimed to improve the restored sleep which according to Dr Lederman is probably one of the keys to resolve these illnesses :
Thanks for sharing, this is really, really impressive - well-informed, Lederman himself as well as the interviewer, and informative, cutting edge, not just as regards the drug Tonix is developing, also up front with FM pain seeming to be "nociplastic", well explained.
I'll put my own notes from it in here, maybe someone's interested. 35 mins, from 7' to 41'.
But first my main contention, unfortunately, that it's not my experience that restorative sleep helps any of the other FM symptoms, at least not much:
For my 3rd CoV-jab I again took an antihistamine like for the 2nd one. However this time my sleep got much better, better than ever since I've been in my fibro full flare. (Only in combination with my other supps, esp. GABA and passiflora, as well as sleep recommendations, like Huberman's), Interesting that the antihistamine added helps, because TNX-102 also targets the histamine receptors as well as 2 others. So I've decided to keep taking that antihistamine, it seems to have no bad side effects. Despite not having half as strong histamine-y MCAS reactions from the jab no. 3, bivalent, as from the 2nd. My 'maximum energy' has decreased another 5% long term from this jab, like after each before, but it is now more stable: 10-20%, instead of before 5-25%. The jab was over 2 months ago, and I can't see hints of recovery this time. Since the 2nd jab I haven't changed anything much I can see as relevant apart from Chinese acupuncture for a bit more energy, not working any more, and better sleep supps - Huberman's magnesium threonate and apigenin.
So restorative, short, effective sleep, usually only 4 sleep breaks, 30 minutes, but the only effect may be on the stability of my reduced fatigue, not pain, or fog, and as said energy worse. Wonderful tho in itself, even tho I'd got my 7-8 sleep breaks down to under an hour a night before, and also fairly restorative. Now I can often just sleep 6.5 or 7h, that was never possible before, I had to aim for 9h of deep sleep or NSDR every single day.
So these are my notes....:
Instead of FM, the parent orga of FDA did a report the National Research Action Plan 19x refer to the connection to CFS, 0x FM.
But funnily there are NO FDA-approved meds for CFS, as opposed to for FM.
Lederman was a doc (assistant professor) before he went into pharma, clinical experience with FM.
16’53’’ TNX 102-1SL tries to target all 4 main FM-symptoms. It's for bedtime, improves sleep quality, critical symptom, Achilles heel of FM, good for the others too. Not a tranquiliser or a sedative, these get you to sleep quicker, decrease sleep latency, but they knock you out, it’s not restorative. With TNX 102 you only get benefits after 10-14 days, resets the sleep cycle.
It works on 3 different receptors: serotonin receptor type 2, histamine receptor (so like antihistamine) and alpha adrinergic receptors (epinephrin / adrenalin) - with that one single drug. Not knocked out.
It making sleep restorative can hopefully help people heal. Studies only test if 3 months makes them better in the end, but it is hopefully for long term use & help, to reduce pain, fatigue & fog. Specifically for FM sleep. Central sensitisation praps too.
27’. TONIX medical chart review from very big data base 50.000 with Long Covid: 40% of these have multi site pain too. 30’ The amount of 20% getting Long Covid will likely grow, it could decimate the health of Americans. 25% of people with Long Covid are unable to return to work in the US.
32’ TNX 102 is taken sublingually every night, 2+12=14 weeks. Focusing only on pain in both studies. Since pain was important for the FDA when approving the 3 FM drugs, TONIX is confident that they’ll approve of this for Long Covid too. Smartphone app.
34’ Company’s website. tonixpharma.com Beta-App is. 30 sites across the US are actively recruiting for each of the 2 studies.
36’ Pain is a subjective experience, but many other human experiences are subjective too. Pain in animals [maybe pain in animals shows that pain is more similar than other experiences??]. Pain levels, average has over a 4, praps 7, down with treatment. Understanding of pain improves. Shameful opiate crisis in the US. 3 types of pain: nociceptive, neuropathic, nociplastic, with examples. Also affects all 5 senses. Bit like a broken thermostat. Its repair is praps easier cos it seems a software rather than a hardware problem. -41’
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It is a pharma company but not one I had much knowledge off but they have a couple of facilities so do have significant resources. Nearly all meds come through pharma.
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